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{ "NCT_ID" : "NCT01025778", "Brief_Title" : "Haploidentical Stem Cell Transplantation for Children With Therapy Resistant Leukemia", "Official_title" : "Clofarabine Based Remission Induction Followed by Haploidentical Stem Cell Transplantation in Children With Refractory Hematological Malignancies", "Conditions" : ["Acute Lymphoblastic Leukemia", "Acute Myeloid Leukemia"], "Interventions" : ["Drug: Thiotepa in conditioning before transplantation", "Drug: Etoposide for remission induction", "Drug: Cyclophosphamide for remission induction", "Drug: Clofarabine in conditioning before transplantation", "Procedure: Haploidentical transplantation of T-cell depleted graft", "Drug: Melfalan in conditioning before transplantation", "Drug: Clofarabine for remission induction", "Procedure: Donor lymphocyte infusion"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Despite substantial progress in the treatment pediatric acute leukemia a significant number of children will experience primary or secondary resistance to the treatment. In other words it will be not possible to achieve remission using standard chemotherapy (primary resistance) or the patients will develop chemotherapy resistant relapse (secondary resistance). Children failing to achieve remission or children relapsing after previous allogeneic stem cell transplantation have short life expectancy and palliative treatment still remains the most reasonable option as the escalation of conventional chemotherapy is not longer effective. The role of Graft versus Leukemia effect was postulated as one of the mechanisms contributing to the leukemia control/eradication after transplantation of hematopoietic stem cells. In this study the investigators combine intensified multiagent Clofarabine containing chemotherapy with post-induction treatment intensification using reduced intensity conditioning followed by haploidentical hematopoietic stem cell transplantation. Introducing a new drug to the treatment of resistant leukemia the investigators want to achieve a response which allows us to proceed to immediate haploidentical transplantation. Using a haploidentical donor the investigators can avoid time consuming search for an unrelated donor and perform the transplantation at the optimal time-point. Combating therapy resistant leukemia the investigators would like to evoke and utilize potential Graft-versus-Leukemia effect which is much more pronounced in the haploidentical setting, as it is well documented that allogeneic transplantation with a matched donor is not effective in resistant disease. The use of best KIR mismatch donor and post-transplant donor lymphocyte infusion will be implemented in order to develop/intensify graft versus leukemia effect. #Intervention - DRUG : Clofarabine for remission induction - DRUG : Etoposide for remission induction - DRUG : Cyclophosphamide for remission induction - DRUG : Clofarabine in conditioning before transplantation - DRUG : Thiotepa in conditioning before transplantation - DRUG : Melfalan in conditioning before transplantation - PROCEDURE : Haploidentical transplantation of T-cell depleted graft - PROCEDURE : Donor lymphocyte infusion

#Eligibility Criteria: Inclusion Criteria: Target population * Refractory acute lymphoblastic leukemia * Chemoresistant isolated or combined bone marrow relapse * Relapse after during/after conventional treatment * Relapse >=6 months after allogeneic stem cell transplantation * Primary induction failure * Isolated extramedullary relapse after previous HSCT (>6 months) * Refractory acute myeloblastic leukemia including sAML * Chemoresistant relapse * Relapse after during/after conventional treatment * Relapse >=6 months after allogeneic stem cell transplantation * Primary induction failure Inclusion criteria to start induction treatment with multidrug regimen * Age >= 1 and <=21 years * Patients with previous HCST >= 6 m * Provide signed written informed consent patients', and patients' parents /guardians * Older children should be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent as well. * Cardiac output SF >=25% * Have adequate renal and hepatic functions as indicated by the following laboratory values: * Calculated creatinine clearance >=90 ml/min/1.73 m2 * Serum bilirubin <=1.5 X upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 X ULN * Alkaline phosphatase <= 2.5 X ULN * Performance score of >=70% (Lansky or Karnofsky) * A suitable haploidentical family member available for stem cell donation, > 18 years, fulfilling institutional criteria for blood and marrow donation. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Inclusion criteria to proceed to transplant after induction * Cardiac output SF >=25% * Have adequate renal and hepatic functions as indicated by the following laboratory values: * Calculated creatinine clearance >=90 ml/min/1.73 m2 * Serum bilirubin <=1.5 X upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 X ULN * Alkaline phosphatase <= 2.5 X ULN * Performance score of >=70% (Lansky or Karnofsky) * A suitable haploidentical family member available for stem cell donation, > 18 years, fulfilling institutional criteria for blood and marrow donation. * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. * Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Exclusion Criteria: * Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol. * Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy. * Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. * Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). * Pregnant or lactating patients. * Any significant concurrent malignant disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results. Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01025778

{ "NCT_ID" : "NCT01718691", "Brief_Title" : "Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma", "Official_title" : "Phase II Clinical Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B-cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (Multicenter, Open-label).", "Conditions" : ["Low-grade B Cell Non-Hodgkin's Lymphoma", "Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated"], "Interventions" : ["Drug: SyB L-0501", "Drug: rituximab"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated. #Intervention - DRUG : SyB L-0501 - A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. - DRUG : rituximab - A dose of 375 mg/m\^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.

#Eligibility Criteria: Inclusion Criteria: * Patients who are histopathologically confirmed to have the following cluster of differentiation 20 (CD20) positive low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma by lymph node biopsy or evaluable tissue biopsy within 6 months before the registration WHO Classification of Tumors (fourth edition): * Small lymphocytic lymphoma * Splenic marginal zone B-cell lymphoma * Lymphoplasmacytic lymphoma * Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) * Nodal marginal zone B-cell lymphoma * Follicular lymphoma (Grade 1, 2, 3a) * Mantle cell lymphoma * Patients with a measurable lesion ( > 1.5 cm in major axis on CT) * Patients without a medical history * Patients with at least 1 of the following clinical symptoms or signs (excluding mantle cell lymphoma): * Bulky disease measuring > 7 cm in major axis on CT (excluding spleen) * B symptoms 1. Fever exceeding 38.0ºC of unknown cause 2. Night sweats 3. Weight decrease exceeding 10% within 6 months before patient registration * Elevated serum LDH or beta 2 microglobulin * Three or more regional lymph nodes of > 3 cm in major axis on CT * Symptomatic splenomegaly * Intracranial pressure * Pleural effusion/ascites retention * Patients expected to live for at least 3 months * Patients aged between 20 and 79 years (at the time of registration) * Patients whose Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) is 0～2 * Patients with adequately maintained major organ function (bone marrow, heart, lungs, liver, kidneys) * Neutrophil count: not less than 1,500 /mm3 * Platelet count: not less than 75,000 /mm3 * Aspartate aminotransferase (AST)[Glutamic oxaloacetic transaminase (GOT)]: not more than 3 times the standard upper limit for the site * Alanine aminotransferase (ALT)[Glutamic pyruvic transaminase (GPT)]: not more than 3 times the standard upper limit for the site * Total bilirubin: not more than 1.5 times the standard upper limit for the site * Serum creatinine: not more than 1.5 times the standard upper limit for the site * Arterial partial pressure of oxygen (PaO2): not less than 65 mmHg * Electrocardiogram shows no abnormal findings that require treatment * Echocardiogram of left ventricular ejection fraction (LVEF): not less than 55% * Patients whose informed consent has been obtained in person Exclusion Criteria: Patients who fall under any one of the following criteria are to be excluded * Patients whose transformation has been confirmed histopathologically * Mantle cell lymphoma patients aged 65 years or younger * Patients who were administered or received transfusion of cytokine formulations such as G-CSF (granulocyte colony stimulating factor) and erythropoietin within 14 days before pre-registration test * Patients with severe active infectious disorders (receiving antibiotics, antifungals, or antivirus IV injection) * Patients with serious complications (such as hepatic or renal failure) * Patients with severe complications of cardiac disease (examples: myocardial infarction, ischemic heart disease) or its previous history within 2 years before patient registration, and patients with arrhythmia requiring a treatment * Patients with serious gastrointestinal conditions (persistent or severe nausea/vomiting or diarrhea) * Patients who are positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody or HIV antibody [if HBs or hepatitis B core (HBc) positive, patients whose hepatitis B virus (HBV)-DNA test results indicate positive] * Patients with serious bleeding tendencies [such as disseminated intravascular coagulation (DIC)] * Patients having or suspected of having symptoms indicative of the central nervous system (CNS) involvement * Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema complications requiring treatment or its medical history. * Patients with active multiple primary cancer * Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor steroid therapy in the past * Patients with complications or medical history of autoimmune haemolytic anaemia * Patients who were administered investigative or unapproved drugs within 3 months before patient registration * Patients with addiction to drugs or narcotics, or alcoholism * Patients who have previously received hematopoietic stem cell transplantation * Patients who are or may be pregnant, lactating patients * Patients, whether male or female, who do not agree to use contraception * Patients otherwise judged by the investigator or the sub-investigator to be unsuitable for inclusion in the study Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01718691

{ "NCT_ID" : "NCT01317940", "Brief_Title" : "Nutrition and Body Composition in Acute Lymphoblastic Leukemia", "Official_title" : "Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)", "Conditions" : ["Precursor Cell Lymphoblastic Leukemia-Lymphoma", "Vitamin D Deficiency"], "Interventions" : ["Dietary Supplement: Vitamin D and Calcium Citrate"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue. In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density. #Intervention - DIETARY_SUPPLEMENT : Vitamin D and Calcium Citrate - Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day for approximately 6-7 months - Other Names : - 1,25-Dihydroxycholecalciferol, Calcitriol, Rocaltrol (Roche), Calcium carbonate

#Eligibility Criteria: Inclusion Criteria: GROUP A: Patients with newly diagnosed ALL * Are greater than or equal to 10 years and less than or equal to 21 years at diagnosis of ALL * Have a new diagnosis of untreated ALL classified as 'high risk' per NCI criteria (due to being greater than 10 years) * Are beginning treatment with a Children's Cancer Group/Children's Oncology Group 'high risk' protocol with a 4-drug induction including steroids * Are not pregnant GROUP B: Early survivors of ALL * Were treated for ALL and remain in first CR1 (complete remission) * Were equal to or greater than 10 years and less than or equal to 21 years at diagnosis of ALL * Have completed treatment on or as per a Children's Cancer Group/Children's Oncology Group 'high risk' protocol between 12 and 48 months prior to enrollment in this study (consisting of a plan for a 4-drug induction including steroids in Induction, Delayed Intensification, and steroid pulses in Maintenance. Steroids are allowed to have been discontinued due to toxicity). * Are not pregnant GROUP C: Siblings of Group A * Are either a full-sibling or a half-sibling of a patient in Group A * Are living at the same residence as the sibling/half-sibling from Group A * Are greater than or equal to 10 years and less than or equal to 21 years at the time of study entry, and within 3 years of the age diagnosis of ALL in the sibling/half-sibling from Group A * Are on the same Vitamin D supplementation regimen (if any) as the sibling from Group A at the time of his or her diagnosis Exclusion Criteria (All Groups): * Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal bone development * Are undergoing treatment with other medicines that affect bones including chronic use of of steroids, bisphosphonate therapy, or Vitamin D at average dose greater than 400 international units (IU)/day * Have an underlying diseases altering body structure (i.e. missing a limb, severe dysmorphism) or severely affecting mobility (i.e. total or hemiparesis) * Have a history of chemotherapy or radiation for other cancers * Cannot complete the radiology exams/radiology exams uninterpretable (i.e. people with a hip replacement or prosthesis) Sex : ALL Ages : - Minimum Age : 10 Years - Maximum Age : 29 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT01317940

{ "NCT_ID" : "NCT00928798", "Brief_Title" : "Topical Rapamycin for Fibrofolliculomas", "Official_title" : "Topical Rapamycin to Treat Fibrofolliculomas in Birt-Hogg-Dubé Syndrome", "Conditions" : ["Birt-Hogg-Dubé Syndrome"], "Interventions" : ["Drug: placebo", "Drug: Rapamycin"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of the study is to determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the growth of new ones. Secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction. #Intervention - DRUG : Rapamycin - Application of rapamycin 1 mg/ml oral solution to one predefined skin area on one facial half, twice daily 0,25 ml, during 6 months. The other facial half will be similarly treated with a placebo. - Other Names : - Rapamune, Sirolimus - DRUG : placebo - Application of placebo to one predefined skin area on one facial half, during 6 months. The other facial half will be similarly treated with rapamycin 1 mg/ml oral solution

#Eligibility Criteria: Inclusion Criteria: * Minimum age of 18 years. * At least 10 facial fibrofolliculomas, histologically confirmed. * Entered in a screening program and free of malignancy as determined during screening (already had a baseline MRI or CT-scan). * Being able to understand instructions. * Mutation status must be known. * For females: not pregnant and willing to use both oral and barrier contraceptives during the treatment period. Exclusion Criteria: * Not capable of informed consent. * Age under 18 years. * Pregnancy or failure to comply with contraceptive measures. * Proven or suspected malignancy of skin or other organs. * No histological confirmation. * Skin lesions other than fibrofolliculoma that might worsen under sirolimus such as active infections. * Not able to comprehend instructions. * No proven mutation. * Less than 10 fibrofolliculomas. * Planned facial surgery in the treatment period. * Concomitant disease requiring systemic immunosuppressive treatment * Concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trail period or in the 30 days before start trial. * Tendency to form keloids or hypertrophic scars. * Drug or alcohol abuse. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00928798

{ "NCT_ID" : "NCT00866918", "Brief_Title" : "Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia", "Official_title" : "Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation", "Conditions" : ["Childhood Acute Promyelocytic Leukemia With PML-RARA", "Myeloid Neoplasm"], "Interventions" : ["Drug: Mercaptopurine", "Drug: Methotrexate", "Drug: Idarubicin", "Drug: Cytarabine", "Drug: Mitoxantrone Hydrochloride", "Drug: Arsenic Trioxide", "Other: Diagnostic Laboratory Biomarker Analysis", "Drug: Tretinoin"], "Location_Countries" : ["Puerto Rico", "Canada", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Detailed Description PRIMARY OBJECTIVES: I. To decrease the total anthracycline dose from the best current published results in standard risk childhood acute promyelocytic leukemia (APL) while still maintaining a comparable event-free survival (EFS). SECONDARY OBJECTIVES: I. To assign treatment based on risk stratification by white blood cell count (WBC) at diagnosis. II. To estimate the induction failure rate, toxic death rate, disease-free survival rate and overall survival rate in both standard and high risk APL patients. III. To monitor for cardiotoxicity in an idarubicin/mitoxantrone based regimen. IV. To document the toxicity of a traditional chemotherapy/all-trans retinoic acid (ATRA) (tretinoin) based regimen combined with arsenic trioxide therapy. V. To study the relationship of Fms-like tyrosine kinase 3 (FLT3) mutations to clinical features and outcome in APL. VI. To study risk factors for pseudotumor cerebri in APL. VII. To study the relationship of early progenitor cell involvement to treatment failure in FLT3 positive APL. VIII. To compare the EFS of children enrolled on AAML0631 with the EFS of children enrolled on C9710 who were between the ages of 2 and 21 and did not receive arsenic trioxide. IX. To estimate the proportion of patients who carry a cryptic t(15;17), i.e., those who are positive for a promyelocytes.(PML)-retinoic acid receptor alpha (RARA) fusion transcript by polymerase chain reaction (PCR) analysis but have normal chromosomes. X. To estimate the proportion of patients with variant RARA partners. XI. To compare the outcome of patients with only a t(15;17) with that of patients who carry a t(15;17) and other chromosomal abnormalities. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 arms based on risk factor (standard-risk \[WBC less than 10,000/mm\^3\] or high-risk \[WBC 10,000/mm\^3 or higher\]). ARM I (STANDARD-RISK): INDUCTION THERAPY: Patients receive tretinoin orally (PO) twice daily (BID) on days 1-30 and idarubicin intravenously (IV) over 15 minutes once on days 3, 5, and 7. CONSOLIDATION THERAPY: CONSOLIDATION 1: Patients receive arsenic trioxide IV over 2 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33 and tretinoin PO BID on days 1-14. Treatment repeats every 5 weeks for 2 courses, followed by a 2-week break, and then treatment repeats for 2 more courses. Beginning 1 week later or when blood counts recover, patients proceed to consolidation 2. CONSOLIDATION 2: Patients receive cytarabine intrathecally (IT) on day 1, tretinoin PO BID on days 1-14, high-dose cytarabine IV over 3 hours every 12 hours on days 1-3, and mitoxantrone hydrochloride IV over 15-30 minutes once on days 3 and 4. Patients proceed to consolidation 3 1 week later or when blood counts recover. CONSOLIDATION 3: Patients receive cytarabine IT on day 1, tretinoin PO BID on days 1-14, and idarubicin IV over 15 minutes once daily on days 1, 3, and 5. High-risk patients and those standard-risk patients who are positive for minimal residual disease by real-time quantitative (RQ)-PCR receive consolidation 4 one week later or when blood counts recover. All other standard-risk patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive cytarabine IT on day 1 (course 1 only), tretinoin PO BID on days 1-14, mercaptopurine PO once daily (QD) on days 1-84, methotrexate PO once on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 9 courses. ARM II (HIGH-RISK): INDUCTION THERAPY: Patients receive tretinoin PO BID on days 1-30 and idarubicin IV over 15 minutes once on days 1, 3, and 5. Patients proceed to consolidation therapy one week later or when blood counts recover. CONSOLIDATION THERAPY: Patients receive consolidation 1, 2, and 3 as in Arm I. CONSOLIDATION 4: Patients receive cytarabine IT on day 1, tretinoin PO BID on days 1-14, high-dose cytarabine IV over 3 hours every 12 hours on days 1-3, and idarubicin IV over 15 minutes once on day 4. Patients who demonstrate molecular complete remission (CR) and remain in hematological CR proceed to maintenance therapy 1 week later or when blood counts recover. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm I. After completion of study treatment, patients are followed every month for 1 year, every 3 months for 2 years, every 6 months for 2 years, and then annually for 5 years. #Intervention - DRUG : Arsenic Trioxide - Given IV - Other Names : - Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid, Arsenous Acid Anhydride, Arsenous Oxide, ATO, Trisenox, White Arsenic - DRUG : Cytarabine - Given IT or IV - Other Names : - .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453 - OTHER : Diagnostic Laboratory Biomarker Analysis - Correlative studies - DRUG : Idarubicin - Given IV - Other Names : - 4-Demethoxydaunomycin, 4-Demethoxydaunorubicin, 4-DMDR - DRUG : Mercaptopurine - Given orally - Other Names : - 3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine, 6-Mercaptopurine, 6-Mercaptopurine Monohydrate, 6-MP, 6-Purinethiol, 6-Thiopurine, 6-Thioxopurine, 6H-Purine-6-thione, 1,7-dihydro- (9CI), 7-Mercapto-1,3,4,6-tetrazaindene, Alti-Mercaptopurine, Azathiopurine, Bw 57-323H, Flocofil, Ismipur, Leukerin, Leupurin, Mercaleukim, Mercaleukin, Mercaptina, Mercaptopurinum, Mercapurin, Mern, NCI-C04886, Puri-Nethol, Purimethol, Purine, 6-mercapto-, Purine-6-thiol (8CI), Purine-6-thiol, monohydrate, Purinethiol, Purinethol, U-4748, WR-2785 - DRUG : Methotrexate - Given orally - Other Names : - Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039 - DRUG : Mitoxantrone Hydrochloride - Given IV - Other Names : - CL 232315, DHAD, DHAQ, Dihydroxyanthracenedione Dihydrochloride, Mitoxantrone Dihydrochloride, Mitoxantroni Hydrochloridum, Mitozantrone Hydrochloride, Mitroxone, Neotalem, Novantrone, Onkotrone, Pralifan - DRUG : Tretinoin - Given orally - Other Names : - 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin

#Eligibility Criteria: Inclusion Criteria: * Patients must be newly diagnosed with a clinical diagnosis of acute promyelocytic leukemia initially by morphology (bone marrow or peripheral blood); bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted; APL is considered a hematological emergency and treatment should be initiated as quickly as possible without waiting for molecular or cytogenetic/fluorescence in situ hybridization (FISH) confirmation; for patients who are unable to begin receiving ATRA in a timely manner following a presumed diagnosis of APL, consideration should be given to initiating ATRA and proceeding with treatment outside of the AAML0631 protocol; if the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR to be eligible; patients without evidence of APL by bone marrow or peripheral blood morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment; in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes; NOTE: A lumbar puncture is not required to be enrolled on study; if the diagnosis of APL is known or suspected, extreme caution must be exercised in performing a lumbar puncture during active coagulopathy; in addition a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma if central nervous system (CNS) disease is suspected or proven; if CNS disease is documented, patients are still eligible * No minimal performance status criteria * The patient must not have received systemic definitive treatment for APL or other suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic; prior therapy with corticosteroids, hydroxyurea, or leukopheresis will not exclude the patient; if a patient received intrathecal cytarabine prior to the diagnosis of APL being known, the patient will still be eligible as long as they meet all other eligibility requirements Exclusion Criteria: * Pregnant women or nursing mothers are excluded; treatment under this protocol would expose an unborn child to significant risks; patients should not be pregnant or plan to become pregnant while on treatment; women and men of reproductive potential should agree to use an effective means of birth control; there is an extremely high risk of fetal malformation if pregnancy occurs while on ATRA in any amount even for short periods * Patients with a pre-existing prolonged QT Syndrome will not be eligible for this protocol due to the use of arsenic trioxide which can prolong the QT interval Sex : ALL Ages : - Minimum Age : 2 Years - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00866918

{ "NCT_ID" : "NCT01969448", "Brief_Title" : "Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction", "Official_title" : "A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction", "Conditions" : ["Ductal Carcinoma in Situ - Category", "Breast Cancer", "Prophylactic Mastectomy"], "Interventions" : ["Procedure: Inframammary Fold Incision or Lateral Radial Incision", "Device: Laser-assisted fluorescence angiography", "Drug: Indocyanine Green", "Procedure: Inframammary Fold Incision", "Procedure: Lateral Radial Incision"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times. #Intervention - PROCEDURE : Inframammary Fold Incision or Lateral Radial Incision - PROCEDURE : Lateral Radial Incision - PROCEDURE : Inframammary Fold Incision - DEVICE : Laser-assisted fluorescence angiography - Other Names : - Spy Elite, LifeCell. - DRUG : Indocyanine Green

#Eligibility Criteria: Inclusion Criteria: * Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction. * Patient must be 18 years or older. * Karnofsky Performance Scale of at least 80%. * Patient must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Cognitive impairment. * BMI < 18 or > 35 * Breast >800 grams or <100 grams in predicted weight. 'Breast' includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass. The sum total must be >100 g and <800 g. * History of radiation to the chest wall or breast being studied * Patients who have a history of allergy to iodides or iodinated contrast agents * Surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). If the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01969448

{ "NCT_ID" : "NCT01367652", "Brief_Title" : "Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions", "Official_title" : "A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fasted Conditions", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Letrozole"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted conditions. #Intervention - DRUG : Letrozole - 2.5 mg tablet - Other Names : - Femara - DRUG : Letrozole - 2.5 mg Tablet - Other Names : - Femara

#Eligibility Criteria: Inclusion Criteria: * No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: * Positive test for HIV, Hepatitis B, or Hepatitis C. * Treatment with known enzyme altering drugs. * History of allergic or adverse response to letrozole or any comparable or similar product. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01367652

{ "NCT_ID" : "NCT01957735", "Brief_Title" : "BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors", "Official_title" : "A Phase 1a/b Non-randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously to Patients With Solid Tumors", "Conditions" : ["Metastatic Cancer", "Cancer", "Solid Tumor"], "Interventions" : ["Drug: BP31510 in combination with chemotherapy", "Drug: BP31510 monotherapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors. Detailed Description This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1)and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors.In the Phase 1a portion of the trial, patients who meet eligibility parameters will receive 2 consecutive 72-hour infusions of BPM31510 twice weekly on Tuesday and Friday (i.e., Days 1, 4, 8, 11, 18, 22 and 25), essentially receiving BPM31510 treatment for 144 hours per week of each 28-day cycle. At each dose level of Arm 1 and Arm 2, patients will be treated for either 8 hours at minimum of outpatient monitoring or inpatient monitoring for the first 24-hrs of the first infusion of Cycle 1.All other treatments will be administered in an outpatient setting.Dose limiting toxicities will be assessed during Cycle 1. The study is a standard 3 + 3 dose escalation design with the dose escalated in successive cohorts of 3 to 6 patients each.Toxicity at each dose level will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.02). Safety oversight will be provided by the Cohort Review Committee (CRC).The CRC will review and confirm all DLTs and will continue to monitor safety throughout the study (including Arm 2). Assessments of the antitumor activity of BPM31510 will be performed at the end of Cycle 2 and every 2 cycles thereafter using standard techniques such as computerized tomography (CT) or magnetic resonance imaging (MRI) for patients with measurable disease.Response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 .Patients who experience no unacceptable toxicity or disease progression, may receive additional 28-day cycles for up to 1 year on Arm 1 or 2. Patients on Arm 1 who progress may elect to continue BPM31510 treatment in combination with gemcitabine, 5-FU, or docetaxel at the treating physician's discretion. Once a dose level of BPM31510 monotherapy is evaluated and the CRC determines it safe to escalate to the next dose level, Cohort 1 of Treatment Arm 2 of BPM31510 in combination with chemotherapy will open to accrual. Cohort 1 of Arm 2 patients will be enrolled onto one of 3 chemotherapies, gemcitabine, 5-FU, or docetaxel. Cycle 1 of combination therapy (Arm 2) is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesday and Friday for 6 weeks and chemotherapy administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesday and Friday for 4 weeks and chemotherapy administered on Mondays, Days 7, 14 and 21. Dose limiting toxicities will be assessed during Cycle 1. Response will be assessed after Cycle 2 (10 weeks) and responders who continue onto Cycles 2-12 will be assessed every 2 cycles (8 weeks). Patients who progress and crossover to Arm 2 will be reconsented and must meet eligibility before restarting BPM31510. Crossover patients are not evaluated for DLTs on Arm 2 and all cycles of combination therapy are 4 weeks in duration (Cycles 1-12). BPM31510 is administered twice weekly on Tuesdays and Fridays for 4 weeks and chemotherapy administered on Mondays, Days 7, 14 and 21 for all crossover patients on Arm 2. Patients will continue BPM31510 in combination with chemotherapy for a maximum of 12 cycles in the absence of intolerable toxicity and progression. Patients on Arm 2 who progress on one type of chemotherapy may not switch to one of the other chemotherapy agents in combination with BPM31510.However, if the chemotherapy component (ie, 5-FU, gemcitabine, or docetaxel) of combination therapy is discontinued due to chemotherapy-related toxicity, patients may continue to receive BPM31510 as monotherapy. Once the maximum tolerated dose (MTD) of BPM31510 as monotherapy and in combination with chemotherapy are established, an expansion cohort will be enrolled (a total of 12-15 patients for monotherapy and a total of 10 patients for each combination therapy). #Intervention - DRUG : BP31510 monotherapy - DRUG : BP31510 in combination with chemotherapy

#Eligibility Criteria: Inclusion Criteria: * The patient has a histologically confirmed solid tumor that is metastatic or unresectable for which standard measures do not exist or are no longer effective. (Patients with primary brain cancer or lymphoma are permitted. Patients with brain metastases are allowed if whole brain radiation was performed and is documented stable for >= 6 weeks) * The patient is at least 18 years. * The patient has an Eastern Cooperative Oncology Group (ECOG) performance status <= 2 * The patient has a life expectancy of > 3 months. * Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study * Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment. * The patient has adequate organ and marrow function as follows: * ANC >= 1500 mm3, platelets >= 100,000/mm3, hemoglobin >= 9 g/dL, * serum creatinine <=1.8 mg/dL or creatinine clearance > 50 mL/min (Appendix I); * bilirubin <= 1.5 mg/dL; alanine aminotransferase (ALT), aspartate transaminase (AST) <= 2.5 times the upper limit of normal if no liver involvement or <= 5 times the upper limit of normal with liver involvement. * The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed). * The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits. * The patient is capable of understanding and complying with the protocol and has signed the informed consent document. Exclusion Criteria: * The patient has uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * The patient has active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV) * The patient has received chemotherapy or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug. * The patient has received radiation to >= 25% of his or her bone marrow within 4 weeks of the first dose of study drug. * The patient has received an investigational drug within 30 days of the first dose of study drug. * The patient has not recovered to grade <= 1 adverse events (AEs) due to investigational drugs or other medications, administered more than 2 weeks prior to the first dose of study drug, with the exception of neurotoxicity attributed to oxaliplatin or taxanes, which must have recovered to < 2 prior to study initiation. * The patient is pregnant or lactating. * The patient is known to be positive for the human immunodeficiency virus (HIV). The effect of BPM31510 on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study. * The patient has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee. * The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids. * The patient is receiving colony stimulating factors (CSFs) that cannot be held during the monitoring period for dose-limiting toxicities (DLT). * The patient has uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding. * The patient has a known predisposition for bleeding such as von Willebrand's disease or other such condition. * The patient requires therapeutic doses of any anticoagulant, including LMWH. Concomitant use of warfarin, even at prophylactic doses, is prohibited. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01957735

{ "NCT_ID" : "NCT01442285", "Brief_Title" : "The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)", "Official_title" : "The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)", "Conditions" : ["Cancer", "Distress"], "Interventions" : ["Behavioral: personalized, motivational messages"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to understand more about meeting the psychosocial needs of people who have cancer. Detailed Description The investigators are interested in the feasibility of using computer assisted screening and assessment to meet the psychosocial needs of people with cancer. The investigators are studying two different interventions. Both groups will receive health information, referral information, and resources. One group will also receive tailored feedback reports. #Intervention - BEHAVIORAL : personalized, motivational messages - A Healthcare Provider Report will be printed after each assessment and reviewed by the subject's oncologist. If any mental health functioning scale scores fall in the elevated or high range, a treatment plan will be constructed. Subjects will receive a personalized Patient Feedback Report after each assessment which will include motivationally tailored messages and suggestions for action. - Other Names : - motivational counseling

#Eligibility Criteria: Inclusion Criteria: * cancer diagnosis Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01442285

{ "NCT_ID" : "NCT02939300", "Brief_Title" : "Ipilimumab and Nivolumab in Leptomeningeal Metastases", "Official_title" : "Phase II Trial of Ipilimumab and Nivolumab in Leptomeningeal Metastases", "Conditions" : ["Leptomeningeal Carcinomatosis"], "Interventions" : ["Drug: Ipilimumab", "Drug: Nivolumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This research study is studying a combination of two drugs as a possible treatment for Leptomeningeal Metastases. The names of the study interventions involved in this study are: * Ipilimumab * Nivolumab Detailed Description This research study is a Phase II clinical trial. Researchers hope to study the effects of the combination of Nivolumab and Ipilimumab. Many cancers use specific pathways, such as programmed death-1 (PD-1), programmed death-ligand-1 (PD-L1), and cytotoxic T lymphocyte antigen-4 (CTLA-4), to evade the body's immune system. Nivolumab and ipilimumab work by blocking the PD-1/PD-L1 and CTLA-4 pathways and thus releasing the brakes on the immune system so it can stop or slow cancer. The FDA (the U.S. Food and Drug Administration) has approved Nivolumab and Ipilimumab as a treatment option for melanoma, but has not approved them for use when cancer cells spread to the cerebrospinal fluid #Intervention - DRUG : Nivolumab - * Melanoma: - Combination therapy with Nivolumab 1 mg/kg for 4 doses followed by monotherapy Nivolumab 480 mg per cycle. * Non-small Cell Lung Cancer / Head and Neck Cancer: - Combination therapy with Nivolumab 3 mg/kg * Small Cell Lung Cancer / Breast Cancer / Bladder Cancer: - Combination therapy with Nivolumab 1 mg/kg for 4 doses followed by monotherapy Nivolumab 240 mg per cycle. * Renal Cell Carcinoma / Other Solid Tumors (not listed above): * Combination therapy with Nivolumab 3 mg/kg for 4 doses followed by monotherapy Nivolumab 480 mg per cycle. - Other Names : - Opdivo - DRUG : Ipilimumab - * Non-small Cell Lung Cancer / Head and Neck Cancer: - Combination therapy with Ipilimumab 1 mg/kg * Small Cell Lung Cancer / Breast Cancer / Bladder Cancer: - Combination therapy with Ipilimumab 3 mg/kg for 4 doses * Renal Cell Carcinoma / Other Solid Tumors (not listed above): * Combination therapy with Ipilimumab 3 mg/kg for 4 doses - Other Names : - Yervoy

#Eligibility Criteria: Inclusion Criteria: * Participants must have histologically or cytologically confirmed disease from any solid tumor * Age >=18 years. * Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Karnofsky >=60%) * Life expectancy of greater than 3 weeks * Participants must have normal organ and marrow function as defined below, all screening labs should be performed within 10 days of treatment initiation. Adequate Organ Function Laboratory Values: Unit key: mcL = microliter, ULN = upper limit normal * Hematological * Absolute neutrophil count (ANC) >=1500 /mcL * Platelets >=100,000 / mcL * Hemoglobin >=9 g/dL or >=5.6 mmol/L without transfusion or Erythropoietin (EPO) dependency (within 7 days of assessment) * Renal * Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <= Serum creatinine <= 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula below): * Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL * Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL * Hepatic * Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN * Aspartate transaminase (AST) and Alanine transaminase (ALT) <= 3 ULN OR <= 5 X ULN for subjects with liver metastases * Albumin >= 2.5 mg/dL * Coagulation * International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Creatinine clearance should be calculated per institutional standard. * Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for Nivolumab to undergo five half-lives) after the last dose of investigational drug. * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of Nivolumab * Women must not be breastfeeding * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential, ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception * Ability to understand and the willingness to sign a written informed consent document. * Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment * Carcinomatous meningitis, as defined by positive cytology Exclusion Criteria: * Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier. Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Participants who are receiving any other investigational agents. * Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger * Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted. * As there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen. * Patients should be excluded if they have had prior systemic treatment with an anti-CTLA4 antibody * Has a known history of active TB (Bacillus Tuberculosis) * Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection * Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known history of, or any evidence of active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy. * Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. * History of allergy to study drug components * History of severe hypersensitivity reaction to any monoclonal antibody Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02939300

{ "NCT_ID" : "NCT02834364", "Brief_Title" : "BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)", "Official_title" : "LGX818 in Combination With MEK162 in Refractory or Relapsed Multiple Myeloma Patients With BRAFV600E or BRAFV600K Mutation", "Conditions" : ["Relapsed or Refractory Multiple Myeloma", "Patients With BRAFV600 E or BRAFV600K Mutation"], "Interventions" : ["Drug: Binimetinib", "Drug: Encorafenib"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Trial for patients with refractory multiple myeloma after failure of at least two treatment regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162). Detailed Description An open-label, single-arm, multi-centre phase II trial for patients with refractory multiple myeloma and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162). The patients must have received at least two prior therapy regimen (at least one immunomodulatory drug and one proteasome inhibitor). The subjects receive LGX 818 450 mg. p.o. once daily and MEK 162 45 mg p.o. twice daily until disease progression or toxicity requiring discontinuation of treatment. 1 cycle is defined as 28 days. #Intervention - DRUG : Encorafenib - 450 mg p.o. once daily. One cycle is defined as 28 days - Other Names : - LGX818 - DRUG : Binimetinib - 45 mg p.o. twice daily. One cycle is defined as 28 days - Other Names : - MEK162

#Eligibility Criteria: Inclusion Criteria: * Patient has provided a signed study Informed Consent Form prior to any study-specific procedure and is able to comply with protocol requirements * Patients with multiple myeloma,relapsed or refractory after failure of two or more lines of systemic treatments. All patients must have received at least one immunomodulatory drug (IMiD) and a proteasome inhibitor. Multiple myeloma requiring systemic therapy must have been confirmed in the medical history of the patients with criteria established by the International Myeloma Working Group (IMWG) (Rajkumar V et al. Lancet International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet 2014; 15: 538 <= age <= 548) * Written confirmation of BRAFV600E mutation or BRAFV600K mutation in in the majority of myeloma cells, defined by positive IHC staining with mutations specific antibody of >= 50% in the respective biopsy, confirmed by DNA sequencing of the corresponding codon * Measurable disease, as defined as: Measurable levels of myeloma paraprotein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24 hours) or FLC of involved light chain > 100mg/l and abnormal FLC-ratio * Age >=18 * WHO performance status 0 <= age <= 3 (WHO 3 is allowed only when caused by MM and not by comorbid conditions) (see Appendix 3) * Negative pregnancy test within 72 hours of inclusion (women of childbearing potential): For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy (see also exclusion criteria). * All patients must agree to abstain from donating blood while on study * Adequate cardiac function: left ventricular ejection fraction (LVEF) >= 50% as determined by an echocardiogram, QTc interval <= 450 ms * Ability of subject to take oral medications * Ability of subject to understand character and individual consequences of clinical trial Exclusion Criteria: * Patient with prior treatment with MEK and/or RAF inhibitors * Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow) * Patients with meningeosis or central nervous system lesion(s) caused by multiple myeloma. However, patients treated with stereotactic radiotherapy or surgery are eligible if patient remained without evidence of CNS disease progression >= 4 weeks. * History or current evidence of retinal vein occlusion (RVO) or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) * History of retinal degenerative disease * Plasma cell leukaemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2/nl. * Patient has received radiotherapy (including therapeutic radioisotopes) <= 21 days, if not restricted to a single osteolytic lesion, or has not recovered from side effects of such therapy. * Patient has had major surgery within 21 days prior to starting study drug or has not recovered from major side effects of the surgery. Kyphoplasty as prevention of skeletal related events is allowed. * Patient is concurrently using other approved antineoplastic or any investigational agents in the last 14 days prior to start of treatment. Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 4 weeks prior to study entry. * Impaired cardiovascular function or clinical significant cardiovascular disease including any of the following: Symptomatic chronic heart failure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality <6 months prior to Screening except atrial fibrillation and paroxysmal supraventricular tachycardia; 1. LVEF < 50% as determined by ECHO, or uncontrolled hypertension despite medical treatment (please refer to WHO ISH guidelines) 2. Clinically significant resting bradycardia, unstable angina pectoris <= 3 months prior to starting study drug, history of acute coronary syndromes (including myocardial infarction, coronary artery bypass grafting, coronary angioplasty, or stenting) <6 months prior to screening 3. QTcF > 450 msec 4. patients with acute diffuse infiltrative pulmonary and pericardial disease * Significant hepatic dysfunction (serum bilirubin >= 2 mg/dl or ASAT and/or ALAT >= 2.5 times normal level), unless related to myeloma * Active hepatitis B, and/or active hepatitis C infection * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818/MEK162 (e.g., ulcerative diseases, uncontrolled nausea,vomiting, diarrhea, malabsorption syndrome, small bowel resection). * Gilbert´s syndrome * Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) * Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment. Note: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment * Patients known to be HIV-positive * Patients with active, uncontrolled infections (patients successful treated with antimicrobial therapy may be enrolled at the discretion of the investigator). * Patient is receiving chronic treatment with systemic steroids or another immuno-suppressive agent at start of study treatment. Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) and the use of systemic steroids up to a prednisone equivalent of 10 mg daily are allowed. * Patient has consumed Seville oranges, grapefruit, grapefruit hybrids, pomelos and exotic citrus fruits (as well as their juices) during the last 7 days prior to start of treatment. Regular orange juice is permitted. * Second malignancy within the past 3 years except: 1. Adequately treated basal cell or squamous cell skin cancer (adequate wound healing is required prior to entry in the study) 2. Adequately treated carcinoma in situ of the cervix, 3. Prostate Cancer not requiring systemic treatment or under anti-hormonal treatment and PSA-level below upper level of normal range. 4. Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), 5. solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry 6. Similar condition with an expectation of > 95 % 5-year disease free survival * Patients with any of the following laboratory values at Screening/Baseline. 1. Absolute neutrophil count (ANC) <1,000/mm3 [1.0 x 109/L] without Growth factor support in the last 7 days 2. Platelets <= 50000/mm3 [50 x 109/L] ; patients with platelets 75000- 50000/ mm3 are eligible if thrombocytopenia is confirmed as related to myeloma bone marrow infiltration and pt. is able to receive thrombocyte concentrates 3. Hemoglobin < 8.0 g/ dl (unless confirmed related to myeloma bone marrow infiltration and pt. able to receive blood transfusions) 4. Serum creatinine >2 x ULN or calculated or directly measured CrCl <= 45 ml/min; patients with creatinin-clearance between 30 <= age <= 45 ml/min can be enrolled with approval by the coordinating investigator. * Clinically significant autoimmune haemolytic anaemia with positive Coombs test or immune thrombocytopenia * Patient is a woman of child-bearing potential, UNLESS they are using a double barrier method for birth control throughout the trial. 1. Hormonal contraceptives may be affected by cytochrome P450 interactions, and are therefore considered neither indicated nor effective. 2. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper), sponge or spermicide. 3. Reliable contraception has to be maintained throughout the study and for 12 weeks after study drug discontinuation. 4. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential * Sexually active males unless they agree to use a condom during intercourse while taking the drug. This practice should be continued for another 12 weeks after stopping treatment. Also they should not father a child during the study period or the 12 weeks post study time. A condom is also required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid; * Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study. * Patients taking non-topical medication known to be a strong inhibitor of CYP3A4. However patients who either discontinue their treatment or switch to another medication at least three days prior to registration are eligible. * Participation in other clinical trials within 1 month prior to enrolment except patients for supportive care studies and vaccination studies. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months. * Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g. uncontrolled diabetes, chronic pancreatitis, active chronic hepatitis ). No subject will be allowed to be enrolled in this trial more than once. * Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02834364

{ "NCT_ID" : "NCT00412503", "Brief_Title" : "Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents", "Official_title" : "Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents", "Conditions" : ["Refractory Tumors", "Malignant Tumors"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination. #Intervention - DRUG : Topotecan, Temozolomide

#Eligibility Criteria: Inclusion Criteria: * histologically documented malignant tumor * refractory or relapsing after conventional treatments and for which there is no curative treatment available * life expectancy > 8 weeks * no significant co-morbidity (NCI-CTC < 2) * No organ toxicity * no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy Exclusion Criteria: * Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds * Hypersensibility to Dacarbazine (DTIC) * Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase Sex : ALL Ages : - Minimum Age : 6 Months - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00412503

{ "NCT_ID" : "NCT01740323", "Brief_Title" : "Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy", "Official_title" : "Meriva for Treatment-induced Inflammation and Fatigue in Women With Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Placebo", "Drug: Curcumin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer after having completed chemotherapy. Patients who have received prior chemotherapy will be eligible, because we have found that this enriched population is at particular risk for exhibiting increased NF-kB DNA binding and IL-6 following XRT. Detailed Description As many as 60% of breast cancer (BrCA) patients receiving radiation are known to develop fatigue with about 30% suffering persistent fatigue several months to years after treatment completion (12-23). The physical, psychological, and molecular mechanisms by which patients develop fatigue are poorly understood and most likely multi-factorial. One pathway that has received considerable attention is nuclear factor-kappa B (NF-kB)(24). The NF-kB pathway has emerged as having an important role not only in cancer treatment resistance but in the development of fatigue. NF-kB activation leads to over expression of interleukin (IL)-1beta, IL-6, and tumor necrosis factor (TNF)-alpha, all factors related to inflammation and factors that have been found to be upregulated in patients receiving radiation as well as BrCA survivors with fatigue (25-29). A recently published study looking at TNF-alpha, fatigue and cachexia in cancer patients receiving docetaxol showed that NF-kB is upregulated in fatigued patients and that agents which inhibit TNF-alpha lead to better tolerance of chemotherapy dose escalation (30). Work by our group and others has shown that ionizing radiation increases NF-kB pathway activity in circulating immune cells (as well as within breast cancer cells) and that this effect is most pronounced in women previously treated with chemotherapy (31, 32). Our work has shown that the NF-kB pathway activity in circulating immune cells is also related to fatigue development in BrCA patients treated with radiation and that patients most at risk for persistent fatigue and NF-kB pathway activity are those who have received chemotherapy for their breast cancer (31). Curcumin, a known inhibitor of NF-kB, has been shown to decrease NF-kB activation in human participants. In a recent study, 8 grams of curcumin by mouth daily for 8 weeks was well tolerated in patients with pancreatic cancer and other pre-malignant conditions with no associated toxicities (6, 8). Although there is concern over the body's absorption of curcumin, the bioavailability of curcumin in the study of pancreatic cancer patients was shown, with peak drug levels at 22 to 41ng/mL that remained relatively constant over the first 4 weeks of treatment with 8 grams of curcumin daily (8). Clinical trials with daily dosages of 1,125 to 2,500mg have also confirmed the safety of curcumin and also shown its ability to decrease inflammation in patients with rheumatoid arthritis and in post-operative patients (6, 33, 34). In vivo murine models of chronic fatigue syndrome have also shown that curcumin may also alleviate symptoms of fatigue (35). While these studies are promising, very little is known about the capacity of Meriva to inhibit NF-kB in women treated for BrCA. We hypothesize that oral Meriva, a known inhibitor of NF-kB, may be used to decrease levels of NF-kB activity in BrCA patients previously treated with chemotherapy who go on to receive radiotherapy (XRT), a carefully chosen group of patients at particular risk for high levels of NF-kB DNA binding (a direct measure of NF-kB pathway activity). We have chosen to administer oral Meriva, 500mg BID, in our patient population based on the above data. Meriva-500 is a curcumin formulation that also contains phosphatidylcholine, derived from soy that has been shown to aid in absorption of curcumin (9), permitting a lower overall dose of curcumin. Of note, 1000 mg Meriva contains 200 mg curcuminoids (\>90% curcumin). By decreasing activity of NF-kB and ultimately plasma IL-6, fatigue may improve in BrCA patients taking Meriva. Results from this study will contribute to the limited research available on the capacity of curcumin treatment, including Meriva, to inhibit NF-kB activation in vivo as well as symptoms of fatigue associated with excessive NF-kB pathway activity in BRCA patients. #Intervention - DRUG : Placebo - daily placebo for 6 weeks - DRUG : Curcumin - 500 mg BID - Other Names : - Meriva

#Eligibility Criteria: Inclusion Criteria: * Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT. Exclusion Criteria: * Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01740323

{ "NCT_ID" : "NCT04055142", "Brief_Title" : "Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males", "Official_title" : "A Phase III, Randomized, One-site, Pilot, Open-label, Parallel Groups Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males", "Conditions" : ["High-grade Anal Intraepithelial Neoplasia"], "Interventions" : ["Drug: sinecatechins 10% topical ointment", "Drug: cidofovir 1% topical ointment", "Procedure: electrocoagulation"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN). The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males. All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group. Detailed Description This Trial addresses one of the emerging problems in patients with HIV infection, such as the high incidence of anal dysplasia and anal cancer. The study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost). Topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. This makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation. On the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. Finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease. #Intervention - PROCEDURE : electrocoagulation - HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks) - DRUG : cidofovir 1% topical ointment - HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks) - Other Names : - Cidofovir - DRUG : sinecatechins 10% topical ointment - HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks) - Other Names : - Veregen ointment

#Eligibility Criteria: Inclusion Criteria: * Men who have sex with men, older or same than 18 years. * HIV-1 positive men. * High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study. * Informed consent is signed voluntarily. Exclusion Criteria: * Patient with any disease or condition which rules him out to participate in the research, by investigator opinion. * Treated patients for HGAIN in the previous 6 months. * Patients with relapsed HGAIN two or more times in the last three months. * People with learning difficulties Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04055142

{ "NCT_ID" : "NCT00116441", "Brief_Title" : "Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma", "Official_title" : "Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line", "Conditions" : ["Multiple Myeloma"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line. #Intervention - BIOLOGICAL : Therapeutic Cellular Vaccine, GM-CSF Producing

#Eligibility Criteria: Inclusion Criteria: * De novo multiple myeloma * ECOG 0 <= age <= 2 * No serious co-morbid illnesses and adequate organ function * > 4 weeks from systemic steroids Exclusion Criteria: * No existing secondary malignancies and no history of secondary malignancies in the past 5 years * No active autoimmune disease Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00116441

{ "NCT_ID" : "NCT04232059", "Brief_Title" : "The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery", "Official_title" : "The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery: Randomized Controlled Cross Over Study", "Conditions" : ["Infratentorial Neoplasms", "Hyperventilation", "Craniotomy"], "Interventions" : ["Device: cerebral oximetry"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The aim of this study is to evaluate the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection. Detailed Description Introduction: Hyperventilation has been used for intraoperative brain relaxation for decades, Interestingly, this common practice is not based on robust evidence . The mechanism of brain relaxation secondary to hyperventilation is attributed to the hypocapnia induced cerebral vasoconstriction and the subsequent reduction of cerebral blood volume (CBV) and intracranial volume. The CBV reduction is accompanied by the reduction in cerebral blood flow that could render the brain at ischemic risk, if the cerebral metabolic activity remains the same before and after hyperventilation. So, it is possible that inadvertent cerebral ischemia may outweigh the benefits of hyperventilation and should be subjected for further investigation. Cerebral near-infrared spectroscopy (NIRS) is a useful non-invasive tool for regional cerebral oxygen saturation (rScO2) monitoring, which provides continuous, real time information on the balance between cerebral oxygen delivery and consumption. Cerebral oximetry monitoring had the ability to detect clinically silent episodes of cerebral ischemia in a variety of clinical settings which could be an important safeguard for cerebral function. Hyperventilation had been shown to significantly reduce cerebral oxygenation using near-infrared spectroscopy in patients undergoing elective abdominal surgery. Multiple studies have shown that prolonged hyperventilation correlated with poor outcome especially in brain injured patients. 5,6 However, there is still a lack of evidence on the relationship between hyperventilation and neurological outcome in patients having craniotomy. However, to the best of the investigator's knowledge no previous randomized controlled trials had studied the effect of hyperventilation versus normo-ventilation on cerebral oximetry in pediatrics undergoing posterior fossa tumor surgeries. V. Study procedure: This is a prospective, randomized controlled trial with a two-period crossover design so that the patient can act as a control to himself. Enrolled patients are children (1-6 years old) undergoing posterior fossa tumor resection. Prior to anesthetic induction, the two sensors (SAFB-SM, Covidien, Dublin, Ireland) for near-infrared spectroscopy (INVOS 5100C, Covidien, Dublin, Ireland) will be applied on the left and right sides of the forehead with the caudal border approximately 1 cm above the eyebrows to measure regional oxygen saturation (rSO2). A bispectral index (BIS) sensor will also be fixed on the left forehead (Model QUATRO, Covidien, Dublin, Ireland) to monitor the depth of anesthesia. Both sensors will be fixed to their positions using adhesive pads to avoid removal during positioning and soaking with betadine solution. Baseline values for cerebral oxygen saturation will be obtained using NIRS monitor, Standard monitors (electrocardiogram, non-invasive blood pressure, pulse oximeter) will be applied to all patients. The anesthetic management will be standardized for all patients as follows: General anesthesia will be induced by inhalational agent 'sevoflurane' until intravenous line is secured then Fentanyl (1-2 µg/kg), Propofol (1-2 mg/Kg) will be given intravenously. Intubation will be facilitated by Atracurium (0.5 mg/kg) and confirmed by capnography. Nasopharyngeal temperature probe will be inserted for monitoring of core body temperature which will be kept between 36.5-37 C using warming blankets. A 22 G arterial cannula will be placed in the left radial artery and baseline ABG will be obtained to correlate value of Etco2 and Paco2. Anesthesia will be maintained with isoflurane in oxygen 40% and will be adjusted to maintain BIS between 40 and 60 and Atracurium infusion (0.5 mg/kg/hr). Central venous line will be inserted in the right internal jugular vein under complete aseptic condition under ultrasound guidance, wide bore peripheral cannula will be inserted for fluid management and a Foley's catheter will be inserted in the urinary bladder for urine output monitoring. Patients will be positioned in the prone position with the arms positioned and secured at the patient's side and after careful padding of the pressure points; the patient head will be supported on the forehead using a horseshoe adapter. Slight neck flection will be permitted till the anesthetist can pass two fingers easily between the chin and the chest to allow for optimum surgical exposure. Patients will be randomly assigned using concealed envelopes, according to a computer-generated random number to one of the following two treatment sequences: * Group 1: hyperventilation (ETco2 25-30 mm Hg) for 20 minutes that will start immediately after skin incision followed by normoventilation (ETco2 31-35 mm Hg) for another 20 minutes. * Group 2: normoventilation (ETco2 31-35 mm Hg) for 20 minutes immediately after skin incision followed by hyperventilation (ETco2 25-30 mm Hg) for another 20 minutes. The ventilation strategies will be achieved using volume-controlled mode with a tidal volume of 8 ml/kg, I/E ratio:1/2 and ETco2 will be maintained at the desired range by adjusting the respiratory rate. Positive end-expiratory pressure (PEEP) will not be applied. After removal of the bone flap and exposure of the dura matter, a 20-gauge plastic cannula will be inserted into the subdural space along the surface of the brain. This will be connected to a calibrated pressure transducer via a length of polyethylene high pressure tubing filled with normal saline. The transducer will be zeroed at ear level. During the study period, the mean subdural pressure will be recorded at 2 minutes intervals at the end expiratory phase. Assessment phase 1: An arterial blood sample will be obtained immediately after skin incision for blood gas analysis to determine the difference between arterial and end-tidal carbon dioxide tension (Pa-ETCO2). Ventilation and ETCO2 will be kept constant for at least 20 min, which is long enough for stabilization of any vascular responses to the change in Paco2. At the end of the equilibration period (20 minutes), another arterial blood sample will be obtained to confirm that the targeted Paco2 (was achieved. The neurosurgeon, unaware of the anesthetic and ventilatory management provided, will be then asked to score the brain bulk according to a four-point scale as follows: 1. Excellent with no swelling 2. Minimal swelling, acceptable 3. Swollen but no treatment required 4. Swollen, needing treatment. After this assessment, ventilation will be changed immediately according to group assignment. Assessment phase 2: Another 20 min of equilibration will be allowed and measurements will be repeated as previously described. During the whole period of study (40 minutes), the cerebral oximetry will be recorded at 5 minutes intervals. During this period factors that may affect cerebral oximeter will be controlled by maintaining position of the patient head, (normothermia with temperature at 36.5-37 C), within 20% of the base line blood pressure using increments of ringer solution and ephedrine boluses as appropriate, maintain PH 7.35-7.45, Hb level around 10 gm/dl guided by blood loss and repeated measurements of Hb in ABG and blood glucose level between 80-180 mg/dl. The study will be ended at this point, the subdural cannula will be removed, and surgery will proceed as normal. Specific or routine interventions for brain swelling such as a change in body position or diuretic therapy with mannitol or furosemide will not be administered until the study had ended. However, for ethical reasons, interventions will be made if requested by the surgeon and the patient will be then withdrawn from the study. Data will be collected by an independent blinded anesthesiologist using a data collection form. • Measurement tools: * Demographic and categorical characteristics including patient's age in years, weight in Kg, gender, type of the procedure( 4th ventricular, medulloblastoma,... ) * Both NIRS values at baseline and every 5 minutes during each phase of the study * Subdural intracranial pressure (ICP) every 2 minutes during each phase of the study * End tidal co2 every 5 minutes during each phase of the study * Paco2 baseline and at the end of each phase of ventilation (20 minutes following start of phase 1 assessment and 20 minutes after start of phase 2 assessment) * Heart rate and mean arterial blood pressure every 10 minutes. * Brain relaxation score #Intervention - DEVICE : cerebral oximetry - evaluation of the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.

#Eligibility Criteria: Inclusion Criteria: * Age : 1 <= age <= 6 old * Both sexes * ASA I-II * scheduled for posterior fossa tumor resection. Exclusion Criteria: * Age < 1 year or > 6 years * Comorbid condition (ASA classification > II) * patient with anemia (Hb <10 g/dl) * Emergency surgery * Patients with VP shunt, on diuretics, recurrent tumors, cerebral infarction and or hemorrhage * Patients on cardiovascular support e.g.:, inotrope or vasoconstrictor infusions Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 6 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT04232059

{ "NCT_ID" : "NCT03167762", "Brief_Title" : "Photographing the Skin During Photodynamic Therapy", "Official_title" : "Fluorescence and Thermal Imaging of the Skin Before and During Photodynamic Therapy", "Conditions" : ["Basal Cell Carcinoma", "Bowen's Disease"], "Interventions" : ["Device: Fluorescence and thermal imaging"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent, meaning that it produces red light when blue light is shone on it. By measuring how much light is given off with a camera, the investigators can determine how much photosensitiser is present in the skin. Also, it is thought that more of the chemical is converted to the active photosensitiser if the skin is warmer, so the investigators plan to measure the temperature of the skin using a thermal camera. Light is shone on to the skin and this activates the photosensitiser, treating the problem area and leaving healthy skin intact. This research will increase the investigators understanding of how PDT works, and may help the investigators to improve treatment regimens so that they can be made more effective and better tolerated #Intervention - DEVICE : Fluorescence and thermal imaging - Two cameras used to take images of the skin. One, to measure the fluorescence from the photosensitiser, and the second to measure the surface temperature of the skin

#Eligibility Criteria: Inclusion Criteria: * 1. Patients presenting with superficial BCC or Bowen's disease (one or two lesions and diagnosed either clinically or histologically and untreated or having had no treatment for 4 months or longer) 2. Adult males and females, >18 years only 3. Capable of giving informed consent 4. Able to understand and adhere to protocol requirements Exclusion Criteria: * 1. Patients skin lesions have had previous treatment in the last 4 months 2. Unable to give informed consent 3. Known allergy to Metvix® 4. Known to have a light sensitive disorder 5. Pregnant, breastfeeding or planning to conceive Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03167762

{ "NCT_ID" : "NCT03183765", "Brief_Title" : "Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts", "Official_title" : "Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts : a Randomized Controlled Trial", "Conditions" : ["Common Wart", "Plantar Wart"], "Interventions" : ["Procedure: cryotherapy", "Drug: Measles-Mumps-Rubella Vaccine"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct person-to-person contact or indirectly by fomites . Warts appear in various forms including verruca vulgaris, plane, plantar, filiform, digitate and periungual. Detailed Description Treatment of warts is difficult for patients and physicians . Currently Available treatment options include cryosurgery, laser, electrosurgery, bleomycin, and topical keratolytic applications; many of them are painful, ineffective, costly and prone for recurrences. Cryotherapy, which uses liquid nitrogen to freeze tissues and destroy warts, is one of the most common and effective treatments. freezing causes local irritation, leading the host to mount an immune reaction against the virus. Immunotherapy appears to enhance virus recognition by immune system; allowing clearance of treated wart, distant warts , and helps to prevent infection .Recently, intralesional immunotherapy using different antigens such as mumps, Candida, and tuberculin has been proved effective in the treatment of warts. The exact mechanism of action of intralesional immunotherapy is still obscure. Intralesional antigen injection probably induces strong non specific inflammatory response against the human papilloma virus-infected cells. It has been suggested that intralesional measles mumps rubella vaccine results in regression of warts via induction of immune system. #Intervention - DRUG : Measles-Mumps-Rubella Vaccine - MMR vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments. Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\\or a decrease in the total number of warts), and no response (no change in size and number of warts). - Other Names : - MMR - PROCEDURE : cryotherapy - patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions.Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\\or a decrease in the total number of warts), and no response (no change in size and number of warts).

#Eligibility Criteria: Inclusion Criteria: * Patients should have multiple common or plantar warts. * No concurrent systemic or topical treatment of warts Exclusion Criteria: * patients under 16 years. * Patients with fever or signs of any inflammation or infection. * Patients with other types of warts. * Patients with single warts. * Pregnancy. * Lactation. * Immunosuppression. * Patients who received any other treatments for their warts in the month before starting study. * Past history of asthma, allergic skin disorders, meningitis or convulsions. Sex : ALL Ages : - Minimum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT03183765

{ "NCT_ID" : "NCT01983592", "Brief_Title" : "An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy", "Official_title" : "An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy", "Conditions" : ["Fatigue", "Effects of Chemotherapy"], "Interventions" : ["Other: Unmedicated lactose/sucrose globule", "Other: Homeopathic medicine"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients and there are very few conventional therapies which can address the symptom of fatigue in patients who are undergoing cancer treatment. This study will be testing whether the administration of a complementary therapy (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and whether this treatment can lessen the fatigue symptoms of adults. The study will also test whether the n-of-1 study design is feasible in this population. Detailed Description This is an n-of-1 pilot trial of individualized homeopathic treatment of fatigue in a single adult who is undergoing any type of chemotherapy administered intermittently (i.e. not continuously). The participant will have a homeopathic consultation within 3 days of a round of chemotherapy ('treatment period') and will be administered either verum or placebo according to a binary randomization allocation sequence unknown to both the clinician and participant. During the subsequent treatment period the participant will be given the other allocation (verum or placebo). The following pairs of allocations will also be randomized with treatment continuing for as long as the participant is undergoing chemotherapy treatment. #Intervention - OTHER : Homeopathic medicine - Intervention must begin within 5 days of chemotherapy cycle completion. Intervention will continue until the next cycle of chemotherapy. The initial consultation will involve a verbal interview between the homeopath and the participant. The practitioner will then choose a single homeopathic remedy that will focus on the reduction of fatigue. Only one homeopathic remedy and potency will be administered at a given time. The participant will be asked to take the study medication at least 30 minutes before or after taking other medications, food and strong smelling substances. - OTHER : Unmedicated lactose/sucrose globule

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with any type of cancer. Patient may have newly diagnosed, relapsed or a second malignant disease. * Receiving any type of cytotoxic chemotherapy with 6 or more cycles post study enrollment administered intermittently every two or three weeks with no planned radiation treatment. * Is experiencing fatigue due to the chemotherapy treatments. (or has a score of 2 or higher on the fatigue item of the Symptom Distress Scale) * Above 18 years. * Able to ingest medications in lactose/sucrose globule or liquid form. Exclusion Criteria: * Previous history of allergy to the homeopathic products. * Pregnant or lactating Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01983592

{ "NCT_ID" : "NCT00355472", "Brief_Title" : "Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL", "Official_title" : "Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)", "Conditions" : ["Adult T-Cell Leukemia and Lymphoma (ATL)", "Adult Peripheral T-Cell Lymphoma (PTCL)"], "Interventions" : ["Drug: KW-0761"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL). Detailed Description This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established. #Intervention - DRUG : KW-0761 - IV administration at 4 escalating dose levels.

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed diagnosis of a CCR4-positive ATL and PTCL that is any of the following: A. ATL (Adult T-Cell Leukemia-Lymphoma) * Seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody; * Acute, Lymphoma, or Chronic phase with high-risk factors (within 14 days before the study entry); B. PTCL (Peripheral T-Cell Lymphoma) * Includes Mycosis Fungoides and Sezary Syndrome; 2: Relapsed to the latest standard chemotherapy; 3: Received at least one prior chemotherapy; 4: After 4 weeks from a prior therapy; 5: Have measurable disease; 6:Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 7: Male or female, at least 20 years and not older than 70 years; 8: Signed written informed consent; 9: Stay in hospital for 4 weeks; 10: HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry); 11: Adequate bone marrow, hepatic and cardiac function including the followings: * Neutrophil count >= 1,500 /mm3, * Platelets >= 75,000 /mm3, * Hemoglobin >= 8.0 g/dL * Serum creatinine <= 1.5 x ULN; * Serum SGOT (AST) and SGPT (ALT) <= 2.5 x ULN (<= 5.0 x ULN if considered due to disease involvement in liver); * Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if considered due to disease involvement in liver) * Serum calcium <= 11.0 mg/dL * PaO2 >= 65 mmHg or SaO2 >= 90% * No clinically significant Electrocardiogram abnormality * Left Ventricular Ejection Fraction >= 50% [by ECHO or MUGA] Exclusion Criteria: * Co-existing active infection or any co-existing medical condition that may compromise the safety of patients during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results; * Active tuberculosis; * Prior stem cell transplantation; * Myocardial infarction (within 12 months prior to the study entry); * Concurrent acute or chronic hepatitis, or cirrhosis; * Anti-HCV: positive, Anti-HIV: positive * Concurrent active malignant disease; * Known allergic reaction to antibody therapy; * Concomitant treatment with systemic steroids; * Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases; * Evidence of CNS metastasis at baseline; * Prior and Concurrent spinal cord disease; * Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study; * Female patients who are pregnant or breast feeding; * Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards; * Treatment with any other investigational agent within the 4 months prior to study entry; * For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 69 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00355472

{ "NCT_ID" : "NCT03796819", "Brief_Title" : "Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma", "Official_title" : "Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma", "Conditions" : ["Intrahepatic Cholangiocarcinoma"], "Interventions" : ["Procedure: lymphadenectomy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains. Detailed Description Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform LND only in select circumstances. The utilization of LND may not only vary among different institutions, but also by geographic region. Specifically, data from East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While several case series from Asia have noted that most centers do not regularly perform LND,other data from the West suggest that LND may be becoming more routine. Despite the lack of consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual recommends that the nodal basin be staged. Disease-specific staging for ICC was first introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated 8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to stage a patient with ICC. The previous multi-institutional retrospective study from the investigators have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains. #Intervention - PROCEDURE : lymphadenectomy - Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection

#Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy * The tumor is limited in the liver with no distant metastasis, and the primary disease is resectable * Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found no nodal swelling or enlargement Exclusion Criteria: * The primary disease is unresectable with or without distant metastasis * The liver function or general condition of patients does not permit surgery * Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed * Patients aged below >= 18 years than 65 would be excluded * Pregnant women would not be enrolled Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03796819

{ "NCT_ID" : "NCT03001882", "Brief_Title" : "An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)", "Official_title" : "An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)", "Conditions" : ["Non-Small Cell Lung Cancer"], "Interventions" : ["Biological: Nivolumab", "Biological: Ipilimumab"], "Location_Countries" : ["Netherlands", "Belgium", "Italy", "Germany", "United States", "France", "Spain", "Romania"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). #Intervention - BIOLOGICAL : Nivolumab - Specified dose on specified days - Other Names : - Opdivo, BMS-936558 - BIOLOGICAL : Ipilimumab - Specified dose on specified days - Other Names : - Yervoy, BMS-734016

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease * Measurable disease by CT or MRI * Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work Exclusion Criteria: * Participants with untreated central nervous system metastases * Participants with active, known or suspected autoimmune disease * Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03001882

{ "NCT_ID" : "NCT01295632", "Brief_Title" : "Safety and Tolerability of Different Dose Combinations of Ridaforolimus With MK-2206 or MK-0752 for Participants With Advanced Cancer (MK-8669-049)", "Official_title" : "Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MK-MK) in Patients With Advanced Cancer", "Conditions" : ["Advanced Cancer"], "Interventions" : ["Drug: ridaforolimus", "Drug: MK-2206", "Drug: MK-0752"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752. In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug combinations will be found by giving sequentially higher doses of the study drugs. An expansion cohort of participants may be enrolled to confirm the MTD. New cohorts at other dose levels may be enrolled, depending on the rate of dose limiting toxicities (DLTs) in the planned cohorts. In Part B, an assessment of the efficacy of the drug combinations against selected advanced cancers will be made so that a recommended dose to be used in Phase 2 studies (RPTD) can be found. As of 19 July 2012 the MK-0752 arms of the study were fully enrolled and closed to further recruitment. As of 30 November 2012, no additional participants with prostate cancer will be enrolled. #Intervention - DRUG : ridaforolimus - 10 mg enteric-coated tablets, orally, starting dose 2 tablets and escalating to 4 tablets each day for 5 days per week. - Other Names : - MK-8669 - DRUG : MK-0752 - 300 mg capsule, orally, 6 capsules per dose, once each week. - DRUG : MK-2206 - Tablets (5 mg, 25 mg, and 200 mg) to equal starting dose of 90 mg and escalating to 200 mg per dose, orally, once each week.

#Eligibility Criteria: Inclusion Criteria: Part A of the Study: Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Non Hodgkin Lymphoma (NHL) participants (in Part A only), must have histologically confirmed relapsed/refractory NHL. There is no limit on the number of prior treatment regimens. Part B of the Study: * Participant must have performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Participant must have adequate organ function. * Participants must be willing to use effective methods of contraception. * Participant is able to swallow capsules and has no surgical or anatomical condition that will preclude the participant from swallowing and absorbing oral medications on an ongoing basis. * Participant has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with Prostate-Specific Antigen (PSA) <1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician. * Participant has at least one measurable recurrent or metastatic lesion (if a solitary lesion, histological/cytological confirmation of its neoplastic nature is required) with the exception of prostate cancer participants which do not require measurable disease if participant has PSA level of >10 ng/mL. * Participant must agree to provide archival or newly-obtained tumor tissue sample. * Ridaforolimus + MK-2206 Treatment Arm: * Participant must have a histologically-confirmed prostate cancer that is refractory to hormone therapy and for which the participant received any number of prior treatment regimens (no longer recruiting as of 30 November 2012), OR * Participant must have a histologically-confirmed breast cancer for which the participant received any number of prior treatment regimens. Archival or fresh tissue must demonstrate a low RAS-gene signature and a high Ki67 index label if estrogen receptor (ER)+ * Ridaforolimus + MK-0752 Treatment Arm: * Participant must have a histologically-confirmed recurrent (either primary or secondary) glioblastoma multiforme with radiographic evidence of progression/recurrence of disease, and up to 2 prior treatment regimens for their recurrent disease, and no prior treatment with bevacizumab, OR * Participants must have a histologically-confirmed relapsed or refractory ovarian cancer for which the participant received no more than 2 prior treatment regiments which was either relapsed or refractory to the first line treatment. Exclusion Criteria: * Participant has had chemotherapy or radiotherapy within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas, mitomycin C), biological therapy (excluding antibodies) within 2 weeks prior to study Day 1, or who has not recovered (<=Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier. Luteinizing-hormone releasing hormone (LHRH) use by prostate cancer patients is permitted; participants with prostate cancer previously treated with flutamide or nilutamide require 4 week washout period and participants previously treated with bicalutamide require 6 week washout period before study drug administration. * Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (not including monoclonal antibodies), whichever is longer, of Day 1 of this study. * Participants with known symptomatic or progressing Central Nervous System (CNS) metastases and/or carcinomatous meningitis are excluded. However, participants with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids. * Participant has known hypersensitivity to the components of study drug or its analogs. * Participant has prior exposure to agents that have the same target as to the study drug. * Participant has significant or uncontrolled cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a myocardial infarction within the last 6 months. * Participant is a known diabetic participant who is poorly controlled at screening. * Participant has known psychiatric or substance abuse disorders that would interfere with compliance with study requirements. * Participant is, at the time of signing informed consent, a regular user (including 'recreational use') of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse. * Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. * Participant is known to be Human Immunodeficiency Virus (HIV)-positive. * Participant has active Hepatitis B or C. * Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions is eligible. * Participant has a requirement for concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for >= 2 weeks prior to first planned dose of study drug. * Participant has a requirement for concurrent treatment with medication(s) that strongly or moderate induce or inhibit cytochrome P450 (CYP3A). Participants should be off these medications >= 2 weeks prior to the first dose of study medication. * For participants with glioblastoma, dexamethasone should be discontinued at least 1 week prior to the first dose of study drugs. For participants on the Ridaforolimus + MK-0752 treatment arm: * Participant requires or anticipated to require concomitant therapy with enzyme-inducing antiepileptic therapy. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01295632

{ "NCT_ID" : "NCT00836186", "Brief_Title" : "Cytokine Expression During Radiation for Breast Cancer", "Official_title" : "Cytokine Expression During Radiation for Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Radiation: Radiation therapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To assess the magnitude and frequency of changes in chemo/cytokine expression in women receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer. And finally to assess the interaction between radiation-induced chemo/cytokine expression changes, and race/ethnicity, with respect to normal tissue reactions to radiation and tumor-associated outcomes. Detailed Description It is well recognized that the diagnostic and therapeutic gains made in the management of breast cancer over the last 2 decades are not fully realized by all groups. African American women with breast cancer have greater risk of recurrence, shorter overall survival, shorter survival after relapse, worse toxicity and worse cosmetic outcome than their Caucasian counterparts. These differences in outcome persist even when controlling for age, and stage at presentation. Being similarly treated with modern breast conserving therapy (lumpectomy and adjuvant whole breast irradiation) at recognized centers of excellence does little to alleviate the disparities in outcomes. Controlling for socioeconomic factors decreases the severity of these disparities, but it does not completely explain them. Theories abound as to the cause of outcome inequality. Many of these theories take either a psychosocial, or biologic bent. One potential biologic cause may be chemokine and cytokine expression. Chemokines and cytokines (chemo/cytokines) are proteins and peptides used for cell signaling. Primarily secreted by T cells and macrophages, they influence cellular activation, differentiation, and function and act as mediators for inflammatory and immune responses. There has been substantial research linking some of these chemo/cytokines \[Tumor necrosis factor alpha (TNFα), platelet derived growth factor (PDGF), Transforming growth factor beta (TGFβ), interleukin (IL)-6,and IL-8\] to tumor promotion and progression. For example, TNFα has been linked to greater cell survival despite genomic injury which in turn leads to greater genetic alterations and malignant transformation. TNFα has been associated with breast cancer progression and metastases. Blocking the receptor for PDGF appears to decrease the metastatic potential of breast cancer cell lines. TGFβ inhibits T cell and B cell lymphocytes and natural killer cell cytotoxicity. This immuno-suppression has been shown to promote tumor progression in mammary cancer cells lines. The ability of TGFβ to promote tumor progression is so well recognized that it has become a therapeutic target by some researchers. Interferon gamma (IFNγ) has been shown to inhibit mammary cancer cell proliferation and angiogenesis in vitro and in vivo. Clinically, Lyon et al reported significantly higher circulating levels of TNFα, IL-6, and IL-8 in women with breast cancer compared to women with a negative breast biopsy. Additionally, researchers have directly correlated increased levels of IL-6 with the development and progression of breast cancer, and decreased overall survival (OAS). Conclusion: Expression of certain chemokines and cytokines is associated with development and progression of breast cancer. #Intervention - RADIATION : Radiation therapy - Patients will receive whole breast radiation therapy at a dose of 180-200 centigray (cGy) per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.

#Eligibility Criteria: INCLUSION CRITERIA: * Patient must be 18 years or older * Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast any T, any N, M0 disease * Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved. * Patients must be registered such that radiation therapy begins within 10 weeks of last surgery * Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80 <= age <= 100 Karnofsky Performance Scale at time of consult * Women of all races and ethnic groups are eligible for this trial EXCLUSION CRITERIA: * Patients must not have received prior radiation therapy to the breast at any time for any reason * Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible * Patients treated with a mastectomy are NOT eligible * Any patient with active local-regional disease prior to registration is not eligible * No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years * Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy * Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00836186

{ "NCT_ID" : "NCT04117750", "Brief_Title" : "Impact of Vitamin D Supplementation on Cardiometabolic Status and Androgen Profile in Polycystic Ovary Syndrome", "Official_title" : "Impact of Vitamin D Supplementation on the Cardiometabolic Status and Androgen Profile in Women With Polycystic Ovary Syndrome: Placebo-Controlled Clinical Trial", "Conditions" : ["Evaluations, Diagnostic Self", "Treatment Adherence"], "Interventions" : ["Dietary Supplement: cholecalciferol (vit D3)"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Polycystic ovary syndrome (PCOS) is a heterogeneous disorder of reproductive, endocrine and metabolic functions. Vitamin D has an influence on metabolic and reproductive functions. This study was designed to explore the levels of free 25 hydroxy cholecalciferol \[25(OH) D\] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation on cardiometabolic status, androgen profile and clinical features of PCOS. Detailed Description Background Polycystic ovarian syndrome (PCOS) is a heterogeneous disorder affecting 510% of women of reproductive age. It is a disorder that affects the reproductive, endocrine and metabolic functions and is the leading cause of chronic anovulation leading to infertility. PCOS is characterized by hyperandrogenism, chronic oligo or anovulation, and polycystic ovaries. Hyperandrogenism, in particular, is a hallmark feature of PCOS because it is strongly implicated in the genesis of the disorder; and is also associated with metabolic derangements that contribute to the underlying pathophysiology. Also, it is associated with cardiovascular risk factors including obesity, insulin resistance (IR), dyslipidemia, endothelial dysfunction, and metabolic syndrome. Vitamin D (VD) is a fat-soluble vitamin that is naturally present in very few foods and available as a dietary supplement. It is a steroid hormone with pleiotropic effects. In addition to the main effects of VD on bone and calcium metabolism, it has other roles in the body, including modulation of cell growth, neuromuscular and immune function, and reduction of inflammation. VD deficiency is now recognized as pandemic disease. Its prevalence varies according to geographic location, season, ethnicity and the standard laboratory value; of what is considered normal, deficient and insufficient. VD deficiency is a risk factor for hypertension, diabetes, and various cancers . Accumulating evidence suggests that VD deficiency might be a causal factor in the pathogenesis of IR and the metabolic syndrome in PCOS. Carotid intima-media thickness (CIMT) measured by ultrasound is a noninvasive, safe, low-cost, reproducible, and well-validated marker of preclinical atherosclerosis. PCOS is the most frequent endocrine disorder among women of reproductive age and VD deficiency is a key problem in PCOS patients conversely, the basic mechanisms underlying the favorable effects of vitamin D in PCOS are still obscure. Resolving this mechanism may provide insight into the pathophysiology of this syndrome. It can also offer a new therapeutic option for PCOS women. Thus, in the present study was designed to explore the levels of free 25 hydroxyvitamin D \[25(OH) D\] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation cardiometabolic status, androgen profile and clinical features of PCOS. Methods This placebo-controlled trial comprised 95 women with PCO recruited from Outpatient Clinics of the Endocrinology Unit of Internal Medicine and Obstetrics and Gynecology Departments, Faculty of Medicine, Zagazig University, Egypt and 50 healthy women matched to PCOS women as regard age and ethnic origin. The diagnosis of PCOS was based on the 2004 revised Rotterdam criteria .. All women underwent the menstrual history and thorough clinical examination. All patients were assessed at the study start on the third day of a spontaneous or progesterone-induced menstrual cycle. Anthropometric measures were estimated, including waist/hip ratio, height and weight then we calculated body mass index (BMI). We estimated the hirsutism score according to Ferriman and Gallwey. .Ovarian volume and antral follicular count (AFC) were evaluated by transvaginal ultrasound (TVS). PCOS patients were randomized divided to the intervention group (n=55) received vitamin D supplements (42,000 IU oral vitamin D per week and 500 mg calcium carbonate per day for 12-week), and non-intervention group (n=40) received 500 mg calcium carbonate per day for 12-week. The exclusion criteria for all women included a history of hyperandrogenic states (such as nonclassic congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, 21-hydroxylase deficiency, or hyperprolactinemia), DM, hypertension, liver, kidney, or thyroid diseases. In addition, subjects on non-steroidal anti-inflammatory drugs and multivitamin, as well as patients treated with hormone replacement therapy. At the start of the study, the participants were asked to maintain their usual diet and level of physical activity throughout the study period as well as not to receive any lipid-lowering medications and medications that might affect their reproductive physiology during the 12-week intervention. At baseline and at the endpoint of the 12 weeks of study, anthropometrical measurements were estimated as well as and blood samples were collected for biochemical analyses. Written informed consent was taken from all of the participants after explaining details and benefits as well as risks to them. The ethical committee of the Faculty of Medicine, Zagazig University approved our study protocol. 2.1. Sampling of blood Blood samples were drawn from all subjects during the early follicular phase of the menstrual cycles. One ml was collected into tubes containing fluoride for fasting plasma glucose (FPG). A second remaining part underwent immediate serum separation and was stored at -20 ◦C until analysis serum. calcium, phosphate, albumin were measured. Total cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides levels were determined using routine enzymatic methods (Spinreact, Girona, Spain). Low-density lipoprotein (LDL) cholesterol levels were calculated using the Friedewald formula. 2.2. Immunochemical assays: We measured prolactin, FSH, and LH levels via chemiluminescence immunoassays (CLIA) provided by (Immunospec Corporation, CA, USA). Serum high-sensitivity C-reactive protein (hs-CRP) concentrations were measured using high sensitivity enzyme-linked immunosorbent assays (ELISA) (Biosource, Nivelles, Belgium). We determined to fast insulin, FSH, LH, total and free testosterone, sex hormone-binding globulin (SHBG) levels using ELISA kits (DRG International, USA). We calculated insulin resistance (IR) with the homeostatic model assessment (HOMA-IR) index, which is defined as fasting serum insulin (FSI) value (µU/ml) × fasting plasma glucose value (mg/dl)/405. The B cell function was calculated using HOMA- B as (20× (fasting insulin µU/mL)/ (fasting glucose (mmol/l) - 3.5). 2.3.Determination of serum vitamin D levels Serum concentrations of 25(OH)-D were tested using enzyme-linked immunosorbent assay, \[Cat No. EQ 6411-9601, Euroimmun Medizinische Labordiagnostika AG, Germany\]. Current recommendations define VD deficiency as serum 25(OH)-D levels less than 20 ng/ml and VD insufficiency less than 30 ng/ml. 2.4. Carotid ultrasonography Carotid artery atherosclerosis was determined by one examiner for all patients across all six sites, using high-resolution B-mode ultrasound (M-Turbo®, SonoSite, Washington, Bothell, USA), according to American Society of Echocardiography protocol. #Intervention - DIETARY_SUPPLEMENT : cholecalciferol (vit D3) - 42,000 IU oral vitamin D per week and 500 mg calcium carbonate - Other Names : - calcium carbonate

#Eligibility Criteria: Inclusion Criteria: * women with PCO. The diagnosis of PCOS was based on the 2004 revised Rotterdam criteria * women must be able to swallow tablets Exclusion Criteria: * a history of hyperandrogenic states (such as nonclassic congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, 21-hydroxylase deficiency, or hyperprolactinemia) * DM3-hypertension * liver diseases * kidney diseases * Insulin-dependent diabetes * thyroid diseases. * women received non-steroidal anti-inflammatory drugs , multivitamins, and hormone replacement therapy. Sex : FEMALE Ages : - Minimum Age : 20 Years - Maximum Age : 33 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04117750

{ "NCT_ID" : "NCT00420160", "Brief_Title" : "Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?", "Official_title" : "Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?", "Conditions" : ["Lung Cancer", "Heart Disease", "COPD"], "Interventions" : ["Behavioral: Smoking cessation treatment plus health education", "Behavioral: Smoking cessation treatment plus moderate intensity exercise"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition. Detailed Description This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. A number of techniques will be used to increase compliance with the treatment program, thus more effectively isolating the effects of exercise. These include: (1) a two-week run-in period prior to randomization; (2) use of behavioral contracting prior to participant randomization; and (3) performance of all exercise on-site. Smoking cessation outcomes (continuous abstinence and point prevalence abstinence) will be verified by carbon monoxide and saliva cotinine. Physical activity will be evaluated by attendance at the supervised sessions. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition. #Intervention - BEHAVIORAL : Smoking cessation treatment plus moderate intensity exercise - BEHAVIORAL : Smoking cessation treatment plus health education

#Eligibility Criteria: Inclusion Criteria: * Healthy sedentary smokers (> 4 per day for at least one year) * Ages 18 <= age <= 65 * Must be able to give informed consent * Must live in the area for the next 3 months * Willing to use the nicotine patch to attempt smoking cessation * Must receive consent to participate from primary care physician Exclusion Criteria: * Cannot read or write fluently in the English language * Pregnancy or plans to attempt pregnancy * 60 minutes or more per week of moderate or vigorous physical activity * Smokes cigars, pipes, or uses smokeless tobacco at least once per week * Currently in a quit smoking program * Currently using NRT of any kind or using any other quit smoking method or treatment * Never had an adverse reaction to the nicotine patch resulting in discontinuation of use * Poor willingness or inability to comply with protocol requirements * An employee of the Centers for Behavioral and Preventive Medicine * Previous participant in Commit to Quit or Fit to Quit smoking cessation studies * Another member of the household is or has been enrolled in this study * Currently taking a medication that might impact heart rate response, including but not limited to: Acebutolol Atenolol Carvedilol Metoprolol Nadolol Pindolol Propranolol Timolol Medical problems: * Cardiac disease of any kind such as angina, a history of myocardial infarction or valve disease including mitral valve prolapse. Anyone with an interventional procedure such as a stent * Pain, discomfort (or other anginal equivalent) in the chest, neck, jaw, arms or other areas that may be due to ischemia * Cerebrovasular disease such as stroke or history of transient ischemic attacks * Peripheral vascular disease (such as claudication) * Diabetes (both Type I and II) * Chronic infectious disease (HIV, hepatitis) (hepatitis A is okay) * Liver disease * Cystic fibrosis (CF) * Chronic obstructive pulmonary disease (COPD) (see asthma and bronchitis under questionable) * Interstitial lung disease * Emphysema * Chronic Bronchitis * Orthopnea (difficulty breathing except in the upright position) or paroxysmal nocturnal dyspnea (sudden shortness of breath at night typically triggered by lying down) * Current diagnosis of Chronic Fatigue Syndrome * Current diagnosis of Fibromyalgia * Abnormal exercise stress test * Hypertension (anyone currently being followed and/or treated for hypertension) * Cancer treatment (other than skin cancer) within the past 6 months * Musculoskeletal problems such as osteoarthritis, gout, osteoporosis or back, hip or knee pain that can interfere with physical activity (i.e., walking at a brisk pace - about 3-mph) * Any other serious medical condition that might make exercise unsafe or unwise Psychiatric Problems * Hospitalization for a psychiatric disorder in the last 6 months * Currently suicidal or psychotic, (or suicidal/psychotic in last 6 months) * Self-report of more than three alcoholic drinks per day on 5 or more days; 5 or more alcoholic drinks on 3 or more days * Taking these specific medications for psychiatric problems: Mood stabilizer (Lithium, Depakote, Neurontin), Antipsychotics (Haldol, Clozaril, Risperdal) * Must be on other current psychiatric medications for at least three months REQUIRES MD CONSENT FOR THE SPECIFIC CONDITION * Lightheadedness, dizziness, vertigo, or fainting * Last electrocardiogram (EKG) performed was abnormal * Anemia * Previous ETT for medical reason with normal results * Irregular heart beats or palpitations in the past two years * Heart murmurs in the past two years - the person will need physician's consent and an echocardiogram showing no evidence of significant heart disease Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT00420160

{ "NCT_ID" : "NCT00268671", "Brief_Title" : "Docetaxel in Squamous Cell Carcinoma of the Head and Neck (TAX + Cisplatin in SCCHN)", "Official_title" : "Phase I/II Trial of Weekly Docetaxel and Cisplatin for Locoregional Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)", "Conditions" : ["Head and Neck Neoplasms"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Study Objectives: * To determine the MTD (maximal tolerated dose) and recommended dose of a weekly docetaxel and cisplatin combination regimen for locoregional recurrent/metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) * To determine the response rate of the recommended dose * To determine the safety and tolerability of the recommended dose #Intervention - DRUG : Docetaxel

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed (of original primary tumor) locoregional recurrent and/or metastatic following prior radiotherapy and/or surgery and not amenable to further curative local therapy for SCCHN * Measurable disease as defined by at least the longest diameter measured as 20 mm by conventional CT or 10 mm by spiral CT. Physical measurements are allowed if longest diameter is 20 mm by caliper measurements. * ECOG performance status 0 <= age <= 2 * Adequate bone marrow and hepatic function as evidenced by the following: * Hematology (Bone marrow): * Neutrophils >= 1.50 x 10^9/L * Platelets >= 100 x 10^9/L * Hemoglobin >= 10 g/dL * Hepatic function: * AST and/or ALT: < 2X ULN (Upper Limit of Normal) * Bilirubin < 1X ULN * Adequate renal function with calculated or measured glomerular filtration rate of > 60 ml/min calculated by the Cockcroft- Gault method * No severe intercurrent illness or other serious illness or medical conditions including but not limited to: * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry. * Active uncontrolled infection * Active peptic ulcer * Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry * No prior chemotherapy for recurrent/advanced SCCHN with platinum or taxane regimen (primary radiosensitizing platinum allowed). * No other diagnosed malignancy other than basal cell carcinoma of the skin or cervix carcinoma in situ Exclusion Criteria: * Prior therapy with taxanes either adjuvant, neoadjuvant, concurrent or in advanced stage disease * Prior chemotherapy for locoregional recurrent/metastatic SCCHN with palliative intent * Contraindications from * the medical history (i.e. known hepatitis, HIV) and physical exam * laboratory tests (hematology, biochemistry) * 12-lead electrocardiogram * blood pressure and pulse * Pregnancy * Breast-feeding * Treatment with any investigational product in the last 4 weeks before study entry * Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs * History of hypersensitivity to the study drug(s) or to drugs with a similar chemical structure * Impaired hepatic function, as shown by bilirubin greater than upper limits of normal and/or AST greater than 2 times upper limits of normal * Impaired renal function, as shown by measured or calculated creatinine clearance of < 60 ml/min or absolute creatinine level > 1.5 upper limit of normal Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00268671

{ "NCT_ID" : "NCT01947166", "Brief_Title" : "Pancreatic Resection, Malnutrition and Readmission", "Official_title" : "Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention", "Conditions" : ["Pancreatic Cancer", "Malnutrition"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants. #Intervention - DIETARY_SUPPLEMENT : Nestle Impact Advanced Recovery nutritional supplement - Before Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days (15 servings total) on postoperative day minus 5 through postoperative day 1 in addition to normal diet. After Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days on postoperative day 2 through postoperative day 6.

#Eligibility Criteria: Inclusion Criteria: * Adult patients (>18 years)at Duke Cancer Center * Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple) * Able to read and speak English. Exclusion Criteria: * Patients receiving preoperative enteral nutrition * Inability to tolerate preoperative oral intake Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01947166

{ "NCT_ID" : "NCT04552405", "Brief_Title" : "Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study", "Official_title" : "Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study", "Conditions" : ["Familial Adenomatous Polyposis (FAP)"], "Interventions" : ["Dietary Supplement: Anti-inflammatory Diet"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study Detailed Description a prospective pilot study #Intervention - DIETARY_SUPPLEMENT : Anti-inflammatory Diet - FAP individuals followed for 3 months a low-inflammatory diet

#Eligibility Criteria: Inclusion Criteria: * FAP patients carrying mutations in APC gene, submitted to prophylactic total colectomy/IRA (with rectum preservation) and that participate to the regular endoscopic surveillance program at IRCCS-INT. Exclusion Criteria: * FAP patients taking NSAIDs and/or Omega 3 * Patients who carried MUTYH germline mutations or had no APC mutation found. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04552405

{ "NCT_ID" : "NCT01531894", "Brief_Title" : "Continuation Study of the Oral AKT Inhibitor GSK2110183", "Official_title" : "An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies", "Conditions" : ["Cancer"], "Interventions" : ["Drug: GSK2110183 (afuresertib)"], "Location_Countries" : ["Ireland", "Korea, Republic of", "Australia", "United States", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location. #Intervention - DRUG : GSK2110183 (afuresertib) - Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning. - Other Names : - ASB183

#Eligibility Criteria: Inclusion Criteria: * Has provided signed informed consent for this study. * Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK. * Currently benefitting from continued treatment and have an acceptable safety profile with GSK2110183 as determined by the investigator following previous treatment with GSK2110183 either as monotherapy or as part of a combination treatment regimen. * Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. * Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 16 weeks after the last dose of GSK2110183. * Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 weeks after the last dose of GSK2110183. * Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study. * Maintain a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale * Subjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry. * Have adequate organ system function Exclusion Criteria: * Permanent discontinuation of GSK2110183 in the parent study due to toxicity or disease progression. * Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol. * Local access to commercially available GSK2110183. * Current use of a prohibitive medication(s) * Current use of anticoagulants * Any unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study. * History of HIV infection. * Peripheral neuropathy greater than Grade 1 * History of hepatitis B or C infection (subjects with evidence of cleared hepatitis B are permitted). * Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease). * QTcF interval greater than 500 msecs at the time of transition to this study. * Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. * Evidence of current Class II, III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study. * Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study. * Lactating female or female who becomes pregnant prior to transition to this study. * Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01531894

{ "NCT_ID" : "NCT02115139", "Brief_Title" : "GEM STUDY: Radiation And Yervoy in Patients With Melanoma and Brain Metastases", "Official_title" : "A Multicenter, Single Arm, Phase 2 Clinical Study on the Combination of Radiation Therapy and Ipilimumab, for the Treatment of Patients With Melanoma and Brain Metastases", "Conditions" : ["Melanoma", "Brain Metastases"], "Interventions" : ["Drug: Ipilimumab"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Ipilimumab adds a clinical benefit to radiation therapy in patients with melanoma metastatic to the brain. Melanoma is the third most common cancer causing brain metastases, after cancers of the lung and breast, which appears to reflect the relative propensity of melanoma to metastasize to the central nervous system (CNS). Brain metastases are responsible for 20 to 54 percent of deaths in patients with melanoma, and among those with documented brain metastases, these lesions contribute to death in up to 95 percent of cases, with an estimated median overall survival ranging between 1.8 and 10.5 months, depending upon other prognostic factors. Ipilimumab is an anti-Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) monoclonal antibody that has demonstrated a clinically relevant and statistically significant improvement in overall survival, either alone (second line) or in combination with dacarbazine (DTIC) in 1st line. Ipilimumab has shown activity against brain metastases. According to the European Medicines Agency (EMA) approved label for Yervoy®, the use of glucocorticoids at baseline (commonly prescribed when brain metastases are diagnosed) should be avoided before the administration of ipilimumab. Data show that the use of even high doses of glucocorticoids for the management of immune-related adverse events do not decrease the efficacy of Yervoy®. There is no documented experience on the efficacy of Yervoy® when given concomitantly with radiation therapy and glucocorticoids. In experimental models, radiation therapy is synergistic to anti-Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) strategies (abscopal effect). There are no published results from clinical trials on the interaction between radiation therapy and ipilimumab. #Intervention - DRUG : Ipilimumab - Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles - Other Names : - Experimental

#Eligibility Criteria: Inclusion Criteria: * Willing and able to give written informed consent. * Histologic diagnosis of melanoma. * First episode of radiological evidence of brain metastases * Be over the age of 18 years * Radiation Therapy Oncology Group-recursive partitioning analysis (RTOG-RPA) class 2 * Karnofsky performance status (PS) more than 70% * Barthel Index of Activities of Daily Living more than 10 * Measurable disease (mWHO criteria). * Adequate organ function as determine by the following criteria: * White blood count (WBC) more or equal to 2000/ microliter (uL) * Absolute neutrophil count (ANC) more than 1.5 x 109/L. * Platelet count more than 75 x 109/L. * Hemoglobin more than 9 g/dL. If the patient received a red blood count (RBC) transfusion, the required value of hemoglobin should be met at least 1 week after the most recent transfusion. * Serum creatinine less or equal to 2.0 x upper limit of normal (ULN). * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) less or equal to 2.5 x ULN for patients without liver metastasis, or less or equal to 5 times for liver metastases. * Total bilirubin less or equal 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL) * Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 26 weeks after ipilimumab is stopped Exclusion Criteria: * Patients with melanoma and brain metastases with any of the following disease-specific characteristics: * Documented evidence of prior progression of melanoma to an ipilimumab-containing regimen (i.e. received at least 2 doses of ipilimumab for either advanced disease or in the adjuvant setting and the disease progressed/relapsed (according to mWHO criteria) within 24 weeks since the first dose of ipilimumab) * Prior radiation therapy to the brain * Other prior antineoplastic therapies for brain metastases. * Patients with cerebral metastases as the only location of the disease, for which local therapy (neurosurgery, radiosurgery) could achieve a disease-free status * Patients with a rapid clinical deterioration, or with risk of herniation, or who require unstable ascending dosing of supportive medication in the last week -including anti-convulsivants, steroids and analgesics-, or who require dexamethasone more than 16 mg/d (or other glucocorticoid at an equipotent dose), or with a high lactate dehydrogenase (LDH) more than 2 x ULN. * Any other malignancy form which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or incidental prostate cancer. * Uncontrolled diabetes mellitus (HbA1c more than 9 %) * Autoimmune disease other than vitiligo or past thyroiditis under substitutive hormone therapy: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). * Other chronic intestinal diseases associated with diarrhea. * Active infection or other serious illness or medical condition. * Known active or chronic infection with HIV, Hepatitis B, or Hepatitis C. * Concomitant therapy with any of the following: interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used for the management of non-cancer related illnesses), either concomitantly or during the last 30 days prior to the beginning of the treatment. * Any experimental therapy administered in the past 30 days prior to the beginning of the treatment. * Any non-oncology vaccine therapy used for the prevention of infectious diseases (for up to 4 weeks prior to or after any dose of blinded study drug) (see definitions in protocol text) * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness. * Any other general, medical or psychological conditions which in the opinion of the investigator will make the administration of ipilimumab hazardous, or that would preclude appropriate informed consent or compliance with the protocol, or obscure the interpretation of eventual adverse events (AEs). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02115139

{ "NCT_ID" : "NCT01530581", "Brief_Title" : "Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation", "Official_title" : "A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies", "Conditions" : ["Transplantation for Hematologic Malignancies"], "Interventions" : ["Procedure: G-PB Transplant", "Procedure: G-BM Transplant"], "Location_Countries" : ["Saudi Arabia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for Haematologic Malignancies. #Intervention - PROCEDURE : G-PB Transplant - G-PB Transplant - PROCEDURE : G-BM Transplant - G-BM Transplant

#Eligibility Criteria: Inclusion Criteria: * Recipient must 1. Be between the ages of 16 and 65 years 2. Have one of the following hematologic malignancies: * Acute myeloid leukemia (de novo, secondary or therapy related) in untreated 1st relapse or in remission or with evidence of molecular relapse but blasts less than 5% * Chronic myeloid leukemia in chronic or accelerated phase (de novo or therapy related) * Myelodysplasia (de novo or therapy related) * Other hematologic malignancy (de novo or therapy related) including but not limited to: ALL (CR 1, CR2 or CR3), CLL, non-Hodgkin's lymphoma, Hodgkin's lymphoma 3. Must be receiving a myeloablative conditioning regimen of busulfan and cyclophosphamide or TBI and cyclophosphamide or other myeloablative regimen approved by the Clinical Study Chair. (Regimens containing ATG are not allowed.) 4. Have an HLA-identical sibling donor 5. Meet the transplant centre's criteria for myeloablative allogeneic transplantation* 6. Have an ECOG performance status of 0, 1 or 2 7. Have given signed informed consent Donor must * Be 18 years or older. (Upper age limit is at the discretion of the transplant physician at the collection centre.) * Be able to undergo general anesthesia and BM harvest or peripheral blood collection as per assessment by a transplant physician. (If an anesthetist assesses a donor after randomization and determines the donor should not undergo general anesthesia, then the donor and recipient will be withdrawn from the study.) * Be a sibling of the recipient * Be a 6/6 HLA match of the recipient. HLA typing is by serologic or DNA methodology for A and B and by DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution) * Have given signed informed consent Exclusion Criteria Recipient * The recipient is HIV antibody positive Donor * The donor is unable to undergo general anesthesia, bone marrow harvest or peripheral blood collection * The donor is pregnant or breastfeeding at the time of progenitor cell collection * The donor has a history of malignant disease within the last 5 years or current malignancy other than non-melanomatous in situ skin carcinoma or cervical carcinoma in situ * The donor is HIV antibody positive * The donor has a known sensitivity to E. coli-derived products * The donor and recipient are identical twins Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT01530581

{ "NCT_ID" : "NCT01579357", "Brief_Title" : "Pharmacokinetics and Metabolic Activation of Capecitabine", "Official_title" : "Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab", "Conditions" : ["Metastatic Colorectal Cancer"], "Interventions" : ["Other: blood samples"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt). #Intervention - OTHER : blood samples - Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5). day 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min

#Eligibility Criteria: Inclusion Criteria selected: * signed written informed consent * male or female > 18 years * K-ras wild type adenocarcinoma of the colon or rectum * metastatic colorectal carcinoma * ECOG <= 2 Exclusion Criteria selected: * brain metastasis * previous chemotherapy * stage 3 or 4 heart failure * uncontrolled angina * pregnancy or lactation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01579357

{ "NCT_ID" : "NCT00577876", "Brief_Title" : "Assessment of the Functional Significance of Accessory Pudendal Arteries", "Official_title" : "Assessment of the Functional Significance of Accessory Pudendal Arteries", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Procedure: Trimix Injection with Doppler Ultrasound"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary For patients with Prostate Cancer advances in medical technology have enabled us to identify 'accessory' (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). APAs running near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These arteries are preserved more than 80% of the time, depending on their size and location.With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied. Detailed Description Overall, approximately 50% of patients become impotent (inability to achieve or maintain an erect penis; also called erectile dysfunction) after radical prostatectomy (removal of the prostate). It is already known that postoperative (after surgery) erectile dysfunction does not depend solely on the preservation of the nerves going to the penis, but also to the preservation of the arteries bringing blood to the penis. Although, the presence and frequency of APAs have been studied, and the ability to preserve them has also been noted, we still do not know how much these arteries contribute to a male's erection. With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied. While there is no immediate benefit to you for participating in the study, these findings will further help our understanding of APA's and the importance in preserving them during surgery. The primary aim of this study is to determine the proportion of men with APAs for whom APAs contribute to penile blood flow. The secondary aim is to describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA. #Intervention - PROCEDURE : Trimix Injection with Doppler Ultrasound - In case a large APA was identified, it will be dissected following the usual technique. Upon completion of the dissection, patients will have intracavernosal injection of 10 units (0.1 ml) of a Trimix administered (PGE1 10 mcg/ml, papaverine hydrochloride 30 mg/mL and phentolamine mesylate 1mg/mL. Once the patient achieves a pharmacologic erection, the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion.

#Eligibility Criteria: Inclusion Criteria: * They have selected a LRP, with or without robotic assistance, by Jonathan Colelman, MD, Bertrand Guillonneau, MD, Vincent Laudone, MD, Raul Parra, MD, or Karim Touijer MD for definitive treatment of their prostate cancer after a full discussion of treatment options. Exclusion Criteria: * Patients undergoing Open Radical Prostatectomy * Patients with prior history of insulin dependent diabetes mellitus * Patient who have received prior radiation therapy to the pelvis or prostate * Patients requiring anticoagulation postoperatively * Known allergy to Phenylephrine, Alprostadil, Papaverine or Phentolamine * Patients whose systolic blood pressure is below 90 mmHg at the time of evaluation despite routine measures taken by the anesthesiologist at his best criteria. * Patients with labile hypertension or history of prior priapism * Patients with penile scarring or penile prosthesis * Patients with an International Index of Erectile Function score < 24 Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00577876

{ "NCT_ID" : "NCT02065154", "Brief_Title" : "Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis", "Official_title" : "Phase II Clinical Trial of the Use of Post-Transplant Cyclophosphamide for Graft Versus Host Disease (GvHD) Prophylaxis Following Matched Unrelated Donor (MUD) and Mismatched Unrelated Donor (MMUD)Hematopoietic Stem Cell Transplant (HSCT)", "Conditions" : ["Leukemia", "Lymphoma", "Myelodysplastic Syndrome", "Myelofibrosis", "Severe Aplastic Anemia", "Allogeneic Transplant"], "Interventions" : ["Drug: Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation. Disease recurrence and time to recurrence in patients receiving post-transplant cyclophosphamide compared to historical control without post-transplant cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset, severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as observation of Immune Reconstitution over time. Detailed Description he main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation. Disease recurrence and time to recurrence in patients receiving post-transplant cyclophosphamide compared to historical control without post-transplant cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset, severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as observation of Immune Reconstitution over time. #Intervention - DRUG : Cyclophosphamide - Other Names : - Cytoxan

#Eligibility Criteria: Inclusion Criteria: * Disease Criteria: patients must meet diagnostic criteria of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), myelodysplastic syndrome (MDS), myelofibrosis, or severe aplastic anemia. Patients will be allowed on study if they are deemed eligible for allo HCT regardless of remission status. * Age Criteria: 19 <= age <= 65 in age. * Organ Function Criteria: All organ function testing should be done within 28 days of study registration. * Cardiac: Left ventricular ejection fraction (LVEF) >= 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram. * Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) >= 50% predicted, DLCO (diffusing capacity of the lung for carbon monoxide) (corrected for hemoglobin) >= 50% of predicted. * Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl=(140-age) x weight(kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) * Hepatic: * Serum bilirubin 1.5 upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN * Alkaline phosphatase 2.5 ULN * Performance status: Karnofsky >= 70%., * Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study. * Patient has a suitable and willing HLA-8/8 matched or 6/8 mismatched (at one allele) unrelated donor identified. Exclusion Criteria: * Non-compliant to medications. * No appropriate caregivers identified. * HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive * Uncontrolled medical or psychiatric disorders. * Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration. * Active central nervous system (CNS) leukemia. * Preceding allogeneic HSCT. * Pregnancy or Breastfeeding. Sex : ALL Ages : - Minimum Age : 19 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02065154

{ "NCT_ID" : "NCT02496585", "Brief_Title" : "Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis", "Official_title" : "Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis", "Conditions" : ["Lung Cancer", "Lung Metastases"], "Interventions" : ["Drug: Nintedanib", "Drug: Prednisone", "Other: Placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib in combination with steroids, has on the lungs. Furthermore, such treatments' side effects will be studied together with quality of life. In addition, the investigators would like to determine whether they can find markers in the blood which predict worsening lung injury. #Intervention - DRUG : Nintedanib - Other Names : - BIBF 1120 - DRUG : Prednisone - OTHER : Placebo

#Eligibility Criteria: Inclusion Criteria: * Histologically/cytologically proven primary thoracic or breast malignancy, lymphoma or lung metastases (which are not required to be biopsy-proven) treated with definitive intent at MSK * Prior treatment with thoracic radiotherapy completed >4 weeks and <= 9 months prior to enrollment * Radiographic evidence of radiation pneumonitis on a CT scan of the chest with or without contrast * Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to CTCAE version 4.0 criteria * Age>=18 years * KPS > 70% * Reduction of any acute toxicity from radiation treatment to grade 1 * Written informed consent signed prior to entry into the study Exclusion Criteria: * Current oral steroid use > 4 weeks prior to registration * Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy, except the following therapies which are permitted: Pembrolizumab, Nivolumab, Afatinib and all hormonal therapies. * Mean esophageal radiation dose >45 Gy * Diagnosis of diffuse radiation pneumonitis * Untreated or symptomatic brain metastases or leptomeningeal disease * Liver metastases * Other active malignancies requiring oncologic treatment (Note: non-melanoma skin cancer, superficial bladder cancer etc. are eligible) * Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels * Active chronic Hepatitis C and/or B infection * Gastrointestinal disorders that would interfere with drug absorption * AST > 1.5 x ULN, ALT>1.5 x ULN and Bilirubin > 1.5 x ULN * >= Grade 2 proteinuria, creatinine >1.5x ULN or GFR <45 ml/min * Other investigational therapy received within 8 weeks prior to screening visit * Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrollment1 * Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential) * Conditions that may affect the patient's ability to participate in this trial, e.g. known or suspected active alcohol or drug abuse * Inherited predisposition to bleeding or thrombosis, INR >2, PT and PTT >1.5x ULN * History of bleeding disorders or thrombotic events, e.g. hemorrhagic or thrombotic events within 12 months, clinically significant or tumor-related hemoptysis, active gastrointestinal bleeding or ulcers or major injuries or surgery * ANC < 1.5 K/mcL, Platelets < 100 K/mcL, Hemoglobin < 9.0 g/dl * Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin, etc.), fibrinolysis and high dose anti-platelet therapy (ex. Plavix 150mg)^2 Myocardial infarction or unstable angina within 6 or 1 month of starting nintedanib treatment, respectively * Known inherited predisposition to thrombosis * Patient with a history of a thrombotic event within 12 months of starting nintedanib treatment * Known predisposition to bleeding * Patients with severe hepatic impairment * History of a gastrointestinal perforation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02496585

{ "NCT_ID" : "NCT02137694", "Brief_Title" : "Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer", "Official_title" : "Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.", "Conditions" : ["Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test"], "Interventions" : ["Other: vaginal auto-takings and urinary test"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) . #Intervention - OTHER : vaginal auto-takings and urinary test - vaginal auto-takings and urinary test

#Eligibility Criteria: Inclusion Criteria: * All the 25 <= age <= 65 years women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest Exclusion Criteria: * Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up. Sex : FEMALE Ages : - Minimum Age : 25 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02137694

{ "NCT_ID" : "NCT01144260", "Brief_Title" : "Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)", "Official_title" : "A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)", "Conditions" : ["B-Cell Chronic Lymphocytic Leukemia"], "Interventions" : ["Drug: bafetinib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL). Detailed Description Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells. Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling. #Intervention - DRUG : bafetinib - 250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented. - Other Names : - INNO-406

#Eligibility Criteria: Inclusion Criteria: * Age >=18 years, male or female. * B-cell chronic lymphocytic leukemia meeting the WHO criteria. * Relapsed or refractory disease with at least one of the following criteria: *progression after at least one course of a purine nucleoside analog (fludarabine phosphate, cladribine, pentostatin) * progression after at least one course of an alkylating agent (cyclophosphamide or chlorambucil) * relapse within 12 months after at least one course of either a purine nucleoside or an alkylating agent. * Capable of providing informed consent and complying with trial procedures. * ECOG performance status 0 <= age <= 2. * Requires chemotherapy for disease as shown by any of the following criteria: * measurable and progressive lymphocytosis * measurable and progressive lymphadenopathy (lymph node >=2 cm in a single diameter) * either weight loss >=10% within the past 6 months or extreme fatigue due to leukemia * fevers >=100.5 degrees F for 2 weeks with no source of infection * night sweats with no evidence of infection * progressive marrow failure (worsening anemia with hemoglobin <10 gm/dL and/or thrombocytopenia with platelet count <100,000/mm3) * massive or progressive splenomegaly (spleen >6 cm below left costal margin). * Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. [Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.] * Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. * Accessibility to the site. Exclusion Criteria: * Chemotherapy, antibody therapy, surgery within 4 weeks of study enrollment. * Exposure to any investigational agent within 30 days of the Screening Visit. * Known CNS disease. * Concurrent active malignancies except basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix. * Laboratory values: Screening creatinine clearance (calculated by Cockcroft Gault formula) of less than 50 mL/minute, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1000/mm3, hematocrit level <33% for females or <35% for males. * Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines. * Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. * History or signs of active coronary artery disease with or without angina pectoris. * Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted. * Known HIV infection. * Uncontrolled active, infection. * Major surgery within 3 weeks prior to treatment. * Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. * Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01144260

{ "NCT_ID" : "NCT00038610", "Brief_Title" : "Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia", "Official_title" : "Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia", "Conditions" : ["Leukemia"], "Interventions" : ["Drug: Vincristine", "Drug: G-CSF", "Drug: Dexamethasone", "Drug: Methotrexate", "Drug: Mesna", "Drug: Imatinib Mesylate", "Drug: Doxorubicin", "Drug: Cytarabine", "Drug: Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied. Detailed Description Before treatment starts, patients will have a complete exam, including medical history and documentation of disease, blood, and marrow tests. A chest x-ray will be taken. CT scans may be taken if needed. A bone marrow sample will be taken through a large needle. An EKG and MUGA (heart function tests) will be performed. During treatment, patients will give blood samples (about 1 tablespoon each) at least twice a week. A bone marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check on response. After two courses of chemotherapy, the tests done before treatment will be repeated to check for response. All patients will receive 2 kinds of chemotherapy courses for a total of 8 courses. Chemotherapy courses will be given through a large vein by a central venous catheter (a plastic tube usually placed under the collarbone). Imatinib mesylate will be given as a pill with the chemotherapy. Course 1 will start with cyclophosphamide given by vein over 2-3 hours every 12 hours for 6 doses over 3 days (Days 1,2,3). Mesna will be given by vein continuously for 4 days with the cyclophosphamide to protect the bladder. Doxorubicin will be given by vein over 24 hours on Day 4. Vincristine will be given by short infusion on Days 4 and 11. Dexamethasone (a steroid) will be given by mouth or by vein on Days 1-4 and 11-14. The imatinib mesylate will be given by mouth with breakfast and a large glass of water daily on Days 1-14. Medicines will be given to prevent nausea and to protect the kidneys from increased amounts of uric acid, which may be released when leukemia cells die. G-CSF (growth stimulating colony factor) will be given after completion of the chemotherapy. It is given to allow for rapid recovery of the normal marrow. G-CSF will be injected under the skin until the counts recover. Treatment to the brain will be given inside the spinal fluid with methotrexate around Day 2 and cytarabine about day 7. This is done to prevent the leukemia from developing there. For patients aged 60 years or older, this Course 1 will be given in a protective isolation room to decrease the risk of infection(s). During Course 2, patients will be given methotrexate by infusion over 24 hours on the first day and cytarabine at a high dose over 2 hours every 12 hours for 4 doses (Days 2 and 3). Citrovorum factor (leucovorin), an antidote for side effects of methotrexate, will be given by vein or by mouth for 2-3 days (Day 2 and on). Solumedrol (a steroid) will be given by vein every 12 hours for 6 doses. Imatinib mesylate will be given by mouth with breakfast and a large glass of water on Days 1-14 or daily, depending on tolerance with Course 1. G-CSF will be given as in Course 1. The treatment to the brain inside the spinal fluid will be given as in Course 1 around Days 2 and 7. The chemotherapy will alternate between hyper-CVAD plus imatinib mesylate (Courses 1, 3, 5, and 7) and methotrexate/cytarabine plus imatinib mesylate (Courses 2, 4, 6, and 8) to complete a total of 8 courses. G-CSF will be given as in Course 1. Anti-nausea medicine will be given with each course of chemotherapy. The urine will be alkalized to protect the kidneys. Antibiotics will be given by mouth to prevent infection. After the 8 courses, monthly maintenance chemotherapy plus imatinib mesylate will be given. This includes daily imatinib mesylate, monthly vincristine by vein, and prednisone by mouth for 5 days every month. Maintenance chemotherapy will be given for a total of 24 months, and will be interrupted by 2 periods of intensive chemotherapy courses with hyper-CVAD and imatinib mesylate at 6 and 13 months from the start of maintenance. Imatinib mesylate will be continued daily as tolerated indefinitely. After two courses of the intensive chemotherapy, the response to the treatment will be evaluated. If the leukemia is responding, the therapy will be continued. Patients will be taken off study if the leukemia starts to get worse. During and after completion of treatment, patients will have a complete exam, including blood tests. If needed, a chest X-ray or CT scan will be done. A bone marrow sample will be taken through a large needle. Patients will then return every 2 to 3 months for a checkup, including blood and bone marrow. X-rays and heart studies (MUGA or ECG) may be repeated if needed. An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain or to prevent leukemia in patients who have difficulty with the spinal treatments. An Ommaya reservoir is an access port inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain. Treatment will be given on an inpatient basis (3 to 5 days) for the 8 intensive courses of chemotherapy, or as indicated by the clinical condition. The maintenance treatments will be given as an outpatient, except for the courses of hyper-CVAD and imatinib mesylate. This is an investigational study. The FDA has approved imatinib mesylate for use in chronic myelogenous leukemia and other clinical research studies. About 55 patients will take part in this study. All will be from MD Anderson. #Intervention - DRUG : Imatinib Mesylate - 600 mg by mouth on days 1 - 14 for course 1, and 600 mg by mouth daily days 1-14 (or daily if tolerated with course 1) for courses 2, 4, 6, 8. - Other Names : - Gleevec, Glivec, Imatinib, STI571, STI-571, CGP-57148B, NSC-716051 - DRUG : Cyclophosphamide - 300 mg/m\^2 by vein every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m\^2) for courses 1, 3, 5, 7. - Other Names : - Cytoxan®,, Neosar® - DRUG : Doxorubicin - 50 mg/m\^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7. - Other Names : - Adriamycin ®, Rubex ®, Adriamycin PFS, Adriamycin RDF - DRUG : Vincristine - 2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7. - DRUG : Dexamethasone - 40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7. - Other Names : - Decadron - DRUG : Methotrexate - 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2 for courses 1, 3, 5, 7. 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours on day 1 of courses 2, 4, 6, 8. - DRUG : Cytarabine - 100 mg intrathecally day 7 for courses 1, 3, 5, 7. 3 gm/m2 by vein over 2 hrs every 12 hrs for 4 doses on days 2 and 3 for courses 2, 4, 6, 8. - Other Names : - Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride - DRUG : Mesna - 600 mg/m\^2 by vein daily for 24 hours for courses 1, 3, 5, 7. - Other Names : - Mesnex - DRUG : G-CSF - 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses. - Other Names : - Filgrastim, Neupogen

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of previously untreated Ph-positive ALL or previously treated in CR after 1 <= age <= 2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate. * Age > or = 15 years. Those < 15 years will be treated under compassionate IND. * Zubrod performance status < or = 2 (ECOG Scale, Appendix A). * Adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor). * Adequate cardiac function as assessed clinically by physical examination. * Signed informed consent. Exclusion Criteria: * Active serious infection not controlled by oral or intravenous antibiotics. * Treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening. * Active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year. * History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. * Prior history of treatment with imatinib mesylate. * Pregnancy or lactating in women of childbearing potential. Sex : ALL Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00038610

{ "NCT_ID" : "NCT00116935", "Brief_Title" : "Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of Gastrointestinal Stromal Tumor (GIST)", "Official_title" : "Short (12 Months) Versus Long (36 Months) Duration of Adjuvant Treatment With the Tyrosine Kinase Inhibitor Imatinib Mesylate of Operable GIST With a High Risk of Recurrence", "Conditions" : ["Sarcoma"], "Interventions" : ["Drug: imatinib mesylate", "Drug: imatinib"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST) will be randomly allocated in a 1:1 ratio to receive imatinib (Gleevec) either for 12 or for 36 months following surgery. The study participants are required to have a histologically verified GIST with a high risk of GIST recurrence despite complete removal of all macroscopic GIST tissue at surgery. The high/very high risk of recurrence is defined as one of the following: 1) the largest tumor diameter is over 10 cm; 2) the mitosis count is high (over 10 mitoses per 50 high power microscope fields, HPFs); 3) the largest tumor diameter over 5 cm and the mitosis count is over 5/50 HPFs; 4) tumor spillage has taken place into the abdominal cavity at the time of surgery or following spontaneous tumor rupture. All study participants will receive imatinib 400 mg/day orally, but the duration of imatinib administration will be determined randomly (either for 12 or for 36 months). The study participants will be followed up using blood tests and computed tomography (or MRI) of the abdomen. The computed tomography examinations will be performed at 6 month intervals for a median of 5 years. A total of 280 patients will be entered into the study. The study hypothesis is that adjuvant imatinib may prevent some of the GIST recurrences, and that there may be a difference in the rate of GIST recurrence between the two groups. Detailed Description This is an open-label, randomized, prospective, phase III, multicenter study carried out in the Nordic countries and in Germany. Following macroscopically complete surgery, the study participants will be allocated to receive imatinib either for 12 or for 36 months. At randomization, the patients are stratified into 2 strata: 1) local disease (1 GIST tumor); 2) intra-abdominal implants or resectable intra-abdominal/hepatic metastases, or intra-abdominal spillage is present, or R1 surgery has been carried out (microscopic disease has been left behind). The imatinib dose is 400 mg/day administered with food. Imatinib dose adjustments are made as per protocol. Medical history, current medication, weight, height, and ECOG performance status are recorded prior to study entry. Physical examination, blood cell counts, blood biochemistry, pregnancy test, chest X-ray or CT, and CT or MRI of the abdomen and pelvis are carried out/measured prior to study entry. FDG-PET is an optional staging examination. Research serum samples are collected for banking prior to initiating imatinib and at 6-month intervals during the study. Tumor tissue is reviewed centrally to confirm the histological diagnosis of GIST, and KIT and PDGFRA gene mutation analyses will be performed from stored GIST tissue. The study participants are monitored during adjuvant treatment and following adjuvant treatment. Physical examination, weight and ECOG performance status are assessed at 4- to 26-week intervals. Adverse events are collected using structured forms at the times of the evaluation visits. Blood cell counts and blood biochemistry are measured at 2- to 6-week intervals during imatinib therapy, and at 6-month intervals following completion of adjuvant therapy. CT or MRI examinations of the abdomen and pelvis are performed at 6-month intervals during the study. #Intervention - DRUG : imatinib mesylate - imatinib 400 mg/day orally qd for 12 months - Other Names : - Gleevec - DRUG : imatinib - imatinib 400 mg/d orally qd for 36 months - Other Names : - Gleevec - DRUG : imatinib - imatinib 400 mg/d orally qd for 36 months - Other Names : - Gleevec

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Histologically documented diagnosis of GIST * Resectable GIST * GIST removed at open surgery * Immunohistochemical documentation of GIST (immunostaining for KIT/CD117) * High risk of tumor recurrence as defined as one of the following: 1) the largest tumor diameter greater than 10.0 cm (measured by a pathologist, with any mitotic count); 2) mitotic count over 10 mitoses per 50 high power fields (HPFs) (with any tumor size); the largest tumor diameter larger than 5.0 cm and the mitotic count is over 5/50 HPFs; 4) tumor spillage into the abdominal cavity at surgery (or tumor rupture). No residual tumors must be present at laparotomy, or in postoperative CT or MRI examinations. Patients who have microscopically infiltrated margins (or suspected microscopical infiltration, R1) are also allowed to enter study. * Performance status 0, 1, or 2 (ECOG) * Adequate organ function, defined as follows: total bilirubin <1.5 x ULN (upper limit of normal), serum AST (SGOT) and ALT (SGPT) <2.5 x ULN, creatinine <1.5 x ULN, ANC (neutrophil count) >1.5 x 10^9/L, platelets >100 x 10^9/L. * Negative pregnancy test (females with childbearing potential) * Written, voluntary informed consent Exclusion Criteria: * Inoperable or metastatic GIST * Less than 1 week or more than 12 weeks has elapsed from surgery * Recurrent GIST * Patient has received any investigational agents within 28 days as calculated from the first day of the study drug dosing * Patient is less than 5 years free from another primary malignancy * Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria * Female patients who are pregnant or breast-feeding * Patient has severe or uncontrolled medical disease (i.e. uncontrolled diabetes, severe chronic renal disease, or active uncontrolled infection). Concurrent use of warfarin or acetaminophen are not allowed with imatinib. * Chronic liver disease * Known diagnosis of human immunodeficiency virus (HIV) infection * Patient has received chemotherapy for GIST * Patient has received neoadjuvant imatinib therapy prior to randomization * Radiotherapy to 25% or more of the bone marrow * Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00116935

{ "NCT_ID" : "NCT03069924", "Brief_Title" : "Gain-framed Messages and NRT for Lung Cancer Screening Patients", "Official_title" : "Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs", "Conditions" : ["Lung Cancer Screening", "Smoking Cessation"], "Interventions" : ["Behavioral: Gain-framed messaging", "Combination Product: Unframed messaging materials"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs). #Intervention - BEHAVIORAL : Gain-framed messaging - Gain-framed messaging materials - COMBINATION_PRODUCT : Unframed messaging materials - Unframed smoking cessation materials

#Eligibility Criteria: Inclusion Criteria: * >= 50 years * at least a 20-pack year history of smoking * current smoker (defined as any smoking in the past 30 days) * willing to be randomized * English speaking Exclusion Criteria: * unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia, * known allergy to adhesives * being in the immediate (within 2 weeks) post myocardial infarction period * serious arrhythmias * unstable angina pectoris * hemodynamically or electrically unstable. * current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.) Sex : ALL Ages : - Minimum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT03069924

{ "NCT_ID" : "NCT00580983", "Brief_Title" : "Optimized Intensity Modulated Irradiation for Head and Neck Cancer", "Official_title" : "Optimized Intensity Modulated Irradiation for Head and Neck Cancer", "Conditions" : ["Head and Neck Cancer"], "Interventions" : ["Drug: Carboplatin", "Drug: Paclitaxel", "Drug: 5-Fluorouracil", "Radiation: IMRT", "Drug: Cisplatin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy. Detailed Description Studies show that a dose response relationship in the salivary glands exists and that it may be possible to improve significantly post-radiation xerostomia and quality of life if radiation techniques can be devised that would spare the salivary glands while adequately treating the targets. A new treatment modality (computer-optimized IMRT) facilitates increased sparing of noninvolved tissue, specifically the sparing of both parotid glands, and more conformal high-dose delivery to the bilateral neck targets in patients with head and neck cancer. This study will evaluate the benefits regarding xerostomia-specific and general QOL in patients receiving head and neck RT using this modality. Assessment of swallowing dysfunction and aspiration will be made using videofluoroscopy. In addition, this study will evaluate the pattern of local/regional tumor recurrence, to assess whether sparing both parotid glands may cause tumor recurrence in spared neck areas. #Intervention - RADIATION : IMRT - DRUG : Paclitaxel - DRUG : Carboplatin - DRUG : Cisplatin - DRUG : 5-Fluorouracil

#Eligibility Criteria: Inclusion Criteria: * All patients must have histologically confirmed invasive cancer of the head and neck. * Irradiation to both neck sides is required. * Standard radiation techniques would irradiate most of both parotid glands to a high dose (>50 Gy). Patients with oropharyngeal, oral, nasopharyngeal, hypopharyngeal and advanced laryngeal cancer are expected to fulfill this requirement. * Patients with resectable disease that is either measurable, evaluable or non-measurable disease (post-operative) will be eligible. * Karnofsky performance status >60 * Patients receiving or not receiving chemotherapy are eligible. * All patients must sign an informed consent. * Pre-treatment laboratory criteria: * WBC (White Blood Cell) > 3500/ul, granulocyte > 1500/ul. * Platelet count > 100,000/ul. * Creatinine clearance > 60 cc/min. to receive cisplatin; creatinine clearance 30 <= age <= 59 cc/min to receive carboplatin. * Bilirubin < 1.5 mg% with no evidence of obstructive liver disease. * AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) equal to or less than 2.5 x upper limit of normal. Exclusion Criteria: * Patients who received past irradiation to the head and neck are not eligible. * Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years. * Prior head and neck radiation or prior chemotherapy. * Documented evidence of distant metastases. * Active infection. * Pregnancy or lactation; patients must use effective contraception during the course of the clinical trial. * Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment. * Patients residing in prison. * Age < 18 years. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00580983

{ "NCT_ID" : "NCT06082596", "Brief_Title" : "Study of BEBT-908 in Subjects With Advanced Hematological Tumors", "Official_title" : "A Multicenter, Open, Phase I Clinical Study of BEBT-908 for Injection in the Treatment of Relapsed Refractory Malignant Lymphoma, Multiple Myeloma and Chronic Lymphoblastic Leukemia", "Conditions" : ["Relapsed or Refractory Non-Hodgkin's Lymphoma", "Relapsed or Refractory Multiple Myeloma"], "Interventions" : ["Drug: BEBT-908 for injection"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study was to evaluate the safety and tolerance of BEBT-908 for injection in the treatment of recurrent refractory malignant lymphoma, multiple myeloma and chronic lymphoblastic leukemia, and to obtain the pharmacokinetic data and preliminary efficacy of BEBT-908 for injection, and to explore the relationship between the safety and efficacy of BEBT-908 for injection and related biomarkers. Detailed Description This study is divided into two stages: dose increasing stage and expanding into the group. Dose escalation phase: The initial dose was 10mg/m2, and the subsequent dose group was increased by 100% until the first case of grade 2 non-blood toxicity or grade 3 hematological toxicity related to the test drug and no dose-limiting toxicity, then the dose was increased by 50%, and a total of 5 dose groups were designed. In this stage, all subjects received a single dose first and were observed for 6 days. After the end of the observation period, if the subjects were safely tolerant to a single dose，then will receive the same dose of treatment for a cycle, administration regimen is 3 times a week, continuous administration for 2 weeks, withdrawal for 1 week, a total of 21 days as a cycle. Dose expansion phase: according to the results of pharmacokinetics, safety and efficacy of BEBT-908 for injection obtained in the dose escalation phase, we plan to select two doses to further observe the safety, pharmacokinetic characteristics and preliminary efficacy of BEBT-908 for injection in about 20-40 subjects with non-Hodgkin's malignant lymphoma. In this stage, all dose groups were administered continuously for 2 weeks and stopped for 1 week for a total of 21 days，until the disease progresses or withdraws. Participants will need to understand the requirements and risks of the trial, sign an informed consent form, accept the dosing regimen required by the trial protocol, and follow the investigator's guidance. #Intervention - DRUG : BEBT-908 for injection - Dose escalation phase：10 or 15、22.5、33.75、45mg/m2, intravenous drip, firstly single dose, after the observation period, the drug was administered continuously for 1 cycle (21 days), 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week. Dose expansion phase：15 or 22.5mg/m2，intravenous drip, 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week，21 days as cycle. - Other Names : - CUDC-908

#Eligibility Criteria: Inclusion Criteria: * Dose escalation phase: 1. Age >= 18 and <= 70 years, both men and women. 2. Tissue biopsy, bone marrow examination and / or hematological examination confirmed relapsed refractory （Note 1） malignant lymphoma, chronic lymphoblastic leukemia and multiple myeloma. （Note 2 and Note 3） 3. With measurable lesions . (Note 4) 4. Eastern Cooperative Oncology Group (ECOG) score<=2. 5. The level of organ function must meet the following requirements: Bone marrow: * Absolute neutrophil count (ANC) >= 1000 /μL (if recent bone marrow biopsies or smears prove tumor progression, this index can be < 1000/μL). * Hemoglobin (HGB) >= 9g/dL. * Platelet count (PLT) >= 1000000/μL (if recent bone marrow biopsies or smears prove tumor progression, this index can be < 1000000/μL). Liver function: In patients with serum bilirubin <= 1.5 ×upper limit of normal value (ULN) or Gilbert syndrome, the total bilirubin is less than 3.0 × ULN and direct bilirubin is within the normal range. Serum creatinine < 1.5×ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST)or Alkaline phosphatase (ALP) <= 2.5 ×ULN. When there is liver metastasis, ALT, AST or ALP <= 5 × ULN. *Non-pregnant women and male and female subjects who did not consider fertility during and after the trial, or who had preserved sperm or eggs in vitro before the trial, or reconsidered fertility according to reproductive function 5 years after the end of the trial. *After a comprehensive understanding, the subjects were willing to sign the informed consent form. Note 1: relapse or refractory is defined as follows: Chronic Lymphoblastic Leukemia: subjects who are ineffective after at least 2 chemotherapy regimens, and the subjects are not suitable or refuse to transplant. Relapse: the patient reached Complete Response (CR) or Partial Response (PR), and Progressive Disease (PD) >= 6 months later. Refractory: failed treatment (without CR or PR) or PD less than 6 months after the last chemotherapy. Malignant Lymphoma: refractory or relapse after at least 2 chemotherapy regimens. Multiple Myeloma: relapse or refractory is defined as relapse or disease progression after at least 2 chemotherapy regimens (refractory occurred during the last chemotherapy or within 60 days after the last medication). Note 2: Malignant Lymphoma includes B-cell non-Hodgkin's lymphoma, B-cell Hodgkin's lymphoma, diffuse large B-cell lymphoma, T-cell lymphoma and so on. Note 3: If the subjects can provide test results to confirm the nature of the disease and the researchers determine that the nature of the disease has not changed, there is no need for reexamination. Note 4: For subjects with malignant lymphoma, the lesions are measured by computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) / PET-CT. Bone marrow biopsy or smear may be performed in the evaluation of curative effect. For subjects with multiple myeloma, it can be accepted that bone marrow biopsy or smear may be performed during the evaluation of the curative effect. For subjects with chronic lymphoblastic leukemia, it can be accepted that bone marrow biopsy or smear may be performed during the evaluation of the curative effect. * Dose expansion phase: 1. After a comprehensive understanding, the subjects were willing to sign the informed consent form. 2. Age >= 18 and <= 70 years, both men and women. 3. Tissue biopsy confirmed as relapse or refractory (Note 1) non-Hodgkin's lymphoma. 4. With measurable lesions .(Note 4) 5. Eastern Cooperative Oncology Group (ECOG) score<=2. 6. The level of organ function must meet the following requirements: Bone marrow: * Absolute neutrophil count (ANC) >= 1000 /μL. * Hemoglobin (HGB) >= 8g/dL. * Platelet count (PLT) >= 1000000/μL (if recent bone marrow biopsies or smears prove tumor progression, this index can be < 1000000/μL). Liver function: In patients with serum bilirubin <= 1.5 ×upper limit of normal value (ULN) or Gilbert syndrome, the total bilirubin is less than 3.0 × ULN and direct bilirubin is within the normal range. Serum creatinine < 1.5×ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) or Alkaline phosphatase (ALP) <= 2.5 ×ULN. When there is liver metastasis, ALT, AST or ALP <= 5 × ULN. *Non-pregnant women and male and female subjects who did not consider fertility during and after the trial, or who had preserved sperm or eggs in vitro before the trial, or reconsidered fertility according to reproductive function 5 years after the end of the trial. Note 1: relapse or refractory is defined as refractory or relapse after at least 2 chemotherapy regimens. Note 2: The lesions are measured by computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) / PET-CT. Bone marrow biopsy or smear may be performed in the evaluation of curative effect. Exclusion Criteria: * Dose escalation phase: 1. Severe allergies to research drugs or any of their excipients are known. 2. Because the research drugs may have genotoxicity, mutagenicity and teratogenicity, the following subjects should be excluded: men and women who plan to reproduce within 5 years without in vitro preservation of sperm or eggs before the trial, unless follow-up studies confirm reproductive safety; pregnant or lactating women. 3. The treatment of the subjects before the trial: 1. Bone marrow transplantation was performed within 3 months before enrolling the group. 2. Received bone marrow inhibitory chemotherapy or biotherapy within 3 weeks before enrolling the group. 3. Before enrolling the group, the subjects had been treated with any persistent or intermittent small molecular targeted drugs (Phosphoinositide 3-kinase (PI3K) inhibitors or Mammalian Target of Rapamycin (mTOR) inhibitors or Histone Deacetylase (HDAC) inhibitors). Subjects in the dose increasing phase of this study will not be subject to the exclusion criteria of this article if they participate in the expanded group phase screening. 4. Within 3 months before enrolling the group, subjects received radiotherapy that affected the efficacy evaluation of this study, or local supportive radiotherapy that affected the bone marrow function of the subjects. 5. Subjects received any hematopoietic colony stimulating factor therapy (such as granulocyte colony stimulating factor （G-CSF）, granulocyte macrophage colony stimulating factor（GM-CSF）) within 2 weeks before enrolling the group (Note 1). 6. Major surgery was performed within 14 days before enrolling the group, or the side effects of the operation were not stable. 7. Subjects received glucocorticoid prednisone daily >10mg (or equivalent drug) treatment within 7 days before enrollment. (Note 2) 4. After the previous treatment (chemotherapy or biotherapy), there was persistent toxicity of grade 2 or above, which was not stable at the time of admission (except hair loss). 5. The organ systems of the subjects were as follows: 1. Diabetes mellitus with poorly controlled blood sugar. 2. Severe lung disease (Common Terminology Criteria for Adverse Events Version 4.03（CTCAE V4.03）, III-IV). 3. Active heart disease (Note 3) (New York Heart Association grade III and IV). 4. Has significant renal or liver dysfunction. 5. Poorly controlled active hepatitis B or C disease (Note 4). 6. Primary central nervous system lymphoma or metastasis of central nervous system lymphoma. 7. A history of mental illness or emotional disorder is judged by a researcher or psychiatrist (Note 5). 6. Occurrence of disease transformation (such as Richter syndrome, prolymphocytic leukemia, etc.). 7. Combined use of drugs that cause prolonged QT interval or twisted ventricular tachycardia. 8. Clinical severe infection with active > CTCAE V4.03 Grade 2; human immunodeficiency virus (HIV) is known to be positive. 9. Persistent diarrhea (duration >= 14 days). 10. There are other active malignant tumors that may interfere with this study. 11. Anything that significantly affects the parameters of pharmacokinetics. 12. Currently receiving moderate and potent cytochrome P450 (CYP) 3A4 isozyme inhibitors or induction drugs (Note 6). 13. Are participating in other clinical trials. 14. Any condition that is unstable or may endanger the safety of subjects and their compliance with the study. 15. The researchers believe that it is not suitable for subjects treated with this regimen. Note 1: subjects who began to receive erythropoietin or daipotene within 2 weeks before entering the group can be enrolled in the group. Note 2: if used to treat diseases other than lymphoma, such as rheumatoid arthritis, rheumatic polymyalgia, adrenocortical dysfunction or asthma, subjects can receive a maximum daily dose of 10mg with a stable dose of prednisone. Note 3: includes any of the following: left ventricular ejection fraction (LVEF) found by cardiac radionuclide scanning (Multigated Radionuclide Angiography (MUGA) ) or echocardiography (ECHO) < 45% Fridericia corrected QT (between QTcF ) > 450ms (QTcF formula); unstable angina pectoris; symptomatic pericarditis; abnormal recording of the left ventricular wall in areas with persistent elevated myocardial enzymes or persistent LVEF function measurements in the past 6 months of myocardial infarction. Has a history of congestive heart failure (New York College of Cardiology Cardiac function Classification III-IV), has a record of cardiomyopathy. Note 4: a detailed assessment of the history and risk factors of hepatitis B / C must be performed on all subjects during screening. In screening all subjects with positive medical history, quantitative detection of hepatitis B virus deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) was needed based on risk factors and previous confirmation of hepatitis B/C virus infection. Hepatitis B/C virus replication within the normal range can be included in this study. Note 5: including medical records of depressive episodes, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, suicidal attempts or suicidal ideation, or thoughts of 'causing harm to others immediately', anxiety level 3 or above, etc. Note 6: allow a combination of inhibitors for weak CYP3A; a list of CYP3A4 inhibitors or inducers is shown in Annex 2 of the study scheme. * Dose expansion phase: 1. Severe allergies to research drugs or any of their excipients are known. 2. Because the research drugs may have genotoxicity, mutagenicity and teratogenicity, the following subjects should be excluded: men and women who plan to reproduce within 5 years without in vitro preservation of sperm or eggs before the trial, unless follow-up studies confirm reproductive safety; pregnant or lactating women. 3. The treatment of the subjects before the trial: 1. Before enrolling the group, the subjects had been treated with any persistent or intermittent small molecular targeted drugs (Phosphoinositide 3-kinase (PI3K) inhibitors or Mammalian Target of Rapamycin (mTOR) inhibitors or Histone Deacetylase (HDAC) inhibitors). Subjects in the dose increasing phase of this study will not be subject to the exclusion criteria of this article if they participate in the expanded group phase screening. 2. Subjects received any hematopoietic colony stimulating factor therapy (such as granulocyte colony stimulating factor （G-CSF）, granulocyte macrophage colony stimulating factor（GM-CSF）) within 2 weeks before enrolling the group (Note 1). 3. Major surgery was performed within 14 days before enrolling the group, or the side effects of the operation were not stable. 4. Subjects received glucocorticoid prednisone daily >10mg (or equivalent drug) treatment within 7 days before enrollment. (Note 2) 4. After the previous treatment (chemotherapy or biotherapy), there was persistent toxicity of grade 2 or above, which was not stable at the time of admission (except hair loss). 5. The organ systems of the subjects were as follows: 1. Diabetes mellitus with poorly controlled blood sugar. 2. Severe lung disease (Common Terminology Criteria for Adverse Events Version 4.03（CTCAE V4.03）, III-IV). 3. Active heart disease (Note 3) (New York Heart Association grade III and IV). 4. Has significant renal or liver dysfunction. 5. Poorly controlled active hepatitis B or C disease (Note 4). 6. Primary central nervous system lymphoma or metastasis of central nervous system lymphoma. 7. A history of mental illness or emotional disorder is judged by a researcher or psychiatrist (Note 5). 6. Occurrence of disease transformation (such as Richter syndrome, prolymphocytic leukemia, etc.). 7. Combined use of drugs that cause prolonged QT interval or twisted ventricular tachycardia. 8. Clinical severe infection with active > CTCAE V4.03 Grade 2; human immunodeficiency virus (HIV) is known to be positive. 9. Persistent diarrhea (duration >=14 days). 10. There are other active malignant tumors that may interfere with this study. 11. Anything that significantly affects the parameters of pharmacokinetics. 12. Currently receiving moderate and potent cytochrome P450 (CYP) 3A4 isozyme inhibitors or induction drugs (Note 6). 13. Are participating in other clinical trials. 14. Any condition that is unstable or may endanger the safety of subjects and their compliance with the study. 15. The researchers believe that it is not suitable for subjects treated with this regimen. Note 1: subjects who began to receive erythropoietin or daipotene within 2 weeks before entering the group can be enrolled in the group. Note 2: if used to treat diseases other than lymphoma, such as rheumatoid arthritis, rheumatic polymyalgia, adrenocortical dysfunction or asthma, subjects can receive a maximum daily dose of 10mg with a stable dose of prednisone. Note 3: includes any of the following: left ventricular ejection fraction (LVEF) found by cardiac radionuclide scanning (Multigated Radionuclide Angiography (MUGA) ) or echocardiography (ECHO) < 45% Fridericia corrected QT (between QTcF) > 450ms (QTcF formula); unstable angina pectoris; symptomatic pericarditis; abnormal recording of the left ventricular wall in areas with persistent elevated myocardial enzymes or persistent LVEF function measurements in the past 6 months of myocardial infarction. Has a history of congestive heart failure (New York College of Cardiology Cardiac function Classification III-IV), has a record of cardiomyopathy. Note 4: a detailed assessment of the history and risk factors of hepatitis B / C must be performed on all subjects during screening. In screening all subjects with positive medical history, quantitative detection of hepatitis B virus deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) was needed based on risk factors and previous confirmation of hepatitis B/C virus infection. Hepatitis B/C virus replication within the normal range can be included in this study. Note 5: including medical records of depressive episodes, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, suicidal attempts or suicidal ideation, or thoughts of 'causing harm to others immediately', anxiety level 3 or above, etc. Note 6: allow a combination of inhibitors for weak CYP3A; a list of CYP3A4 inhibitors or inducers is shown in Annex 2 of the study scheme. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT06082596

{ "NCT_ID" : "NCT03181854", "Brief_Title" : "Randomized Controlled Trial of Integrated Early Palliative Care", "Official_title" : "Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients", "Conditions" : ["Advanced Cancer", "Solid Tumor"], "Interventions" : ["Behavioral: Telephone coaching", "Behavioral: Consultation with PCT doctor"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study verifies whether integrated Early Palliative Care for advanced cancer patients diagnosed due to a solid tumor improve quality of life and enhances the ability to overcome the current crisis. Detailed Description Previous reports suggest that starting palliative care early in cancer patients appears to improve patient's quality of life, symptom management, depression, and anxiety. This study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. Eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months or less. The primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. Secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. At last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival. Participants of the study will be allocated in the intervention group and the control group equally. Within three weeks from the time of randomization, the first meeting with a palliative care team will be held. In the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. Once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. After the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study. #Intervention - BEHAVIORAL : Telephone coaching - Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months. - BEHAVIORAL : Consultation with PCT doctor - Consultation with PCT physician every 3 weeks.

#Eligibility Criteria: Inclusion Criteria: * Subject 20 years and older. * Subject who has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor * Subject whose ECOG performance status is between 0 to 2. * Subject with an estimated life expectancy of 12 months and less (assessed by the treating oncologist) * Subject who volunteers Exclusion Criteria: * Inability to speak, understand or write Korean. * Medical conditions that would limit adherence to participation of the clinical trial(as confirmed by their referring physician; e.g. dyspnea) * Suspension of all cancer treatment * Palliative care consultation at any time or in palliative care Sex : ALL Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03181854

{ "NCT_ID" : "NCT00996593", "Brief_Title" : "Study of Iodine-131 Anti-B1 Antibody for Patients With Non Hodgkin's Lymphoma Who Have Previously Received Rituximab", "Official_title" : "Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma Patients Who Have Previously Received Rituximab", "Conditions" : ["Lymphoma, Non-Hodgkin"], "Interventions" : ["Biological: Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab)"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single-arm, open-label, multicenter study of Iodine I-131 Anti B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) for treatment of non-Hodgkin's lymphoma (NHL) who were previously treated with rituximab antibody. Patients must have been treated with at least 4 doses of rituximab and have progressed during or following rituximab therapy. Patients will undergo two dosing phases of study. In the first phase, termed the 'dosimetric dose', patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70 minutes immediately followed by a 30-minute infusion of Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from three imaging timepoints, a patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose of radiotherapy. In the second phase, termed the 'therapeutic dose', patients will receive a 70-minute infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion of 35 mg Anti-B1 Antibody labeled with a patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy to patients with no hematologic risk factors. Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean body mass. Patients will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose). The endpoints of the study are to determine the response rate, complete response rate, duration of response, and time to progression or death, based on both a Masked Independent Randomized Radiographic and Oncologic Review (MIRROR) panel and the Investigators, and the Investigators' assessment of safety and survival of survival of Iodine-131 Anti-B1 Antibody therapy in NHL patients who have previously been treated with rituximab. #Intervention - BIOLOGICAL : Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) - Patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of Anti-B1 Antibody (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Patients will then receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of 35 mg Anti-B1 Antibody containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.

#Eligibility Criteria: Inclusion Criteria * Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation. * Patients must have evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1 Antibody or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20 positivity. * Patients must have been treated with at least 4 doses of rituximab at any time and failed to achieve an objective response (CR, CCR, PR) or relapse/progressed during treatment or following the completion of rituximab therapy. * Patients must have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least 3 months. * Patients must have an absolute granulocyte count >1500 cells/mm3 (US) and a platelet count >100,000 cells/mm3 (US) within 14 days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products. * Patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [ULN]) and hepatic function (defined as total bilirubin <1.5 x ULN and aspartate transaminase [AST] <5 x ULN) within 14 days of study entry. * Patients must have bi-dimensionally measurable disease. At least one lesion must be greater than or equal to 2 x 2 cm (by computed tomography [CT] scan). * Patients must be at least 18 years. * Patients must give written informed consent and sign an IRB/EC- approved informed consent form prior to study entry. Exclusion Criteria * Patients with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%. * Patients who received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (6 weeks of nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids must be discontinued at least 1 week prior to study entry. * Patients with prior hematopoietic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy. * Patients with active obstructive hydronephrosis. * Patients with evidence of active infection requiring intravenous (IV) antibiotics at the time of study entry. * Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation. * Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. * Patients with known HIV infection. * Patients with known brain or leptomeningeal metastases. * Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy. * Patients with previous allergic reactions to iodine. This does not include reacting to IV iodine-containing contrast materials. * Patients who previously received radioimmunotherapy. * Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with > 3500 cGy. * Patients who are HAMA positive. * Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00996593

{ "NCT_ID" : "NCT05038137", "Brief_Title" : "Time Restricted Eating on Cancer Risk", "Official_title" : "The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer", "Conditions" : ["Pre-diabetes", "Breast Cancer", "Time Restricted Feeding"], "Interventions" : ["Behavioral: Control", "Behavioral: Time restricted feeding"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months. #Intervention - BEHAVIORAL : Time restricted feeding - Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM. - BEHAVIORAL : Control - Participants will have a daily eating period equal to or greater than 12 hours.

#Eligibility Criteria: Inclusion Criteria: * Age >= 40 and <= 67; * Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7 <= age <= 6.4% and/or fasting glucose 100 <= age <= 125 mg/dL). A1c lab and/or fasting glucose criteria will need to be met within 12 months of signing consent form, can be obtained from prior lab result or study prescreening testing; * Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs; Exclusion Criteria: * Tobacco use (current or within last 2 years); * Active malignancy or history of cancer; * History of known liver disease (by serology: aspartate aminotransferase or alanine aminotransferase >= 3 times above upper limit of normal determined by lab review, imaging or biopsy: determined by patient history); * History of kidney disease (patient history and/or estimated glomerular filtration rate less than 45 mL/min/1.73m²); * History of diabetes mellitus: * History of cardiovascular disease (MI, CHF); * Current prescription medication use for diabetes; * Medication affecting glucose metabolism or appetite or immunosuppression; * Dietary restrictions: currently following vegetarian or vegan dietary pattern; * Currently following intermittent fasting or time restricted feeding pattern or use in the last 3 months; * Night shift worker (work schedule does not involve any period of work from 10 PM to 5 AM either on a regular or rotating basis); * History of weight loss >5% in the last 3 months; * History of weight loss surgery. * BMI>=40 kg/m² exclusion; * After informed consent and run in period: Insufficient documented food photography/annotated entries (does not log at least two entries a day for 10 of 14 days) during run in period will be excluded from randomization in to the intervention period. Sex : FEMALE Ages : - Minimum Age : 40 Years - Maximum Age : 67 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT05038137

{ "NCT_ID" : "NCT06209970", "Brief_Title" : "35kDa Hyaluronan Fragment Treatment of Colorectal and Rectal Cancer", "Official_title" : "Injection of 35kDa Hyaluronan Fragment Alleviates Pain Associated With Radiotherapy for Treatment of Colorectal and Rectal Cancer", "Conditions" : ["Cancer Pain"], "Interventions" : ["Drug: HA35"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary HA35 (Bioactive HA or B-HA or HA35) have good tissue permeability (B-HA injection, Ministry of Health, Registration number L20200708MP07707). HA35 might not lose HA's bioactivities of binding to a variety of hyaluronan's binding proteins or receptors, including the analgesic and anticancer effects of hyaluronan, therefore being named bioactive HA or B-HA (10) (B-HA injection, Ministry of Health, Registration number L20200708MP07707). Detailed Description The previous study has shown that naked mole rat who has high tissue content of hyaluronan and its fragments is insensitive to pain. The previous study has also shown that hyaluronan modulates pain-regulated TRPV1 channel opening, reducing peripheral nociceptor activity and pain. The previous study has again shown that local injection of 35kDa hyaluronan fragment HA35 is effective in treating inflammatory and neuropathic pain. This study employs freshly made HA35 injection for treatment of pain associated with radiotherapy for treatment of colorectal and rectal cancer. A numerical rating scale from 0 to 10 was used to assess the pain after 1 hour, 3 hours, 24 hours, 48 hours and 72 hours of the injection. #Intervention - DRUG : HA35 - All the freshly made HA35 or B-HA samples were diluted to a final concentration of 5 mg/ml. The filter membrane with 220nm pore size was used to filter freshly made HA35 or B-HA injection in order to test its human tissue permeability as \<220nm nino-particle.

#Eligibility Criteria: Inclusion Criteria: * All patients had different degrees of metastasis of the cancers, including bone metastasis. * All patients undergo targeted radiotherapy shortly before this study. * All the patient volunteers included in this study were allowed to use antibiotic compounds on and off during the treatment in order to prevent possible infection associated with the cancers for ethnic consideration. * The included patients were aged 48 <= age <= 60. Exclusion Criteria: * Can not independently determine the level of pain. * Severe bleeding and severe inflammation Sex : ALL Ages : - Minimum Age : 48 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT06209970

{ "NCT_ID" : "NCT02594826", "Brief_Title" : "Cervical Cancer Screening Intervention Among Korean American Women", "Official_title" : "Facilitating Cervical Cancer Screening Among Underserved Korean American Women", "Conditions" : ["Cervical Carcinoma"], "Interventions" : ["Behavioral: General health education control", "Behavioral: Culturally appropriate intervention"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SCREENING", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean American women. Due to the multiple factors that contribute to screening uptake, an educational program customized to Korean culture combined with navigation assistance may be effective in increasing the number of Korean American women who can access cervical cancer screening. Detailed Description PRIMARY OBJECTIVES: I. To evaluate the efficacy of a culturally-appropriate educational intervention compared to a general cancer health education program in increasing cervical cancer screening among Korean American women. SECONDARY OBJECTIVES: I. To examine the effects of a culturally-appropriate intervention on women's knowledge, psychosocial beliefs about cervical cancer and screening, and barriers to screening compared to a general cancer health education program. II. To examine the extent to which changes in knowledge, psychosocial beliefs, and barriers mediate the effects of the intervention on screening behavior. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (INTERVENTION CONDITION): Participants undergo a culturally appropriate, church-based intervention comprised of four components: 2-hour small group education sessions delivered at church sites by professional, bilingual community health educators (CHEs) that include culturally appropriate visual aids and print materials in Korean; navigation assistance, including language services, appointment scheduling, and transportation assistance from CHEs and church health workers (CHWs); referrals to Pap test sites; and a 6-month reminder letter for screening. ARM II (CONTROL CONDITION): Participants undergo 2-hour general health and cancer education by bilingual CHEs, which covers nutrition, regular check-ups, tobacco use, and cancer screening. Participants also receive pre-existing written material produced by the American Cancer Society (ACS), National Institutes of Health (NIH), and Centers for Disease Control (CDC)., and are advised to seek regular preventive health services. After completion of study, participants are followed up post-intervention and at 12 months. #Intervention - BEHAVIORAL : Culturally appropriate intervention - Church-based educational intervention combined with navigation assistance - BEHAVIORAL : General health education control - General health and cancer education

#Eligibility Criteria: Inclusion Criteria: * Self-identified Korean ethnicity * Possessing a functional telephone in the home or on person * Anticipated presence in this geographic region for a period of one year Exclusion Criteria: * A current diagnosis of cervical cancer * Have had a Pap test within the past 12 months * Are currently adherent to doctor recommended screening interval Sex : FEMALE Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT02594826

{ "NCT_ID" : "NCT03780959", "Brief_Title" : "Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)", "Official_title" : "Safety, Population Pharmacokinetics, and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) in Children With Juvenile Rheumatoid Arthritis", "Conditions" : ["Juvenile Rheumatoid Arthritis"], "Interventions" : ["Drug: Placebo", "Drug: Etanercept"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA. Detailed Description This was a two-part study. In the first part of the study, all participants received open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with disease response as defined by the JRA Definition of Improvement (DOI) using the JRA Core Set Criteria were randomized in part 2 of the study to receive placebo or continued administration of etanercept until either disease flare occurred or 4 months elapsed, whichever was earlier. Participants who did not meet the DOI at day 90, participants who had disease flare during part 2 and participants who completed the blinded part of the study were eligible to receive open-label treatment with etanercept under protocol 16.0018 (NCT00357903). #Intervention - DRUG : Etanercept - Administered twice weekly by subcutaneous injection - Other Names : - Enbrel, TNFR:Fc - DRUG : Placebo - Administered twice weekly by subcutaneous injection

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of JRA by the American College of Rheumatology (ACR) criteria. * Disease course must be polyarticular with disease duration long enough to have been given an adequate trial of non-steroidal anti-inflammatory drugs (NSAIDs) and low-dose methotrexate at a dose of at least 10 mg/m²/week * Continuing active disease, defined as >= 5 swollen joints and >= 3 joints with limitation of motion accompanied by pain, tenderness or warmth. * Disease refractory to methotrexate or intolerant of methotrexate. * Have not received disease-modifying anti-rheumatic drugs (DMARDs) within 28 days prior to enrollment. * Have not received methotrexate within 14 days prior to dosing of study drug. Exclusion Criteria: * Pregnant or nursing female * Functional class IV by ACR criteria * Unable to meet concomitant medication restrictions * Intraarticular corticosteroid injection within 4 weeks prior to enrollment * Clinically significant deviations from normal, defined as: * thrombocytopenia; platelet count < 100,000/cmm * leukopenia; total white cell count < 4000 cells/cmm * neutropenia; neutrophils < 1000 cells/cmm * hepatic transaminase levels > two times the upper limit of normal (ULN) * serum bilirubin > 2 times ULN * creatinine clearance < 90 mL/min/1.73 m² body surface area (BSA) and/or a glomerular filtration rate (GFR) < 90 mL/min/1.73 m² BSA. * known human immunodeficiency virus (HIV), hepatitis B surface antigen positivity, or hepatitis C positivity. * anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies or anti-cardiolipin antibodies present. * Previously received antibody to TNF, antibody to cluster of differentiation (CD)4, or diphtheria interleukin (IL)-2-fusion protein (DAB-IL-2) * Participated in a study of an investigational drug or biologic requiring informed consent within 3 months prior to study entry. * Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or make the patient unable to cooperate with the protocol. * History of or current psychiatric illness that would interfere with ability to comply with protocol requirements or informed consent. * History or drug or alcohol abuse that would interfere with ability to comply with protocol requirements Sex : ALL Ages : - Minimum Age : 4 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT03780959

{ "NCT_ID" : "NCT04699760", "Brief_Title" : "The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer", "Official_title" : "Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.", "Conditions" : ["Cancer Cachexia", "Side Effects", "Quality of Life"], "Interventions" : ["Dietary Supplement: Fish Oil", "Dietary Supplement: Placebo"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer. Detailed Description Primary outcomes: * Weight * Physical function * Hand-grip strength Secondary outcomes: * Quality of life * Mid-upperarm circumference * Incorporation of n-3 PUFAs into cell membranes #Intervention - DIETARY_SUPPLEMENT : Fish Oil - 8 weeks, 2.2 G EPA/day - Other Names : - Smart Fish - cancer cachexia - DIETARY_SUPPLEMENT : Placebo - Placebo

#Eligibility Criteria: Inclusion Criteria: * >=18 years * Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen Exclusion Criteria: * < 18 years * Patients in palliative care * patients with haemophilia * Patiens in treatment of anti-coagulation * Patients with genetic hyperkolesterolemia * Pre-dialytic patients (GFR<15ml/min/1,73m2 eller kreatinin >=500 mmol/L) Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04699760

{ "NCT_ID" : "NCT01880541", "Brief_Title" : "Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer", "Official_title" : "Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer", "Conditions" : ["Patients With Breast Cancer and Breast Surgery Requiring"], "Interventions" : ["Other: hypnosedation", "Other: general anesthésia"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). These cognitive disorders can range from simple reversible confusion (26%) with postoperative cognitive dysfunction without actual recovery (10%). The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive function remain to this day unknown, but appear promising. Detailed Description For twenty years, hypnosedation is offered to patients who underwent surgery as an alternative to other anesthetic techniques (general anesthesia and locoregional), in some European and Anglo-Saxon hospitals for specific surgical indications (surgery area). It is commonly used in some hospitals. The hypnosedation is little used in oncology The hypnosedation is a hypnosis technique suitable for anesthesia, namely the one associated with intravenous conscious sedation and local anesthesia hypnosis. This derived from medical hypnosis Ericksoniene technique is divided into three stages: 1. induction 2. Deepening trance 3. Déhypnotisation. This technique is currently being validated and used at national and international level, in fact it is based on 500 references and appears in the national nomenclature of the Common Classification of Medical Procedures in the code ANRP 001, states: hypnosis referred to analgesic. #Intervention - OTHER : hypnosedation - hypnosedation - OTHER : general anesthésia - general anesthesia

#Eligibility Criteria: Inclusion Criteria: * Female, over 18 and under 80 years * Diagnosis of breast cancer established (Pathology) * Life expectancy greater than 6 months * Surgery of breast lumpectomy with or without lymph node dissection, mastectomy with or without lymph node dissection, dissection isolated * ASA 1 (healthy patient) or 2 (patient with moderate to high function) according to the classification of the American Society of Anesthesiologist, * Affiliation to a social security scheme, * Information on the study, signed informed consent Exclusion Criteria: * Presence of major psychiatric disorders or psychotic behavior addiction, evaluated by neuropsychologist at the first preoperative consultation, through the test MINI (MINI> 4 positive responses for each module) * Presence of neurological disorders known untreated or evaluated by neuropsychologist at the first preoperative consultation, with the MMSE test (MMSE <24) * Patient treated morphine orally for 3 months or more * Patient is pregnant or nursing, or of childbearing potential and not using adequate contraception, * Patient included in another clinical study * Inability to undergo medical monitoring study for geographical, social or psychological * Patient deprived of liberty and most subject to a measure of legal protection or unable to consent Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01880541

{ "NCT_ID" : "NCT00160381", "Brief_Title" : "A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids", "Official_title" : "A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.", "Conditions" : ["Leiomyoma", "Menorrhagia", "Metrorrhagia"], "Interventions" : ["Drug: Placebo", "Drug: Asoprisnil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids. Detailed Description No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study. #Intervention - DRUG : Asoprisnil - 10mg Tablet, oral Daily for 12 months - DRUG : Asoprisnil - 25 mg Tablet, oral Daily for 12 months - DRUG : Placebo - Tablet, oral Daily for 12 months

#Eligibility Criteria: Inclusion Criteria: * Premenopausal women * History of regular menstrual cycles (21 <= age <= 42 days) * Diagnosis of uterine fibroid(s) * Abnormal vaginal bleeding associated with uterine fibroids * Otherwise in good health * Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails * Negative pregnancy test * Agrees to Double-barrier method of contraception * Pap smear with no evidence of malignancy or pre-malignant changes * Endometrial biopsy with no significant histological disorder Exclusion Criteria: * Any abnormal lab or procedure result the study-doctor considers important * Severe reaction(s) to or are currently using any hormone therapy * History of osteoporosis or other bone disease * Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months * History of Polycystic Ovary Syndrome or prolactinoma * MRI shows significant gynecologic disorder * Uterine size > 25 weeks gestation * Hemoglobin < 8 g/dL at Day -1 Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00160381

{ "NCT_ID" : "NCT06529445", "Brief_Title" : "Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects", "Official_title" : "Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects", "Conditions" : ["Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion"], "Interventions" : ["Drug: High Dose VC004 Capsules", "Drug: Low Dose VC004 Capsules", "Drug: Median Dose VC004 Capsules"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate Food effect and Relative bioavailability of VC004 Capsules in healthy subjects #Intervention - DRUG : High Dose VC004 Capsules - VC004 Capsules qd per period, for two periods - DRUG : Median Dose VC004 Capsules - VC004 Capsules qd per period, for two periods - DRUG : Low Dose VC004 Capsules - VC004 Capsules qd per period, for two periods

#Eligibility Criteria: Inclusion Criteria: * Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions; * Able to complete the study in compliance with the protocol; * Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 6 months after the last dose of study drug (see Appendix 5 for details); * Male and female subjects between the ages of 18 and 45 years, inclusive; * At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 19.0 <= age <= 26.0 kg/m2, inclusive; Exclusion Criteria: * More than 5 cigarettes per day on average within 3 months prior to screening; * with a history of allergies, including medication, food, mites, etc., or those known to be potentially allergic to drugs of the same class as the study drug; * History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years; * Donation or loss of a significant volume of blood (> 400 mL) within 3 months prior to screening; * History of difficulties in swallowing or any history of gastrointestinal(such as reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), liver, kidney disease (whether cured or not) or surgery that affects drug absorption or excretion within 6 months prior to screening; * Those who Have taken strong inhibitors and / or inducers of liver metabolic enzymes (CYP1A2, 2A6, 2b6, 2c8, 2c19, 3A4 and 3A5) within 28 days prior to screening :strong inhibitors of liver metabolic enzymes such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, oleandomycin etc., strong inducers of liver metabolic enzymes such as rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc; Those who Have taken inhibitors and inducers of P-gp, MRPs, BCRP, OATP and other transporters and transporters within 28 days prior to screening; See Appendix 5 for details; * Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to screening; * Taking foods that affect CYP3A4 metabolism, such as grapefruit or drinks containing grapefruit within 2 weeks prior to screening, or taking high-intensity physical exercises (such as strength training, aerobic training and football playing) within 7 days prior to screening, or any other factors that affect drug absorption, distribution, metabolism and excretion; * Participated in other clinical trials within 3 months before screening (if the subject withdraws from the study before treatment, i.e. has not been randomized or received treatment, he or she can be enrolled in the study); * Those who cannot tolerate high-fat meals or have special requirements for diet and cannot accept unified diet； * A clinically significant vital signs abnormality during screening (body temperature (axillary temperature) < 36.0 ℃ or > 37.0 ℃; Pulse < 60bpm or > 100bpm; Systolic blood pressure <90mmhg or >= 140mmHg, diastolic blood pressure <60mmhg or >= 90mmHg); * A clinically significant 12-lead ECG abnormality; * Positive test results of blood pregnancy or is lactating for female subjects; * Any clinically significant abnormalities/findings in laboratory tests, or any clinically significant disease including but not limited to gastrointestinal, renal, hepatic, neurological system, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases; * Positive test results for viral hepatitis (including hepatitis B and C), HIV antibody or syphilis antibody during screening; * Acute illness or concomitant medication from screening to the first dosing of study medication; * Consumption of chocolate or any food or beverages containing caffeine or (rich containing) xanthine within 24 h prior to screening; * Consumption of any product containing alcohol within 24 h prior to screening, or positive results from a screen for alcohol; * Positive results from a screen for urine drug test; * Cannot tolerate venipuncture and have a history of needle and blood sickness; * Subjects with Lactose intolerant; * Subjects were vaccinated within 4 weeks prior to screening, or planned to be vaccinated during the trial; * Any condition which in the opinion of Investigator is not suitable for subjects to participate in the study. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT06529445

{ "NCT_ID" : "NCT01711242", "Brief_Title" : "Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma", "Official_title" : "Phase II Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection", "Conditions" : ["Gastric Cancer"], "Interventions" : ["Drug: Oxaliplatin", "Drug: Capecitabine", "Radiation: Radiotherapy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The objective of the trial is to compare disease-free survival between adjuvant XELOX alone vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer patients with D2 dissection. Detailed Description Gastric cancer is one of the most common malignancies in China. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, the overall survival results remain unsatisfactory. The main factor accounting for high mortality rate is the relapse after surgical resection. During the past few decades, the principle of combined modality treatment has been developed and applied in gastric cancer. Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116 study had been challenged by the fact that the surgical treatment applied in the trial was gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients with extensive lymph node dissection. In ARTIST study, the addition of concurrent capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not significantly reduce recurrence after curative resection and D2 lymph node dissection in gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there was a statistically significant prolongation in disease-free survival in the concurrent treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery could achieve a significant survival benefit. The standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus, the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric cancer is essential. #Intervention - DRUG : Capecitabine - DRUG : Oxaliplatin - RADIATION : Radiotherapy

#Eligibility Criteria: Inclusion Criteria: * Histologically proven gastric cancer; >= D2 resection * Stage T1 <= age <= 4, N+ * 18 <= age <= 75 * Eastern Cooperative Oncology Group 0 <= age <= 2 * No distant metastasis * Adequate bone marrow functions (absolute neutrophil count>= 1,500/ul, blood platelet>= 100,000/ul, haemoglobin>= 10g/dl) * Adequate renal functions(serum creatinine <= 1.5mg/dl) * Adequate liver functions (serum bilirubin <= 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase <= 3 times(normal value) * Written informed consent Exclusion Criteria: * Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer; * Active infection requiring antibiotics; * Pregnant, lactating women; * Psychiatric illness, epileptic disorders; * Concurrent systemic illness not appropriate for chemotherapy; * Resection margin (+); * History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma; * D0, D1 resection; Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01711242

{ "NCT_ID" : "NCT01925131", "Brief_Title" : "S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia", "Official_title" : "S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's Leukemia)", "Conditions" : ["Acute Leukemias of Ambiguous Lineage", "B-cell Adult Acute Lymphoblastic Leukemia", "Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia", "Recurrent Adult Acute Lymphoblastic Leukemia", "Recurrent Adult Burkitt Lymphoma"], "Interventions" : ["Biological: inotuzumab ozogamicin", "Drug: vincristine sulfate", "Drug: prednisone", "Other: laboratory biomarker analysis", "Drug: cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells. Detailed Description PRIMARY OBJECTIVES: I. To assess the safety of inotuzumab ozogamicin in combination with cyclophosphamide, vincristine (vincristine sulfate) and prednisone (CVP) and to determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia \[B-ALL\], mixed phenotype, and Burkitt's). SECONDARY OBJECTIVES: I. To estimate the preliminary activity (response rate: complete remission \[CR\] + complete remission with incomplete count recovery \[CRi\]) of this combination in the expansion cohort. II. To estimate the frequency and severity of toxicities of this combination in this patient population. OUTLINE: This is a dose-escalation study of inotuzumab ozogamicin. Patients receive cyclophosphamide intravenously (IV) on day 1, vincristine sulfate IV on day 1, prednisone orally (PO) on days 1-5, and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year. #Intervention - DRUG : cyclophosphamide - Given IV - Other Names : - CPM, CTX, Cytoxan, Endoxan, Endoxana - DRUG : vincristine sulfate - Given IV - Other Names : - leurocristine sulfate, VCR, Vincasar PFS - DRUG : prednisone - Given PO - Other Names : - DeCortin, Deltra - BIOLOGICAL : inotuzumab ozogamicin - Given IV - Other Names : - CMC-544 - OTHER : laboratory biomarker analysis - Correlative studies

#Eligibility Criteria: Inclusion Criteria: * Patients must have a diagnosis of relapsed or refractory CD22-positive acute leukemia including B-ALL, mixed phenotype leukemia (biphenotypic), or Burkitt's leukemia based on World Health Organization (WHO) classification; patients with bilineal leukemia are excluded * Patients must have evidence of acute leukemia in their peripheral blood or bone marrow; patients must have >= 5% blasts in the peripheral blood or bone marrow within 14 days prior to registration; at least >= 20% of those blasts must be CD22-positive (surface) based on local immunophenotyping and histopathology * Patients must be refractory or have relapsed following prior induction therapy; a standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or dexamethasone, cytarabine/anthracycline, or high dose cytarabine * For sites with the B1931022 pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S1312 providing they meet the following criteria: * Patient is in second salvage or more; OR * Patient was treated on the standard of care arm of B1931022 and failed therapy * Patients may have received prior allogeneic transplant or autologous transplant; however, patients with prior allogeneic bone marrow transplant will be eligible only if both of the following conditions are met: * The transplant must have been performed >= 90 days prior to registration * The patient must not have >= grade 2 acute graft versus host disease (GvHD) or either moderate or severe limited chronic GvHD within 14 days prior to registration * Patients known to have Philadelphia chromosome positive (Ph+) ALL must have either failed treatment or been intolerant to treatment with at least two second or third generation tyrosine kinase inhibitors * Patients must not have received prior treatment with inotuzumab ozogamicin; previous treatment with other anti-CD22 antibodies must have been completed at least 90 days prior to registration * Patients must have Zubrod performance status 0 <= age <= 2 * Patients must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration with the following exceptions: * Monoclonal antibodies must not have been received for 1 week prior to registration * Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration. * Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any time frame prior to registration. FDA-approved TKIs may also be administered until 1 day prior to start of study therapy (C1, D1). * All drug-related toxicities must have resolved to =< grade 2 * Patients must not have a systemic bacterial, fungal, or viral infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment) * Patients must not have any other serious concurrent disease or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that would put the patient at undue risk of undergoing therapy * Patients must not have active central nervous system (CNS) involvement (by clinical evaluation); patients with previous documented history of CNS involvement of acute leukemia, or with clinical signs or symptoms consistent with CNS involvement of acute leukemia, must have a lumbar puncture which is negative for CNS involvement of acute leukemia; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture before registration; note that treatment with intrathecal therapy is recommended during protocol treatment but CNS analysis during treatment is not required * Patients must have a peripheral blast count < 25,000/uL within 2 days prior to registration; (treatment with hydroxyurea and steroids is permitted to bring the countdown) * Patients must have serum creatinine =< 2 x institutional upper limits of normal (IULN) within 7 days prior to registration * Patients must have bilirubin =< 2 x IULN within 7 days prior to registration (unless the bilirubin is primarily unconjugated) * Patients must have < grade 2 neuropathy (sensory/motor) within 7 days prior to registration * Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN within 7 days prior to registration * Patients with a history of a serious allergic or anaphylactic reaction to humanized monoclonal antibodies are not eligible * Patients must not have a history of chronic or active hepatitis B or C infection; patients must have negative hepatitis B and C serologies performed within 28 days prior to registration * Patients must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome * Patients must not have a cardiac ejection fraction < 45% or the presence of New York Heart Association stage III or IV heart failure within 14 days prior to registration; either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) may be used to determine ejection fraction * Patients must not have a myocardial infarction within 6 months prior to registration * Patients must not have a history of clinically significant arrhythmia, prolonged corrected QT (QTc) interval, or unexplained syncope not thought to be vasovagal in nature within 6 months prior to registration * Patients must not have a screening corrected QT using Fridericia's formula (QTcF) interval > 500 milliseconds (by Fridericia calculation) based on the average of triplicate electrocardiogram (EKG) performed within 7 days prior to registration; note that triplicate EKG is required at other timepoints * Patients must not have a history of chronic liver disease (or cirrhosis) * Patients who are known to be human immunodeficiency virus (HIV)+ are eligible providing they meet all of the following additional criteria within 28 days prior to registration: * CD4+ cells >= 350/mm^3 (nadir) * Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART * No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria are not eligible for this study * Patients with evidence of extramedullary disease at diagnosis will have computed tomography (CT) scan of the chest, abdomen and pelvis to obtain baseline values within 28 days prior to registration * Patients must have complete history and physical examination within 28 days prior to registration * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of 'reproductive potential' if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, 'effective contraception' also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Prior malignancy other than acute leukemia is allowed, provided it is in remission and there is no plan to treat the malignancy at the time of registration * Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S1312; specimens must be submitted to the site's preferred Clinical Laboratory Improvement Amendments (CLIA)-approved cytogenetics laboratory; reports of the results must be submitted as described; note that cytogenetics are required at other time points * Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Patients planning to enroll in this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01925131

{ "NCT_ID" : "NCT02283957", "Brief_Title" : "A Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)", "Conditions" : ["Painful Intermetatarsal Neuroma (Morton's Neuroma)"], "Interventions" : ["Drug: CNTX-4975", "Other: Placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo injected into the intermetatarsal space around a Morton's neuroma. The injection of study medication will be administered by ultrasound-guided needle placement following ankle block anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects will return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments. #Intervention - DRUG : CNTX-4975 - OTHER : Placebo

#Eligibility Criteria: Inclusion criteria: * Male or female aged >18 years at the time of the Screening Visit. * Pain associated with intermetatarsal neuroma (Morton's neuroma) for a minimum of 3 months prior to Screening. * Diagnosis of Morton's neuroma, confirmed by evidence of focal tenderness and pain in the distal third intermetatarsal space, AND either * Presence of neuroma on ultrasound, or * Elicitation of Mulder's sign or a positive Gauthier's test. * A mean neuroma foot pain score of 4 or greater during the 7 days prior to dosing (NPRS, 0 <= age <= 10) as rated daily at bedtime (9:00 PM ± 3 hours) for average pain with walking in the last 24-hours. At least 5 of 7 scores during the week prior to dosing must be recorded. * Tried conservative treatment with analgesics (acetaminophen or nonsteroidal anti-inflammatory drugs) and non-pharmacologic therapy (such as wide shoes, orthotics, and/or arch supports) without complete success. * Female not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing one of the following medically acceptable methods of birth control throughout the study period: * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before investigational product (IP) administration. * Total abstinence from sexual intercourse since the last menses before IP administration. * Intrauterine device. * Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream). * Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and daily IWRS/IVRS entries, and to communicate meaningfully with the study personnel. * Signed an Informed Consent Form approved by the Institutional Review Board. * Subject agrees to take only the rescue medications for neuroma foot pain from the time of screening through study completion, and agrees to discontinue all topical medications for neuroma pain after Screening. Exclusion criteria: * Clinically significant bursitis in either foot. * The subject has more than one painful intermetatarsal neuroma in the affected foot which, in the opinion of the Investigator, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma in the affected foot. * Radiography within 6 months of the Treatment Visit (Day 1) to exclude musculoskeletal pathology must be performed, to include any osseous abnormality such as stress fracture, osteophyte, tumor, or cyst in the bones or toes adjacent to the third inter-metatarsal space or any significant evidence of arthritis in the joints of the 3rd and 4th metatarsal-phalangeal joints or inter-phalangeal joints of the 3rd and 4th toes. * Previous neurectomy in the same nerve. * Any painful condition or prior surgery on the affected ankle or foot, which, in the judgment of the investigator, might adversely impact the interpretation of study data. * Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis etc.) or evidence of clinically meaningful ischemia which, in the judgment of the investigator and the medical monitor, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. * Other chronic pain anywhere in the body that is greater than or equal to the intensity of foot pain from intermetatarsal neuroma. * Signs of arterial insufficiency in the feet, including clinically meaningful edema. * Current use of opioids for any condition. * Corticosteroid injection in the affected foot within 30 days of Screening. * History of clearly documented allergic reaction to local anesthetics or capsaicin. * Prior use of injection with a sclerosing agent, such as alcohol or phenol, in the affected foot for Morton's neuroma. * Presence of any medical condition or unstable health status that, in the judgment of the investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease. * Regular use of anticoagulant blood thinners (except low-dose aspirin or Plavix which are allowed). * Active cutaneous disease at the anticipated site of study drug injection that would prevent the safe administration of study drug. * Ulcer or open wound anywhere on the affected foot. * Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator). * Has diabetic neuropathy or other peripheral neuropathy in the affected foot. * Use of an investigational medication in the 30 days prior to the current study or scheduled to receive such an agent while participating in the current study. * Prior participation in an ALGRX-4975 or CNTX-4975 study. * Has a history of substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, has current evidence for a substance use disorder, is receiving medicinal treatment for drug abuse, or tests positive upon urine drug screen for a substance of abuse. * Has a positive pregnancy test at the Screening or Treatment Visit. * Has any condition or is taking any medication that would be contraindicated for study participation. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02283957

{ "NCT_ID" : "NCT00487721", "Brief_Title" : "The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer", "Official_title" : "A Pilot Biomarker Study of Oral Silybin-Phytosome Followed by Prostatectomy in Patients With Localized Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: Silibin-Phytosome"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Silibinin has demonstrated anti-cancer activity in the laboratory for several different cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle. Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer patients to determine the safety of high-dose treatment. This study is for men with prostate cancer who are planning to have their prostate surgically removed. Participants will be given Silybin-Phytosome three times a day from enrollment in the study until the time of their surgery. Participation in this study will not affect the timing of surgery. We obtain blood and urine samples at the start and completion of the trial in addition to prostate tissue from the surgery. These samples will be analyzed for the effect of Silybin-Phytosome at the end of the study. Detailed Description Prostate cancer is the most common invasive malignancy and the second leading cause of cancer death in American males. In 2005, an estimated 230,000 men will be diagnosed and 30,000 will die from prostate cancer. The current estimated risk of developing prostate cancer is 1 in 6 men. Carcinogenesis and neoplastic progression of prostate cancer depend on both genetic and epigenetic factors; a multi-step process leads to progression from an androgen-dependent, non-metastatic phenotype to a more malignant, metastatic, androgen-independent phenotype. Treatment options for localized prostate cancer include watchful waiting, surgical prostatectomy, or targeted irradiation. The latter two treatments can cure cancers that are confined to the prostate gland, yet many patients have occult metastasis at the time of presentation, particularly to the bone or regional lymph nodes. Advanced prostate cancer with metastases presents a difficult therapeutic problem. Those who have disease progression with hormonal therapy have limited options. Patients initially treated with the combination of a Luteinizing Hormone Releasing Hormone (LHRH) analog and a synthetic antiandrogen occasionally respond to withdrawal of the anti-androgen. Chemotherapy is also an option in this setting, with docetaxel-based therapy having a small survival advantage in patients with hormone refractory prostate cancer. There is clearly a need for more effective regimens for patients with prostate cancer. With the current limitation in treatment options, there has been a renewed public and scientific interest in the use of less toxic herbal preparations in the treatment of cancer. Herbal supplements may play an especially important role in prostate cancer, considering its high incidence and oftentimes slow progression. However, before physicians can confidently recommend dietary supplementation, further scientific investigation is required. #Intervention - DRUG : Silibin-Phytosome - Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose. - Other Names : - Silymarin, silibinin, milk thistle

#Eligibility Criteria: Inclusion Criteria: * Patients must sign an Institutional Review Board (IRB) approved informed consent * Age greater than 18 years * Male patients with histologically documented adenocarcinoma of the prostate * Life expectancy greater than three months * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 * Adequate organ function including a total Bilirubin less than or equal to 1.5 mg/dl * Planned prostatectomy as treatment for prostate cancer. * No known metastatic disease Exclusion Criteria: * Prior definitive treatment for prostate cancer with surgery or radiation therapy * Use of an investigational medication or device within one month of initiating study therapy. * Prior systemic chemotherapy for prostate cancer or any hormonal therapy for prostate cancer. * Any use of hormonal therapy (i.e. luteinizing hormone-releasing hormone analog) or anti-androgen therapy. * Any condition or any medication which may interfere with the conduct of the study as determined by the principal investigator. Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00487721

{ "NCT_ID" : "NCT02118337", "Brief_Title" : "A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies", "Official_title" : "A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies", "Conditions" : ["Select Advanced Malignancies", "Kidney Cancer", "Clear Cell Renal Cell Carcinoma"], "Interventions" : ["Biological: Nivolumab", "Biological: Durvalumab", "Biological: MEDI0680"], "Location_Countries" : ["Netherlands", "United Kingdom", "Australia", "United States", "France", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies. Detailed Description This is a multicenter, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve participants with selected advanced malignancies. #Intervention - BIOLOGICAL : MEDI0680 - Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. - Other Names : - AMP-514 - BIOLOGICAL : Durvalumab - Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. - BIOLOGICAL : Nivolumab - Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.

#Eligibility Criteria: Inclusion Criteria: * Must be >= 18 years * Eastern Cooperative Oncology Group performance status of 0 <= age <= 1 * Adequate organ function * At least 1 prior line of therapy Exclusion Criteria: * Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study * Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment * Prior treatment with immunotherapy Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02118337

{ "NCT_ID" : "NCT02302326", "Brief_Title" : "Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome", "Official_title" : "Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome: Possible Therapeutic Implications of Insulin Sensitizers.", "Conditions" : ["Polycystic Ovary Syndrome"], "Interventions" : ["Drug: Metformin", "Dietary Supplement: Myo-inositol + folic acid"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The main objective of the present project is to evaluate the relevance of reticulum stress in the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying mechanisms of insulin resistance, which is the origin of metabolic comorbidities. Furthermore, the investigators will assess the potential of insulin sensitizers as a treatment to control endoplasmic reticulum stress markers in PCOS patients. Detailed Description To do this, the investigators will evaluate anthropometric, biochemical and hormone parameters, lipid profile and cardiovascular risk markers (using enzymatic and biochemical techniques, nephelometry, enzyme-linked immunosorbent assay, radioimmunoassay), and markers of endoplasmic reticulum stress and the insulin pathway and inflammatory and apoptotic parameters (by means of Western blot, Real Time- Polymerase Chain Reaction (RT-PCR), Luminex® xMAP® Technology ) in patients with and without PCOS. The investigators' second objective is to evaluate (using the abovementioned methodology) the efficacy of different insulin sensitizers (myoinositol and metformin) administered to PCOS patients during a 3-month period after which the investigators will analyze different parameters of oxidative stress and mitochondrial function (using Clark electrode and fluorometric techniques). #Intervention - DRUG : Metformin - Dose: metformin (1700 mg / day) for 12 weeks - DIETARY_SUPPLEMENT : Myo-inositol + folic acid - Dose: Ovusitol® (4 g myo-inositol plus 400 micrograms of folic acid/day) for 12 weeks

#Eligibility Criteria: Inclusion Criteria: * Women diagnosed with PCOS using the Rotterdam criteria * Women of reproductive age Exclusion Criteria: * Organic, malignant, haematological, infectious or inflammatory disease * History of ischaemic heart disease (stroke or thromboembolism) * Diabetes mellitus, * Secondary causes of obesity (hypothyroidism, Cushing's syndrome) * Severe hypertension. * Smoking or alcohol habit Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02302326

{ "NCT_ID" : "NCT02893930", "Brief_Title" : "Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery", "Official_title" : "A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)", "Conditions" : ["Pancreatic Neuroendocrine Tumor G1", "Pancreatic Neuroendocrine Tumor G2", "Refractory Pancreatic Neuroendocrine Carcinoma"], "Interventions" : ["Drug: Sapanisertib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth. Detailed Description PRIMARY OBJECTIVE: I. To evaluate overall response rate associated with sapanisertib (MLN0128 \[TAK-228\]) in patients with advanced pancreatic neuroendocrine tumors (PNETs). SECONDARY ENDPOINTS: I. To evaluate progression-free survival (PFS) associated with MLN0128 (TAK-228) in patients with advanced pancreatic neuroendocrine tumors (PNETs). II. To measure the safety and tolerability of MLN0128 (TAK-228) in patients with advanced PNETs. III. To evaluate disease control rate associated with MLN0128 (TAK-228) in patients with advanced PNETs. IV. To measure duration of response rate associated with MLN0128 (TAK-228) in patients with advanced PNETs. OUTLINE: Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years. #Intervention - DRUG : Sapanisertib - Given PO - Other Names : - INK-128, INK128, MLN-0128, MLN0128, TAK-228

#Eligibility Criteria: Inclusion Criteria: * Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment * Refractory disease to treatment with an mTOR inhibitor * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible * Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent * Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma * Patients must have measurable disease * Documented radiological evidence for disease progression (measurable or nonmeasurable) =< 12 months prior to enrollment * NOTE: If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation; at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) * Prior or concurrent therapy with somatostatin analogue (SSA) is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment * Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously * NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 1 * Patients must be able to swallow intact capsules * Leukocytes >= 3,000/mm^3 (within less than or equal to 14 days prior to registration) * Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within less than or equal to 14 days prior to registration) * Hemoglobin >= 10 g/dL (within less than or equal to 14 days prior to registration) * Platelets >= 100 x 10^9/L (within less than or equal to 14 days prior to registration) * Total serum bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to registration) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (within less than or equal to 14 days prior to registration) * Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min (within less than or equal to 14 days prior to registration) * NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation * Glycosylated hemoglobin (HbA1c) < 7.0% (within less than or equal to 14 days prior to registration) * Fasting serum glucose =< 130 mg/dL (within less than or equal to 14 days prior to registration) * Fasting triglycerides =< 300 mg/dL (within less than or equal to 14 days prior to registration) * Diabetics are allowed if: * Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L), OR * HbA1c =< 7% * Women must not be pregnant or breast-feeding due to potential harm to the fetus from MLN0128 (TAK-228); all females of childbearing potential must have a blood test or urine study within 7 days of registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of child-bearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 90 days (for female patients) and 120 day (for male patients) after the last dose of study drug, or agree to completely abstain from heterosexual intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug * Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met: * Brain metastases which have been treated * No evidence of disease progression for >= 3 months before the first dose of study drug * No hemorrhage after treatment * Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228 * No ongoing requirement for dexamethasone or anti-epileptic drugs * Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care Exclusion Criteria: * Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity * Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start * Patient must NOT have had previous treatment with any PI3K or AKT inhibitor * NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start * Patients must NOT have previous or concurrent malignancy within 2 years; exceptions are made for patients who meet any of the following conditions: * Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer OR * Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years * No more than 3 prior systemic treatment regimens for advanced PNET * Patients with a history of the following within =< 6 months of study entry are NOT eligible: * Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures * Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures * Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia) * New York Heart Association (NYHA) class III or IV heart failure * Pulmonary embolism * Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including: * Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed * Pulmonary hypertension * Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air * QT syndrome, or torsades de pointes * Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement * Medically significant (symptomatic) bradycardia * History of arrhythmia requiring an implantable cardiac defibrillator * Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long * Patients with known manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228) are INELIGIBLE * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are INELGIBLE because of the potential for pharmacokinetic interactions with MLN0128 (TAK-228) * NO treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, or CYP2C19 within 1 week preceding the first dose of study drug * NO patients receiving systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug * Patients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02893930

{ "NCT_ID" : "NCT03013699", "Brief_Title" : "Diet Intervention, Head and Neck Cancer, Feasibility", "Official_title" : "Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study", "Conditions" : ["Head and Neck Cancer"], "Interventions" : ["Behavioral: Cruciferous and Dark Leafy Green Intervention", "Behavioral: Usual Dietary Care"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival. #Intervention - BEHAVIORAL : Cruciferous and Dark Leafy Green Intervention - Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant. - BEHAVIORAL : Usual Dietary Care - Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.

#Eligibility Criteria: Inclusion Criteria: Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking Exclusion Criteria: Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ) Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03013699

{ "NCT_ID" : "NCT00851084", "Brief_Title" : "Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer", "Official_title" : "Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer", "Conditions" : ["Colorectal Neoplasms", "Neoplasm Metastasis"], "Interventions" : ["Drug: oxaliplatin", "Drug: 5-FU", "Drug: aflibercept", "Drug: Folinic Acid"], "Location_Countries" : ["Korea, Republic of", "Russian Federation", "Australia", "Italy", "Germany", "United Kingdom", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment. #Intervention - DRUG : aflibercept - administration: IV infusion - Other Names : - ZALTRAP™, AVE0005 - DRUG : oxaliplatin - administration: IV infusion - DRUG : 5-FU - administration: IV infusion - DRUG : Folinic Acid - administration: IV infusion

#Eligibility Criteria: Inclusion Criteria: * Histologically proven adenocarcinoma of the colon or the rectum * Metastatic disease not amenable to potentially curative treatment Exclusion Criteria: * Prior therapy for metastatic cancer of the colon or the rectum * Prior treatment with angiogenesis inhibitors The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00851084

{ "NCT_ID" : "NCT00473538", "Brief_Title" : "Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS", "Official_title" : "Effects of Structured Exercise Program Versus Hypocaloric Hyperproteic Diet on the Reproductive Function in Obese Anovulatory Infertile Patients With Polycystic Ovary Syndrome: a 24-Week Prospective Study.", "Conditions" : ["Polycystic Ovary Syndrome", "Anovulation", "Infertility"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS) improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very low. Recently, we have showed a high adherence to structured exercise training (SET) program in women with PCOS. The current study will be aimed to compare the efficacy of the SET program with a diet program on the reproductive function in obese anovulatory infertile PCOS patients. Detailed Description Forty obese anovulatory infertile PCOS patients who wish to conceive will be allocated in two study-groups according to their desire: structured exercise training (SET) group (n. 20) will undergo a SET program, whereas diet group (n. 20) will undertake a hypocaloric hyperproteic diet. The duration of the study will be of 24 weeks. At baseline, after 12 and 24 weeks clinical, endocrine and metabolic evaluations will be performed in each patient and all reproductive events obtained throughout the study will be recorded. #Intervention - BEHAVIORAL : Structured exercise training - BEHAVIORAL : Hypocaloric hyperproteic diet

#Eligibility Criteria: Inclusion Criteria: * PCOS * Anovulatory infertility * Obesity (BMI >30) Exclusion Criteria: * Age <18 or >35 years * Neoplastic, metabolic, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses * Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia * Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs know to affect sex hormone levels, carbohydrate metabolism, or appetite * Organic pelvic diseases, previous pelvic surgery, suspected peritoneal factor infertility, tubal or male factor infertility or sub-fertility Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 35 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT00473538

{ "NCT_ID" : "NCT01846390", "Brief_Title" : "Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma", "Official_title" : "A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma", "Conditions" : ["Peripheral T-Cell Lymphoma", "Diffuse Large B-Cell Lymphoma"], "Interventions" : ["Drug: Gemcitabine", "Drug: Dexamethasone", "Drug: Romidepsin", "Drug: Cisplatin"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This research is being done because it is not yet known what dose of romidepsin in combination with gemcitabine, dexamethasone, and cisplatin (GDP) can be given safely to patients with peripheral T-cell lymphoma, nor what type and severity of side effects will result from the combination of these treatments. This research is also being done because it is not clear if the addition of the new drug romidepsin to treatment with GDP can offer better results and longer survival. Detailed Description The purpose of this study is to find the highest dose of romidepsin that can safely be given in combination with gemcitabine, dexamethasone, and cisplatin (GDP) without causing very severe side effects that are not tolerable. This is done by starting at a dose lower than the one that does not cause side effects in animals. Patients are given romidepsin and GDP and watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of romidepsin (with GDP). Patients joining the study later on will get higher doses of romidepsin (with GDP) than patients who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. #Intervention - DRUG : Gemcitabine - Group 1 = 1000 mg/m2 D1, D8. Subsequent dose levels according to toxicity = 600-1000 mg/m2 D1, D15. - DRUG : Dexamethasone - 40 mg D1 - D4 - DRUG : Cisplatin - 75 mg/m2 D1 - DRUG : Romidepsin - Dose Level 0 - 6 mg/m2 D1, D8. Subsequent dose levels according to toxicity 6-14 mg/m2 D1, D15.

#Eligibility Criteria: Inclusion Criteria: * Patients with histologically confirmed PTCL. Biopsy proof of disease at initial diagnosis is mandatory. A biopsy at relapse is preferred but not mandatory. * Patients must have received one or two previous regimens of therapy for their disease (salvage chemotherapy plus autologous stem cell transplantation is considered to be one regimen). * Clinically and / or radiologically measurable disease (1 site bidimensionally measurable). Measurements / evaluations must be done within 28 days prior to registration. * Age 18 <= age <= 75. * ECOG performance status 0, 1 or 2. * Life expectancy of >= 90 days (3 months). * Laboratory Requirements: (must be done within 7 days of registration) Hematology: * Granulocytes (AGC) >= 1.0 x 10^9/L * Platelets >= 75 x 10^9/L (>= 50 if bone marrow involvement by lymphoma) Biochemistry: * AST and ALT <= 2.5x ULN (<= 5x ULN if hepatic involvement of disease) * Serum total bilirubin <= 1.5x ULN (<= 3x ULN if hepatic involvement of disease, or <=5x ULN if Gilberts Disease) * Serum Potassium >= 3.8 mmol/L* * Serum Magnesium >= 0.85 mmol/L* * NB: Patients with potassium and magnesium levels below these values are eligible if supplementation has corrected these deficits. This supplementation should continue throughout the course of the study. * Calculated creatinine clearance (Cockcroft-Gault formula) of >= 50 mL /min. * Women must be post-menopausal, surgically sterile or use reliable forms of contraception while on study and for 90 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating. * Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. * Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. * In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration. Exclusion Criteria: * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast or localized excised prostate cancer, or other solid tumours curatively treated with no evidence of disease for >= 3 years. * Central nervous system involvement, meningeal or parenchymal. Patients with CNS disease at initial presentation and who are in a CNS CR at the time of relapse are eligible. MRI scanning and / or lumbar puncture should be performed if there is clinical suspicion of active CNS disease. * HIV, active hepatitis B or current hepatitis C infection. (Hepatitis B core antibody positive, surface antigen negative patients allowed if concurrent anti-viral prophylaxis is administered. Patients with a past history of hepatitis C who have eradicated the virus are eligible.) * Any serious active disease or co-morbid medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating (according to investigator's decision). * Patients with serious cardiac illness or condition including, but not limited to: * history of documented congestive heart failure (CHF) * systolic dysfunction (LVEF < 45% by MUGA or ECHO) * high risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled) * unstable angina pectoris requiring anti-anginal medication * clinically significant valvular heart disease * evidence of transmural infarction on ECG * New York Heart Association (NYHA) Class III or IV functional status * patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation * patients with QTc > 480 msec are not eligible * Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study. * Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol are not eligible. * Patients are not eligible if they have a known hypersensitivity to the study drugs or their components. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01846390

{ "NCT_ID" : "NCT02719717", "Brief_Title" : "Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy", "Official_title" : "Prospective, Multi-Center, International Phase 2 Trial of the Use of Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy", "Conditions" : ["Lung Cancer"], "Interventions" : ["Device: Harmonic Ace+7"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This research program consists of a prospective, multi-institutional Phase 2 trial and an economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy compared to traditional techniques. It will be left up to the study credentialed surgeon investigator to decide the suitability of PA branches for sealing. This will be decided intra-operatively based on anatomy, vascular dissection and length as well as patient specific factors. Detailed Description Currently, a minority of anatomic pulmonary resections are being performed by VATS (15%). The technical difficulty and increased actual and perceived danger of VATS lobectomy is related to PA branch manipulation, stapling and division. This is the main limitation for many thoracic surgeons regarding the adoption of VATS lobectomy into their practice. Furthermore, the majority of VATS lobectomies are being performed in high volume, academic medical centers with a resultant disparity in socioeconomic status between those that undergo VATS versus open lobectomy. If we can find a way to decrease the manipulation required by the surgeon on the PA branches, these procedures will be safer, less stressful for the surgeon and therefore more prevalent for anatomical pulmonary resections. Energy utilization in VATS lobectomy may also be more cost effective than endostaplers. The use of a single device for lymph node dissection, hilar dissection, and PA branch sealing may allow for overall procedural cost savings. There may also be a potential benefit in decreasing overall length of hospital stay due to decrease in chest tube duration secondary to decreased post-operative pleural fluid output following VATS lobectomy when using energy as opposed to cautery for mediastinal lymph node dissection. Objectives: * Systematically evaluate the immediate, short- and medium-term efficacy and safety of PA sealing utilising ACE+7 in a human VATS Lobectomy/Segmentectomy. * Understand cost issues related to use of ACE+7 in human VATS Lobectomy/Segmentectomy. General satisfaction of the surgeon utilizing energy sealing devices compared to standard endostaplers will be assessed using a post-procedural online survey administered by the research team immediately following each procedure. This multi-institutional, international trial will be important to decrease the bias associated with single center studies and bolster the confidence level of thoracic surgeons in the results of the trial. Study sites have been specifically chosen in the USA, Canada and Europe in order to increase the worldwide generalizability of results. #Intervention - DEVICE : Harmonic Ace+7 - Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy

#Eligibility Criteria: Inclusion Criteria: * ability to consent * > 18 years * non-hilar tumors * pre-operative imaging (chest CT and PET-CT * invasive mediastinal staging requirement will be based on current American College of Chest Physicians (ACCP) lung cancer staging criteria and will be performed by any of the following tests, in appropriate patients, alone or in combination based on study site preference in accordance with ACCP guidelines - mediastinoscopy, mediastinotomy, VATS, endobronchial ultrasound, endoscopic ultrasound. Exclusion Criteria: * previous unilateral thoracic surgical procedure or trauma * history of mediastinal or pulmonary irradiation * anticoagulation with inability to stop anticoagulants prior to surgery * systemic vascular disease or vasculitis * uncorrectable coagulopathy * use of systemic steroids or immunosuppressive medication Pulmonary hypertension will not be an exclusion criterion as patients with pulmonary hypertension were shown to have higher bursting pressures following PA sealing in previous studies. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02719717

{ "NCT_ID" : "NCT01839032", "Brief_Title" : "Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy", "Official_title" : "A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer", "Conditions" : ["Lung Cancer"], "Interventions" : ["Drug: Vinorelbine cisplatin radiotherapy"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w). Detailed Description Vinorelbine (NVB) + CDDP is considered a standard trt in induction or concomitantly with RT (Vokes, Fournel, Krzakowski). NVBo simplifies the administration of trt and provides the same efficacy as intravenous NVB (NVBiv). In order to assess this and to improve the tolerance, a trial was started with NVBiv and NVBo + CDDP as induction followed by a fractionated administration of NVBo + CDDP during RT. #Intervention - DRUG : Vinorelbine cisplatin radiotherapy - During the induction period, patients received chemotherapy for two 3-week cycles. Bolus intravenous vinorelbine 25 mg/m², was administered on day 1, then cisplatin 80 mg/m² was administered over 1-hour infusion. Vinorelbine 60 mg/m² was also administered on day 8. Patients with objective response (OR) or no change (NC) continued the concomitant period (CP) including two additional 3-week cycles of radio chemotherapy (vinorelvine 20 mg D1 D3 D5 Cisplatin 80 mg/m² 66 Gy). - Other Names : - Navelbine

#Eligibility Criteria: Inclusion Criteria: * histologically or cytologically confirmed stage IIIA (only N2), * dry IIIB previously untreated inoperable NSCLC, * 18 <= age <= 75 old, * Karnofsky Performance Status (KPS) >= 80%, * weight loss <= 10% within the previous 3 months, * normal organ functions were eligible. * at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) [10]. Exclusion Criteria: * stages I, II, IIIA (excepted N2), IIIB with pleural effucion and stage IV, * pregnant or breastfeeding women. Women of Childbearing Age: Women of childbearing potential should take reliable contraceptive measures * Symptomatic Neuropathy > grade 1, * associated Pathology and/or not controled diseases(cardiac insuficiency, myocardial infarction within 3 months before the inclusion ; hypertension, arythmia or uncontroled hypercalcémia; infection requiering iv antibiotic administration within 2 weeks before inculion), * other associated cancer with the exception of cervical carcinoma in situ or skin cancer baso-cellular correctely treated, * Previous treatment with an other antineoplasic, * Known hypersensibility to drugs with a similar chemical structure ti this studied. * important malabsorbtion syndrom or disease of gastro-intestinal track, * Participation to another clinical trial within 30 days before inclusion Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01839032

{ "NCT_ID" : "NCT02822820", "Brief_Title" : "The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers", "Official_title" : "The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial", "Conditions" : ["Perioperative Period"], "Interventions" : ["Device: RoBi forceps-Karl Storz", "Device: Ligasure-Covidien"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs. #Intervention - DEVICE : Ligasure-Covidien - Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy - DEVICE : RoBi forceps-Karl Storz - Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy

#Eligibility Criteria: Inclusion Criteria: * Pathologic diagnosis of endometrial or cervix cancer * Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy * Clinically stage I and II endometrial cancer Exclusion Criteria: * Hematologic abnormality * Coagulation disorder * Present or past thromboembolic disease * ECOG performance >2 * Advanced stage disease * Fertility preserving surgery Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02822820

{ "NCT_ID" : "NCT01319981", "Brief_Title" : "Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia", "Official_title" : "Hyper-CVAD With Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia", "Conditions" : ["Leukemia"], "Interventions" : ["Drug: Ara-C", "Drug: G-CSF", "Drug: Dexamethasone", "Drug: Methotrexate", "Drug: Mesna", "Drug: Solu-Medrol", "Drug: Rituximab", "Drug: Doxorubicin", "Drug: Imatinib", "Drug: VSLI", "Drug: Pegfilgrastim", "Drug: Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Any time the words 'you,' 'your,' 'I,' or 'me' appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab for patients who are CD20 positive and/or imatinib, dasatinib, or ruxolitinib for patients with the Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety of this treatment will also be studied. CD20 is a protein 'marker' that is found in leukemia or lymphoma cells. This is an investigational study. Liposomal vincristine is FDA approved for the treatment of patients with CLL who have relapsed at least 2 times. All of the other study drugs used in this study are FDA approved and commercially available. The combination of liposomal vincristine with the other study drugs is also being used in research only. Up to 65 patients will take part in this study. All will be enrolled at MD Anderson. Detailed Description The Study Drugs: Adriamycin (doxorubicin) is designed to stop the growth of cancer cells, which may cause the cells to die. Cyclophosphamide is designed to disrupt with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Cytarabine (Ara-C) is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Methotrexate is designed to disrupt cells from making and repairing DNA and 'copying' themselves. Vincristine is designed to disrupt the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Liposomal Vincristine (Marqibo) is designed to help vincristine stay in the bloodstream for a longer time, more specifically target tumor tissue, and deliver more of the drug to a tumor site over a longer period of time. This may increase how effective the drug is and lower the risk of possible side effects in healthy, non-tumor tissue. Rituximab is a monoclonal antibody that is designed to attach to leukemia cells and activate a series of events that may cause the cancer cells to die. Tyrosine Kinase Inhibitors (TKI--Imatinib, Dasatinib, or Ruxolitinib) Imatinib is a drug designed to block cancer cells from growing and dividing. Dasatinib and ruxolitinib are designed to block a protein that cancer may need to grow, survive, or spread. Study Groups: If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 groups, based on your already performed diagnostic test for a certain protein, called CD20. * If you test positive for CD20, you will receive hyper-CVAD therapy plus rituximab. * If you test negative for CD20, you will receive hyper-CVAD therapy only. In addition, patients with the Philadelphia chromosome (considered Philadelphia-positive or Ph+) will receive imatinib or dasatinib in either group. Patients with Philadelphia chromosome-like disease will receive dasatinib or ruxolitinib. The study doctor will decide which drug these participants will receive. Study Drug Administration: Hyper-CVAD therapy is a combination of 7 chemotherapy drugs: the combination of adriamycin (doxorubicin), cyclophosphamide, and liposomal vincristine, alternating with the combination of cytarabine (Ara-C), dexamethasone, methotrexate, and liposomal vincristine. You will receive the 2 different study drug combinations over 21-28 day 'courses.' You will begin with Course A treatment and alternate with the Course B treatment every other course. You will stay overnight in the hospital for the first 4-5 days of each course. For Course A of treatment, you will receive cyclophosphamide, liposomal vincristine, doxorubicin, and dexamethasone. For Course B of treatment, you will receive methotrexate, cytarabine, and liposomal vincristine. Courses of treatment on this study will continue to alternate or switch between the Course A study drug combination for all odd number courses (3, 5, and 7) and the Course B study drug combination for all even number courses (4, 6, and 8) for a total of up to 8 courses. While you are on study, all doses of study drug combinations will be given through a central venous catheter (CVC). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. Course 1: On Days 1, 2, and 3 you will receive cyclophosphamide by vein over about 24 hours, mesna by vein continuously over 24 hours, and liposomal vincristine by vein over 1 hour +/- 30 minutes (Day 1 only). Mesna is given to help prevent blood in the urine, which is sometimes caused by cyclophosphamide. On Days 2 and 7, methotrexate then cytarabine will be given by intrathecal (IT) infusion directly into your spinal fluid to lower the risk of the disease spreading to the brain. On Day 4, you will receive doxorubicin by vein over 24 hours. On Day 5 or 6, G-CSF will be injected under the skin to help with the recovery of bone marrow cells recovery 24 hours after the dose of study drugs. On Day 8, you will receive liposomal vincristine by vein over 1 hour +/- 30 minutes. On Days 1-4 and Days 11-14, dexamethasone will be given by mouth with a glass of water or by vein as a short infusion. CD20 positive patients only will also receive rituximab by vein over 6 hours, on Days 1 and 8, in addition to receiving all study drugs, as described above. If you are CD20 negative, you will not receive rituximab. Ph+ participants will receive imatinib by mouth with breakfast and a large glass of water (about 8 ounces) or dasatinib by mouth on Days 1-14 during Course 1. Patients with Philadelphia chromosome-like disease will receive dasatinib 1 time each day or ruxolitinib 2 times each day on Days 1-14 during Course 1. Course 2: On Day 1, you will receive methotrexate by vein over 24 hours. On Days 2 and 3, you will receive cytarabine by vein over 2 hours every 12 hours for a total of 4 doses. You will also be given citrovorum factor (leucovorin) by vein or by mouth to help prevent the possible side effects of methotrexate. On Day 5 or 6, G-CSF will be injected under the skin to help with bone marrow recovery 24 hours after the dose of study drugs. On Days 5 and 8, cytarabine then methotrexate will be given by IT infusion to lower the risk of the disease spreading to the brain. CD20 positive patients only will also receive rituximab by vein over 4 hours, on Days 1 and 8, in addition to receiving all study drugs, as described above. If you are CD20 negative, you will not receive rituximab. Ph+ participants will receive imatinib by mouth with breakfast and a large glass of water (about 8 ounces) every day during Courses 2-8. Dasatinib will be given by mouth every day during Courses 2-8. Patients with Philadelphia chromosome-like disease will receive dasatinib 1 time each day or ruxolitinib 2 times each day. Course 1 Study Visits: * Blood (about 5 teaspoons each time) will be drawn weekly for routine tests. * During Week 2 and 3 or 4, a bone marrow aspirate will be performed to check the status of the disease. * At the end of Course 1, if the study doctor thinks it is needed, a chest X-ray or CT scan will be performed to check the status of the disease. If the study doctor thinks it is needed, any of these tests may be repeated at any time while you are receiving the study drug combination. Radiation Treatment: If you have lymphoblastic lymphoma and you have enlarged lymph glands in the chest, you may receive radiation treatment to the chest after completing 8 courses of therapy and before you begin maintenance therapy. If you are to receive radiation therapy to the chest, the study doctor will discuss this procedure and its known risks with you in more detail, and you will be given a separate consent form to sign. Maintenance Therapy -- Non-Ph+ Participants After completing 8 courses of the study drug combinations, you will begin maintenance therapy for a total of 30 months, and will be interrupted by 2 periods of intensive chemotherapy consolidation courses. Every month during maintenance therapy: * You will take 6-mercaptopurine every day by mouth. * You will receive methotrexate by vein or mouth 1 time every week. * You will receive liposomal vincristine by vein over 1 hour +/- 30 minutes on Day 1. * You will take dexamethasone by mouth on Days 1-5 each month. First intensive chemotherapy consolidation courses: * Six (6) months after you begin maintenance therapy, you will receive two months of intensive chemotherapy courses. * First, you will receive cyclophosphamide, liposomal vincristine, doxorubicin, and dexamethasone (similar to Course 1) for Month 6 of therapy. * About one (1) month later, you will receive methotrexate by vein (at a lower dose than given during Course 2) on Day 1 and pegylated asparaginase by vein over about 2 hours on Day 2. You will be given each drug 1 time each week for a total of 4 weeks for Month 7 of therapy. About eighteen (18) months after you begin maintenance therapy, you will repeat the intensive chemotherapy courses just described. Maintenance Therapy -- Ph+ Participants and Participants with Ph-like Disease: After completing 8 courses of the study drug combinations, you will begin maintenance chemotherapy plus TKI (imatinib or dasatinib if you have Ph+ disease; or dasatinib or ruxolitinib if you have Ph-like disease). Maintenance chemotherapy will be given for a total of 24 months, and will be interrupted by 2 periods of intensive chemotherapy courses and the TKI at 6 and 13 months from the start of maintenance. You will continue receiving the TKI every day from that point on, unless intolerable side effects occur. Every month during maintenance therapy: * You will take imatinib, dasatinib, or ruxolitinib every day by mouth. * You will receive liposomal vincristine by vein over 1 hour +/- 30 minutes on Day 1. * You will take dexamethasone by mouth on Days 1-5 each month. Intensive chemotherapy consolidation courses: °At six (6) and eighteen (18) months after you begin maintenance therapy, you will receive two months of intensive chemotherapy courses. You will receive cyclophosphamide, liposomal vincristine, doxorubicin, and dexamethasone with the TKI (similar to Course 1). If the disease is CD20 positive, you may receive rituximab. Blood Tests: During maintenance therapy and the intensive consolidation therapy, you will have blood (about 5 teaspoons) drawn every 4 weeks +/- 4 weeks for routine tests. After intensive chemotherapy consolidation, for as long as you continue to receive maintenance therapy, blood (about 5 teaspoons) will be drawn every 4 weeks +/- 4 weeks, until maintenance therapy is completed: Additional Tests while on Study: Every 3-6 months: * You will have a bone marrow biopsy performed to check the status of the disease. * If you have mediastinal disease, you will have a chest x-ray or CT scan. Length of Study: You will receive up to 8 courses of therapy. If you are not Ph+, you will continue to receive maintenance therapy for up to 30 months. If you are Ph+, you will continue to receive maintenance therapy for up to 24 months, followed by imatinib or dasatinib alone indefinitely. You will be taken off the study if disease gets worse, you experience intolerable side effects, or the study doctor thinks it is in your best interest. Additional Information: If you are 60 years or older, you will receive Course 1 chemotherapy in a protective isolation room to decrease the risk of any infection(s) that you may be exposed to while receiving the Course 1 treatment. #Intervention - DRUG : Rituximab - In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4. - Other Names : - Rituxan - DRUG : Imatinib - 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+). - Other Names : - Imatinib Mesylate, Gleevec, ST1571, NSC-716051 - DRUG : Cyclophosphamide - 300 mg/m2 by vein over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7 - Other Names : - Cytoxan, Neosar - DRUG : Doxorubicin - 50 mg/m2 by vein over 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7 - Other Names : - Adriamycin, Rubex - DRUG : Mesna - 600 mg/m2 by vein continuous infusion daily for 24 hours days 1-3 for courses 1, 3, 5, 7 - Other Names : - Mesnex - DRUG : VSLI - 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7 - Other Names : - Liposomal Vincristine, Vincristine Sulfate Liposomes Injection, Marqibo - DRUG : Solu-Medrol - 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8. - Other Names : - Methylprednisolone, Depo-Medrol, Medrol - DRUG : Methotrexate - 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8. - DRUG : Ara-C - 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8. - Other Names : - Cytarabine, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride - DRUG : G-CSF - 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21. - Other Names : - Filgrastim, Neupogen - DRUG : Pegfilgrastim - 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy. - Other Names : - Neulasta - DRUG : Dexamethasone - 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7 - Other Names : - Decadron

#Eligibility Criteria: Inclusion Criteria: * Newly diagnosed previously untreated ALL or lymphoblastic lymphoma >= 18 years. Allow urgent administration of cytarabine/hydrea/atra prior to starting treatment on protocol. Allow previous administration of up to one course of Hyper-CVAD and/or FDA approved TKI. * Zubrod performance status <= 3. * Adequate liver function (bilirubin <= 3.0 mg/dl unless considered due to tumor) and renal function (creatinine <= 3.0 mg/dl, unless considered due to tumor). * No active co-existing malignancy with life expectancy less than 12 months due to that malignancy. * All men and women of childbearing potential who are participating in the study must agree to use effective forms of birth control throughout the duration of their treatment. * Adequate cardiac function as assessed clinically Exclusion Criteria: * Pregnant or lactating women. Women of childbearing potential (WOCB) must have a blood or urine pregnancy test within 7 days prior to administration of the study drug. (WOCB is defined as a woman who has not undergone hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months). * Active Grade III-IV cardiac failure as defined by the New York Heart Association criteria, uncontrolled angina or MI within 6 months. * Patients with medical conditions that compromise their ability to complete the study or confound interpretation of study results. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01319981

{ "NCT_ID" : "NCT00118183", "Brief_Title" : "Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer", "Official_title" : "A Phase II Trial of Docetaxel Plus Cetuximab and Docetaxel Plus Bortezomib (NSC #681239, IND #58443) in Advanced Non-Small Cell Lung Cancer Patients With Performance Status (PS) 2", "Conditions" : ["Adenocarcinoma of the Lung", "Adenosquamous Cell Lung Cancer", "Large Cell Lung Cancer", "Malignant Pleural Effusion", "Recurrent Non-small Cell Lung Cancer", "Squamous Cell Lung Cancer", "Stage IIIB Non-small Cell Lung Cancer", "Stage IV Non-small Cell Lung Cancer"], "Interventions" : ["Biological: cetuximab", "Drug: docetaxel", "Drug: bortezomib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This randomized phase II trial is studying how well giving docetaxel together with either cetuximab or bortezomib works as first-line therapy in treating patients with stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with either cetuximab or bortezomib may be effective as first-line therapy in treating non-small cell lung cancer. Detailed Description PRIMARY OBJECTIVES: I. To evaluate the progression free survival (PFS), defined as the time between study entry and disease progression or death, for each of the two combination regimens. SECONDARY OBJECTIVES: I. To determine the overall response rate of each regimen. II. To evaluate the overall survival distributions associated with each regimen. III. To evaluate the toxicities of each regimen. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cetuximab IV over 1-2 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 4 courses receive cetuximab alone as above in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 4 courses receive bortezomib alone as above in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed monthly for 1 year, every 2 months for 2 years, and then every 4 months for 3 years. PROJECTED ACCRUAL: A total of 62 patients (31 per treatment arm) will be accrued for this study within 6-11 months. #Intervention - DRUG : docetaxel - Given IV - Other Names : - RP 56976, Taxotere, TXT - BIOLOGICAL : cetuximab - Given IV - Other Names : - C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225 - DRUG : bortezomib - Given IV - Other Names : - LDP 341, MLN341, VELCADE

#Eligibility Criteria: Inclusion Criteria: * All patients must have histologically or cytologically documented non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types) * Patients with stage IV disease are eligible * Patients with stage IIIB due to a malignant pleural effusion or supraclavicular node involvement are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and thoracic radiotherapy are not eligible) * Patients with known CNS metastases who have received therapy (surgery, XRT, gamma knife), and are neurologically stable and off steroids by the time of enrollment are eligible if they are not on enzyme-inducing anticonvulsants; patients with leptomeningeal disease are not eligible * Documentation of PS 2 must be noted on form C-1392 * Patients must have measurable or non-measurable disease * Measurable disease (target lesions): lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan * Non-measurable disease (non-target lesions): all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following: * Bone lesions * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * No prior systemic treatment for advanced NSCLC is permitted; prior treatment for early-stage disease (adjuvant) or for locally-advanced stage III disease is allowed if completed at least 12 months prior to registration * Patients must have recovered (all toxicities <= grade 1) from prior surgery and/or radiotherapy * No prior therapy which specifically and directly targets the EGFR pathway * No prior severe infusion reactions to a monoclonal antibody * No >= grade 2 peripheral neuropathy * Non-pregnant and non-nursing * No concurrent treatment with any other investigational therapy * Granulocytes >= 1,500/μl * Platelets >= 100,000/μl * Serum creatinine <= ULN * Bilirubin <= ULN * AST <= ULN Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00118183

{ "NCT_ID" : "NCT00706095", "Brief_Title" : "Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh System", "Official_title" : "An Open-label, Parallel Group Study to Explore the Pharmacokinetics of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors and Normal or Reduced Hepatic Function According to the Child-Pugh System", "Conditions" : ["Cancer"], "Interventions" : ["Drug: E7389"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin (E7389). The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) according to the Child-Pugh System for classifying hepatic impairment. #Intervention - DRUG : E7389 - E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m\^2 for normal hepatic function. - Other Names : - Eribulin mesylate - DRUG : E7389 - E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m\^2 for mild hepatic impairment (Child-Pugh A) - Other Names : - Eribulin mesylate - DRUG : E7389 - E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m\^2 for moderate hepatic impairment (Child-Pugh B) - Other Names : - Eribulin mesylate

#Eligibility Criteria: Inclusion Criteria: * Patients must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy) * Age >= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. * Life expectancy of >= 3 months * Adequate renal function as evidenced by serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 40 mL/minute (min) per the Cockcroft and Gault formula. * Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L * Patients willing and able to comply with the study protocol for the duration of the study * Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice. Additional Inclusion Criteria for the Group of Patients with No Hepatic Impairment: * All the general inclusion criteria listed above plus: Normal hepatic function as evidenced by bilirubin <= 34 μmol/l (<=2.0 mg/dL) and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) <=3 times the upper limits of normal (ULN) (in the case of liver metastases <=5 x ULN), or in the case of bone metastases, the liver specific alkaline phosphatase <=3 times the upper limits of normal (ULN), and in the case of concomitant liver metastases, <=5 x ULN. Additional Inclusion Criteria for the Group of Patients with Hepatic Impairment: * All the general inclusion criteria listed above plus: * Mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic dysfunction according to the Child-Pugh scoring system criteria, where patients with laboratory values within normal ranges will not be included in the Child-Pugh A category * Or, Moderate hepatic dysfunction (Child-Pugh B) according to the Child-Pugh scoring system criteria Exclusion Criteria: * Patients who have received any of the following treatments within the specified period before E7389 treatment start: 1. Chemotherapy, radiation, biological therapy within 3 weeks. 2. Hormonal therapy within 1 week. 3. Any investigational drug within 4 weeks. * Patients with any clinically significant laboratory abnormality except for those parameters influenced by hepatic impairment. * Patients with severe (Child-Pugh C) hepatic dysfunction according to the Child-Pugh scoring system. * Patients with encephalopathy >= Grade 1. * Patients receiving any drug known to induce or inhibit CYP3A4 activity. Clinically significant drugs are listed in a comprehensive list that can be found at http://medicine/iupui.edu/flockhart/table.htm. * Patients, who require therapeutic anti-coagulant therapy other than for line patency with warfarin or related compounds and cannot be changed to heparin-based therapy, are not eligible. * Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. * Fertile men who are not willing to use contraception or fertile men with a female partner who are not willing to use contraception * Severe/uncontrolled intercurrent illness/infection. * Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association [NYHA] Grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia). * Patients with organ allografts requiring immunosuppression (not including blood and blood components transfusions). * Patients with known positive HIV status. * Patients with brain or subdural metastases are not eligible, unless they are stable and have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment with E7389. * Patients with meningeal carcinomatosis. * Patients with a hypersensitivity to halichondrin B and/or halichondrin B-like compounds. * Patients who participated in a prior E7389 clinical trial. * Patients with preexisting neuropathy > Grade 2. * Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00706095

{ "NCT_ID" : "NCT03162731", "Brief_Title" : "Nivolumab, Ipilimumab, and Radiation Therapy in Treating Patients With Stage III-IVB Head and Neck Cancer", "Official_title" : "A Pilot Trial of Nivolumab and Ipilimumab in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Cancer; CA209-931", "Conditions" : ["Larynx", "Lip, Oral Cavity and Pharynx"], "Interventions" : ["Biological: Nivolumab", "Radiation: Simultaneous-Integrated Boost Intensity-Modulated Radiation Therapy", "Radiation: Volume Modulated Arc Therapy", "Biological: Ipilimumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot clinical trial studies the side effects of nivolumab, ipilimumab and radiation therapy in treating patients with stage IVA-B head and neck cancer. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with stage IVA-B head and neck cancer. Detailed Description PRIMARY OBJECTIVES: I. To investigate the safety of the combination of nivolumab and ipilimumab with radiation treatment for definitive management of patients with locally advanced squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. To estimate the 1 year progression-free survival (PFS) in all patients treated. II. To assess the overall response rate and overall survival of patients at one year TERTIARY OBJECTIVES: I. To explore whether PDL1 expression is associated with treatment response. II. To explore whether there is a net change in the Th1/Th2 ratio (IFN-gamma, IL-4, IL10, etc) or cell subset frequencies (M2 monocytes, myeloid-derived suppressor cells, etc) within a patient's peripheral blood either at baseline or in response to treatment is associated with treatment response. III. To explore whether exosomes or other immune related serum biomarkers change after combination therapy. #Intervention - BIOLOGICAL : Nivolumab - Given IV - Other Names : - 946414-94-4, BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo - BIOLOGICAL : Ipilimumab - Given IV - Other Names : - 477202-00-9, 720801, 732442, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4, Yervoy - RADIATION : Simultaneous-Integrated Boost Intensity-Modulated Radiation Therapy - Undergo simultaneous integrated boost integrated modulated radiation therapy - Other Names : - IMRT-SIB, Intensity Modulated Radiation Therapy Simultaneous Integrated Boost, SIB-IMRT - RADIATION : Volume Modulated Arc Therapy - Undergo volumetric modulated arc therapy - Other Names : - VMAT

#Eligibility Criteria: Inclusion Criteria: * Patients must be 18 years and older * Pathologically confirmed squamous cell carcinoma of the head and neck (SCCHN), not previously treated * Stage III-IVB disease of 1) oral cavity, 2) HPV-negative (p16-) oropharynx, 3) larynx, 4) hypopharynx * Oropharyngeal primaries that are HPV-mediated (p16+) must be stage II-III. Stage II pateints must be either N2 or, if T3N0 or T3N1 they must also have at least 20 pack year history of smoking * Tumor sample must be available for HPV p16 and PD-L1 testing * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1 * White blood cells 2000/ul or more * Absolute neutrophil count 1500/ul or more * Platelets 100,000/ul or more * Hemoglobin 9 g/dl or more * Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x the upper limit of normal * Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) * Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of the start of study drugs * Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; 'women of reproductive potential' is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level more than 40 mIU/mL * Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception * Informed consent: all subjects must be able to comprehend and sign a written informed consent document Exclusion Criteria: * Primary nasopharyngeal carcinoma * Patients with brain metastases * Patients who have participated in a study with an investigational agent or device within 2 weeks of initiation of treatment * Any prior radiotherapy to the neck * Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome) * Any prior chemotherapy or radiation therapy for the current diagnosis * Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * Any history of a sever hypersensitivity reaction to any monoclonal antibody * Any history of allergy to the study drug components * Any concurrent malignancies- exceptions include- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer that has undergone potentially curative therapy; patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 3 years post-diagnosis * Any diagnosis of immunodeficiency or current immunosuppressive therapy including >10mg/day of prednisone within 14 days of enrollment is not permitted * Patients that have an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, or resolved childhood asthma/atopy would be an exception to this rule. Inhaled or topical steroids, and adrenal replacement steroids <=10mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study * Patients with evidence of interstitial lung disease or active, non-infectious pneumonitis * Patients with a known human immunodeficiency virus infection (HIV 1/2 antibodies) or acquired immunodeficiency syndrome (HIV/AIDS), active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) * Patients who have received a live vaccine within 30 days prior to the radiation therapy * Patients must not be receiving any other investigational agents * Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial * Women must not be pregnant (as above) or breastfeeding Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03162731

{ "NCT_ID" : "NCT00161642", "Brief_Title" : "Study Evaluating CMD-193 in Advanced Malignant Solid Tumors", "Official_title" : "A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.", "Conditions" : ["Neoplasms"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected. #Intervention - DRUG : CMD-193

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available * Tumor expression of Lewis Y antigen ( > or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C) * Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to the first dose of CMD-193. * Significant prior allergic reaction to recombinant human or murine proteins Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00161642

{ "NCT_ID" : "NCT00788697", "Brief_Title" : "SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization", "Official_title" : "Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard", "Conditions" : ["Liver Neoplasms"], "Interventions" : ["Other: Unenhanced ultrasound", "Drug: SonoVue-enhanced ultrasound"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard. Detailed Description Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. #Intervention - DRUG : SonoVue-enhanced ultrasound - Contrast-enhanced ultrasound (CE-US) examination of the target lesion. Drug: SonoVue® Dose of 2.4 mL bolus injection administered intravenously. Maximum of 2 injections (4.8 mL) - Other Names : - sulfur hexafluoride microbubbles - OTHER : Unenhanced ultrasound - -Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None

#Eligibility Criteria: Inclusion Criteria: * Male/female. * Provides written Informed Consent and is willing to comply with protocol requirements. * Is at least 18 years. * Has at least 1 focal liver lesion (FLL) (target lesion) requiring work-up for characterization. Target lesions may include those: * Incidentally detected, * In subjects with chronic hepatitis or liver cirrhosis, * In subjects with known history of malignancy. * Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR * In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a contrast-enhanced (CE) CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®. Exclusion Criteria: * Has an acoustic window insufficient for adequate ultrasound examination of the liver. * Has a FLL that cannot be identified with unenhanced ultrasound. * Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion. * Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®. * Has previously been enrolled in and completed this study. * Known right to left cardiac shunt, bidirectional or transient. * Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®). * Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc. * Has received an investigational compound within 30 days before admission into this study. * Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations. * Is determined by the Investigator that the subject is clinically unsuitable for the study. * Is a pregnant or lactating female. Exclude the possibility of pregnancy by: * testing on site at the institution serum beta-human chorionic gonadotropin (βHCG) within 24 hours prior to the start of SonoVue® administration, * surgical history (e.g., tubal ligation or hysterectomy), * post menopausal with a minimum 1 year without menses. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00788697

{ "NCT_ID" : "NCT03604757", "Brief_Title" : "68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks", "Official_title" : "Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Prostate Cancer of Various Metastatic Risks Candidates for Radical Prostatectomy - 'UROPET'", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: 68Ga-PSMA-617 PET/CT", "Drug: 68Ga-RM2 PET/CT"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients with primary prostate cancer (low, intermediate or high metastatic risk) for whom radical prostatectomy is indicated, will be invited to participate to the present study. Positron Emission Tomography coupled with scanner (PET-CT) using a radiotracer : 68Ga-RM2 and Positron Emission Tomography coupled with scanner (PET-CT) using another radiotracer : 68Ga-PSMA-617, will be scheduled. Detailed Description Approximately 15% of men with prostate cancer have high-risk disease at diagnosis. For these patients the accuracy of initial staging is of critical importance for treatment decision-making. Recommended imaging modalities for initial staging include computerized tomography (CT) scan, bone scan, and Magnetic Resonance Imaging (MRI). In addition to initial work-up, 18F-Choline Positron Emission Tomography coupled with scanner (PET-CT) may be proposed in some high-risk patients but its sensitivity for lymph node detection remains limited. Nowadays, new radiotracers are becoming available for prostate cancer imaging. Among them, PET-CT imaging with radiolabeled ligands of prostate specific membrane antigen (PSMA) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as it is the case with radiolabeled PSMA-617 which has demonstrated very promising results in men with metastatic prostate cancer in recent studies. Therefore, PET imaging with 68Ga-PSMA-617 may participate to optimize work-up in the staging of high-risk patients. Another family of radiopharmaceuticals aimed to target the Gastrin-Releasing Peptide Receptor (GRP-R) which is overexpressed in low-grade prostatic carcinomas. GRP-R expression is correlated with androgen receptor expression and with better outcomes. Various radiolabeled GRP analogues have been developed and one of them, 68Ga-RM2, has shown very promising preclinical results. A study in 14 patients with prostate cancer showed encouraging results as related to the detection of primary prostate cancer and metastatic lymph nodes as well as in detection of local recurrence in the prostate bed and nodal relapse. However, 68Ga-RM2 failed to show some bone metastases in hormone-refractory patients. 68Ga-RM2 has also been recently used and compared to 68Ga-PSMA-11 for targeting biochemically recurrent prostate cancer. These radiotracers may offer complementary performances in lymph nodes detection due to their distinct pharmacokinetics. Since 68Ga-RM2 and 68Ga-PSMA-617 target different cell populations, combining these two radiopharmaceuticals in patients could be of additional value. The aim of this pilot study is to compare 68Ga-PSMA-617 PET/CT to 68Ga-RM2 PET/CT in 24 patients with prostate cancer of various progression risks to better understand how they could performed a metastatic risk mapping and how they could be used (or combined) in clinical practice. #Intervention - DRUG : 68Ga-PSMA-617 PET/CT - PET/CT Imaging with 68Ga-PSMA-617 injection - DRUG : 68Ga-RM2 PET/CT - PET/CT Imaging with 68Ga-RM2 injection

#Eligibility Criteria: Inclusion criteria : 24 patients divided in : * 6 patients with low risk prostate cancer (Gleason score <= 6 and cT1-T2a and Prostate Specific Antigen (PSA) value < 10 ng/mL) * 12 patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10 <= age <= 20 ng/mL) divided in : 6 patients who are Gleason score 7(3+4) (favourable intermediate risk) 6 patients who are Gleason score 7(4+3) (unfavourable intermediate risk) * 6 patients with high risk prostate cancer (Gleason > 7 or cT2c or PSA value > 20 ng/mL) * Candidate for radical prostatectomy after discussion in multidisciplinary committee * Covered by the national health insurance system * Written informed consent willingly obtained Exclusion criteria : * any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc...); * patient not candidate for radical prostatectomy and/or unable to benefit from surgery * freedom deprivated patient by judiciary or administrative decision * patient under legal protection or unable to express its own consent * patient within exclusion period from another clinical trial * known contraindication to radiopharmaceuticals and / or excipients Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03604757

{ "NCT_ID" : "NCT00082134", "Brief_Title" : "Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel", "Official_title" : "A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel", "Conditions" : ["Hormone-refractory Prostate Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651. #Intervention - DRUG : ILX651

#Eligibility Criteria: Inclusion Criteria: * Patient has hormone-refractory prostate cancer (HRPC) as evidenced by PSA progression or progression of measurable disease. * Patient has greater than 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week apart. * Patients on androgen deprivation treatment and will continue on androgen deprivation treatment during study participation except for patients who are post orchiectomy. * Patient has evidence of metastatic disease by positive bone scan or evidence of progressive metastatic disease by CT scan. * Patient has been treated with at least 1 prior hormone therapy or is post orchiectomy. * Patient has been previously treated at a minimum for an 8-week treatment period on a docetaxel-based regimen for metastatic HRPC. * Patient has PSA at least 5 ng/mL or greater. * Patient has testosterone less than 50 ng/dL. * Patient ECOG performance status of 0 or 1. * Patient has life expectancy of greater than 8 weeks. * Patient meets lab values: A. Absolute neutrophil count at least 1,500/mm^3 or greater; B.Platelet count at least 100,000/mm^3 or greater; C. Serum creatinine at least 1.5 mg/dL or less or creatinine clearance at least 60 mL/min or greater; D. Bilirubin less than 2.0 mg/dL. E. AST and ALT less or equal to 2.5 times upper limit of normal * Any chemotherapy, major surgery, or irradiation must be completed at least 4 weeks prior to study drug. * Patient recovered from clinically significant toxicities from prior treatment. Exclusion Criteria: * Prior treatment with 2 or more prior chemotherapy regimens. * Concurrent treatment with an estrogen-containing agent including diethylstilbestrol (DES). * Prior flutamide (Eulexin) within past 4 weeks, prior bicalutamide (Casodex) within past 6 weeks, or prior nilutamide (Nilandron) within past 6 weeks. * Prior strontium or samarium or other radioisotope therapy. * Prior radiation therapy to greater than 25% of the bone marrow (e.g., no whole pelvic irradiation is allowed). * Uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment. * Patients with uncontrolled hypertension. * Pre-existing cardiac, pulmonary, neurologic or other disease that would preclude study participation. * Documented untreated central nervous system (CNS) metastases. However, patients with treated CNS metastases that have been stable are eligible. * Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would preclude study participation. * Active secondary malignancy except non-melanoma skin cancers. * Known, active infection, or known HIV positive or presence of an AIDS related illness. Sex : MALE Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00082134

{ "NCT_ID" : "NCT02430298", "Brief_Title" : "Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients", "Official_title" : "Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients", "Conditions" : ["Head and Neck Cancer"], "Interventions" : ["Drug: Melatonin", "Drug: Matched Placebo"], "Location_Countries" : ["Thailand"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H\&N), pain (VAS 0-10) and adverse event frequency. #Intervention - DRUG : Melatonin - Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study - Other Names : - 20 mg/10 ml melatonin suspensions, 20 mg melatonin gelatin capsule - DRUG : Matched Placebo - Drug: Melatonin 20 mg/ 10 ml placebo suspension gargle for 2 minutes before radiation 15 minutes and 20 mg placebo gelatin capsule taken orally after 21:00 hours each night throughout the study - Other Names : - 20 mg/10 ml placebo suspensions, 20 mg placebo gelatin capsule

#Eligibility Criteria: Inclusion Criteria: * New diagnostic of head and neck cancer patient who need treatment with radiation involved with the oral cavity area. * Never received radiotherapy or chemotherapy * Karnofsky performance status > 70% * Stopped smoking * Able to eat and swallow medications * Written informed consent Exclusion Criteria: * Melatonin allergy * Active oral cavity inflammation scar * Pregnancy * Creatinine clearance < 30 ml/min * Active periodontal disease * Steroids or pain killer drugs used for oral cavity pain except NSAIDs for thromboembolism prevention * Currently use benzydamine mouthwash Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT02430298

{ "NCT_ID" : "NCT01129622", "Brief_Title" : "Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)", "Official_title" : "Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: letrozole"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in the breast by letrozole might help better identifying of suspicious areas in the breast and could assist radiologists in distinguishing between benign breast areas and cancer tissue. This might help reducing the rate of call backs and unnecessary biopsies for patients. We expect to enroll 20 healthy postmenopausal women in this study. Detailed Description A breast MRI will be performed in the standard way for diagnosis and to serve as a baseline. A second MRI will be performed within a month and following administration of letrozole 12.5 mg daily for three days to reduce breast estrogen levels and in anticipation of lowering breast gadolinium dye uptake. #Intervention - DRUG : letrozole - Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens. - Other Names : - Femara TM Novartis Pharmaceuticals Canada Inc., Dorval, QC

#Eligibility Criteria: Inclusion Criteria: * Women are eligible to participate if they are >= 40 years and have been menopausal (had no menstrual bleeding during the past 12 months) Exclusion Criteria: * History of bilateral mastectomy, osteoporosis or renal impairment. Sex : FEMALE Ages : - Minimum Age : 40 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT01129622

{ "NCT_ID" : "NCT04137575", "Brief_Title" : "ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence", "Official_title" : "A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors", "Conditions" : ["Fear of Cancer Recurrence", "Breast Cancer Female"], "Interventions" : ["Behavioral: ConquerFear-Group", "Behavioral: Relaxation Training"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary The primary aim of this randomized controlled trial is to evaluate the effect of ConquerFear-Group (CF-G), compared with a control condition (CC), on Fear of Cancer Recurrence (FCR). Secondary aims are to explore the effect of CF-G on emotion regulation and additional psychological outcomes, and to explore mediating effects of emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion. In addition, treatment expectancy, participation in other treatments after completion of the intervention of the study and demographic and clinical variables will be explored as moderators. Detailed Description A randomized controlled trial testing the efficacy of ConquerFear-Group (CF-G) on breast cancer survivors with clinical levels of Fear of Cancer Recurrence (FCR), compared with a control condition (CC), will be conducted. The aims are to: 1. Evaluate the efficacy of CF-G on FCR, 2. Explore the effects on the secondary outcomes of emotion regulation, general distress, health-related QoL, survivors' unmet needs, mindfulness, metacognitions, intervention satisfaction, negative effects of intervention, and sleep. 3. Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators.\* 4. Explore treatment expectancy, participation in other treatments after completion of the CF-G or the CC and demographic and clinical variables as possible moderators. Primary hypothesis: CF-G will yield larger reductions in FCR than CC at post treatment, and the effect will be maintained through the follow-up period. Secondary hypotheses: CF-G will demonstrate a larger improvement in measures of emotion regulation than CC following the intervention period. Changes in emotion regulation during treatment will mediate the effect of CF-G on FCR.\* Changes in metacognitions during treatment will mediate the effect of CF-G on FCR.\* CF-G will yield larger reductions in general distress, health-related QoL, survivors' unmet needs than CC, and CF-G will yield larger improvements in metacognitions, mindfulness, and sleep than CC following the intervention period. \*The prerequesties for conducting for mediation analysis were not fulfilled. Consequently, these analyses were abandoned. Data can be obtained upon request. #Intervention - BEHAVIORAL : ConquerFear-Group - The intervention consist of one 1½-hour individual session in which a psychologist will conduct an oral psychological assessment, and five 2-hour group sessions. The key goals of the intervention are to: a) teach strategies for controlling worry and excessive threat monitoring; b) modify underlying unhelpful beliefs about worry; c) develop appropriate monitoring and screening behaviors; d) educate about follow-up care and empirically-supported behavioral change (e.g., weight loss, exercise, etc.) to improve overall survival; e) address existential changes brought about by a cancer diagnosis; f) promote goal-setting. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition. Four trained psychologists (MSc) will perform the therapy. The intervention will be delivered on Zoom, a secure online platform. - BEHAVIORAL : Relaxation Training - The control group will receive one 1½-hour individual session and participate in five 2-hour group sessions. Patients will receive guided progressive muscle relaxation training. The intervention will be delivered on Zoom, a secure online platform.

#Eligibility Criteria: Inclusion Criteria: * Eligible patients have a confirmed past diagnosis of stage 1 <= age <= 3 breast cancer, * have been treated with curative intent, * have completed all hospital-based adjuvant treatments 3 months to 5 years prior to study entry, * are disease free, * scores in the clinical range (>=22) on the Short Form of the Fear of Cancer Recurrence Inventory (FCRI-SF), * are able to read and write Danish, * are over the age of 18 years, and * are able to give informed consent. Exclusion Criteria: * self-reported current major depression, * currently receiving psychological treatment from a therapist not involved in the study, * self-reported active psychotic illness or other severe psychiatric conditions. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04137575

{ "NCT_ID" : "NCT03328494", "Brief_Title" : "Study of Paclitaxel in Combination With BOS172722 in Patients With Advanced Nonhaematologic Malignancies", "Official_title" : "A Phase 1/1b Study of Paclitaxel in Combination With BOS172722, a Monopolar Spindle 1 Kinase Inhibitor, in Patients With Advanced Nonhaematologic Malignancies", "Conditions" : ["Advanced Nonhaematologic Malignancies"], "Interventions" : ["Drug: Paclitaxel", "Drug: BOS172722"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will be conducted to assess the safety and tolerability of BOS172722 when administered as monotherapy and in combination with paclitaxel in participants with advanced nonhaematologic malignancies and also to establish the maximum tolerated dose and recommended Phase 2 dose of BOS172722 in combination with paclitaxel in those participants. #Intervention - DRUG : BOS172722 - Oral capsules - DRUG : Paclitaxel - IV infusion

#Eligibility Criteria: Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * For Part A only, histopathologically confirmed diagnosis of an advanced nonhaematologic malignancy * For Part B only, histopathologically confirmed diagnosis of triple-negative breast cancer * No standard curative treatment or has declined standard therapy * Eastern Cooperative Oncology Group performance status 0 or 1, measured within 72 hours before the first BOS172722 or paclitaxel dose * Predicted life expectancy of >= 3 months * Adequate renal function (creatinine <= 1.5 × upper limit of normal [ULN] or glomerular filtration rate >= 50 milliliters per minute [mL/min]) * Adequate hepatic function: * Total bilirubin <= 1.5 × ULN * Aspartate transaminase <= 3 × ULN (or <= 5 × ULN if due to liver involvement by tumor) * Alanine transaminase <= 3 × ULN (or <= 5 × ULN if due to liver involvement by tumor) * Adequate bone marrow function: * Hemoglobin >= 9.0 grams per deciliter (g/dL) * Platelet count >= 100 × 10^9 cells per liter (cells/L) * Absolute neutrophil count >= 1.5 × 10^9 cells/L * Mean corrected QT interval as calculated by the Fridericia correction formula < 470 milliseconds * Willingness to use adequate contraceptive methods * Capable of giving signed informed consent * Willingness to avoid direct sunlight and the use of tanning equipment during the study and for at least 30 days after the last BOS172722 dose Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * For Part A combination cohorts and Part B: a history of hypersensitivity to paclitaxel * Persistent clinically significant toxicity from prior chemotherapy > Grade 1, excluding alopecia * Unable to swallow oral capsules * Gastrointestinal (GI) condition which could interfere significantly with the absorption of study medication * History of upper GI bleeding, ulceration, or perforation within 6 months before the first or paclitaxel BOS172722 dose * Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases). (Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants, with no dose change within 28 days before the first BOS172722 or paclitaxel dose, will be allowed.) * History of stroke or cerebrovascular accident within 3 months before the first BOS172722 or paclitaxel dose * Any evidence of serious active infection * Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months before the first BOS172722 or paclitaxel dose, New York Heart Association Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements * Known infection with Human Immunodeficiency Virus or hepatitis A, B, or C (testing not required) * Major surgery within 28 days before the first BOS172722 or paclitaxel dose * Pregnant or breastfeeding * Active treatment for a secondary malignancy * Cancer-directed therapy (chemo-, radio-, immuno-, biologic, or hormonal therapy with the exception of luteinizing hormone-releasing hormone agonists/antagonists, receptor activator of nuclear factor kappa-B ligand inhibitors, and bisphosphonates) within 21 days or 5 half-lives, whichever is longer, before the first BOS172722 or paclitaxel dose (Palliative radiotherapy is allowed before initiating study treatment if any associated toxicity resolved to <= Grade 1.) * Use of a medication known to be a strong or moderate inhibitor or inducer of CYP3A4 within 14 days before the first BOS172722 or paclitaxel dose * Use of a medication known to be a substrate of CYP3A4 and to have a narrow therapeutic range within 14 days before the first BOS172722 or paclitaxel dose * Consumption of grapefruit or Seville oranges (including juice, marmalade, etc.) within 14 days before the first BOS172722 or paclitaxel dose Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03328494

{ "NCT_ID" : "NCT02493972", "Brief_Title" : "Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis", "Conditions" : ["Ovarian Cancer With Peritoneal Carcinosis"], "Interventions" : ["Procedure: GelPort", "Procedure: laparotomy"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Multicenter prospective diagnostic study. #Intervention - PROCEDURE : GelPort - Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability - PROCEDURE : laparotomy - laparotomy will be performed if indication confirmed by manual exploration

#Eligibility Criteria: Inclusion Criteria: * Over 18 years Patient * Woman presenting a peritoneal carcinosis presumed ovarian origin * Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available. * WHO 0 - 2 * Membership in a social security system * Patient having given her written consent Exclusion Criteria: * Male * Contraindication in the coelioscopy * Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study * Patient deprived of freedom, under guardianship or guardianship Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02493972

{ "NCT_ID" : "NCT03032575", "Brief_Title" : "Anal HPV Infection and Risk for Anal High-grade Squamous Intraepithelial Lesion Among Thai MSM With Acute HIV Infection", "Official_title" : "SEARCH Thailand and Thai Red Cross AIDS Research Centre", "Conditions" : ["Human Papillomavirus Infection"], "Interventions" : ["Behavioral: SEARCH010/RV254"], "Location_Countries" : ["Thailand"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary 1. To determine the prevalence and incidence of anal HSIL and associated risk factors among MSM who initiate ART during AHI. Detailed Description Anal human papillomavirus (HPV) infection is very common in men who have sex with men (MSM).1-3 HIV-positive MSM have a higher prevalence of anal HPV infection than HIV-negative MSM and are more likely to have infection with multiple HPV types.1,2 Spontaneous clearance of anal HPV infection is less common among HIV- positive compared with HIV-negative MSM.2 Persistent anal HPV infection, particularly with high-risk HPV types, is an important risk factor for the development of anal cancer.4-6 The incidence of anal cancer among HIV-positive MSM is very high, ranging from 75 to 137 per 100,000 person-years, and is five times higher than that in HIV-negative MSM.7-10 Anal high-grade squamous intraepithelial lesion (HSIL) is the putative precursor of anal cancer.11-13 Anal squamous intraepithelial lesion has a dynamic picture of temporal progression and regression, but HSIL is much less likely to regress than low-grade squamous intraepithelial lesion (LSIL).10,14 A recent systematic review and meta-analysis showed the pooled prevalence of anal HSIL to be 29.1% in HIV-positive MSM and 21.5% in HIV-negative MSM.15 Anal HSIL incidence ranged from 8.5 to 15.4% per year in HIV-positive MSM and 3.3 to 6.0% per year in HIV-negative MSM. Although data are limited, previous studies have shown a 9-15% progression rate from anal HSIL to anal cancer during a median follow-up of 3 - 5 years. 11-13 Previous research at the Thai Red Cross AIDS Research Centre has demonstrated high rates of HPV infection and anal HSIL among Thai MSM, with HIV-positive MSM disproportionately affected. Prevalence of anal infection with high-risk HPV types was 57.5% in HIV-positive and 36.6% in HIV-negative MSM (p = 0.008).16 Prevalence of anal HSIL was 18.9% in HIV-positive MSM and 11.4% in HIV-negative MSM (p = 0.1), while incidence of anal HSIL over 12 months was 29% and 8%, respectively (p=0.001).17 HIV-positive MSM in that study, however, were mainly naïve to antiretroviral therapy (ART) at enrollment (87% not on ART) and only 10% had undetectable HIV viral load at baseline. It is not clear if the higher rates of HPV infection and persistence of infection are due to HIV infection or to different risk behavior among HIV-positive MSM. Data are inconclusive on whether the use of ART has an effect on anal HPV infection among HIV-positive MSM.18-19 Furthermore, there is no data on the effect that 'early diagnosis' of HIV infection and 'early treatment' with ART might have on incidence and persistence of HPV infection or on the development of anal HSIL. We propose a longitudinal, observational study of HPV infection and anal HSIL among HIV-positive Thai MSM who initiate ART during acute HIV infection (AHI). The hypothesis is that early HIV diagnosis and early ART within the first 4 weeks of infection will mitigate immunological and virological factors that increase HPV persistence and anal HSIL incidence in HIV-positive MSM such that these measure will be significantly lower when compared to historical controls of chronically-infected HIV-positive Thai MSM. #Intervention - BEHAVIORAL : SEARCH010/RV254

#Eligibility Criteria: Inclusion Criteria: * Age 18 years or above. * Born biological male. * Self-identifies as MSM or transgender woman. * Enrolled in the SEARCH010/RV254 cohort. * In the stage of acute HIV infection diagnosed within 7 days (Fiebig I-V). * Agrees to start ART during acute HIV infection. * Had sex with a male partner at least once in the previous 3 months * Consents to participate in the study Exclusion Criteria: * Any history of previous HSIL diagnosis or treatment. Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT03032575

{ "NCT_ID" : "NCT02555358", "Brief_Title" : "Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study", "Official_title" : "Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study", "Conditions" : ["Gastric Cancer"], "Interventions" : ["Drug: oxaliplatin,capecitabine", "Drug: docetaxel,0xaliplatin,capecitabine"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "FACTORIAL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients. Detailed Description Eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to three group. The group A wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.The group B wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy.The group C wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy. #Intervention - DRUG : docetaxel,0xaliplatin,capecitabine - docetaxel 60mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2， ivgtt，2h，d1;q21d - Other Names : - AISU,AIHENG,AIBIN - DRUG : oxaliplatin,capecitabine - oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d - Other Names : - AIHENG,AIBIN

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically proven in operable advanced gastric adenocarcinoma; * Subjects who were identified as potentially resectable cases by a multidisciplinary consultation; * KPS> 80; ECOG score: 0 <= age <= 1; * Expected survival> 6 months; * Age 20 -60; * Major organ function has to meet the following criteria: Neutrophil count >=1.5 × 109 / L, platelet count >=100 × 109 / L, Hemoglobin >=90g / L, liver function <1.5 times the upper limit of normal, serum bilirubin <=1.0 × UNL, serum creatinine <1.5 × UNL, PT-INR / PTT <1.7 times the upper limit of normal; * Subjects has to voluntarily join the study and sign the Informed Consent Form for the study; Exclusion Criteria: * Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs; * History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product; * Receiving any form of chemotherapy or other study medication; * Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method; * Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT02555358

{ "NCT_ID" : "NCT03531762", "Brief_Title" : "Effect of a Proton Pump Inhibitor on the PK of Tepotinib", "Official_title" : "Phase I, Open-label, Three-Period Crossover Study to Investigate the Effect of a Proton Pump Inhibitor (Omeprazole) on the PK of Tepotinib in Healthy Subjects", "Conditions" : ["Healthy"], "Interventions" : ["Drug: Omeprazole", "Drug: Tepotinib"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary This study was investigated in healthy participants (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and tolerability of tepotinib alone and upon co-administration of omeprazole. #Intervention - DRUG : Tepotinib - Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C. - DRUG : Omeprazole - Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.

#Eligibility Criteria: Inclusion Criteria: * Healthy participants of non-child bearing potential * Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2) * Body weight between 50 to 100 kilogram (kg) * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participation in a clinical study within 60 days prior to first drug administration * Whole blood donation or loss of greater than (>) 450 milliliter (mL) within 60 days prior to first drug administration * Any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation * Other protocol defined exclusion criteria could apply Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03531762

{ "NCT_ID" : "NCT01462396", "Brief_Title" : "Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using MHC Mismatched Related Donors", "Official_title" : "Phase I Study of Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using Major Histocompatibility Complex (MHC) Mismatched Related Donors and Sub-Myeloablative Regimen", "Conditions" : ["Neuroblastoma"], "Interventions" : ["Device: CD34+ cells selected with the Miltenyi Clinimacs machine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DEVICE_FEASIBILITY", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Allogeneic stem cell transplantation has been explored for patients with high risk neuroblastoma. Results have been mixed, with only small series and case reports. Recent reports, however, especially with haploidentical transplantation have been more encouraging. Eradication of neuroblastoma may be mediated by both components of the innate immune system (natural killer cells) and through the adaptive immune system via T-cell cytotoxicity and the development of a humoral response to tumor specific antigens and minor histocompatibility antigens. To overcome restrictions created by unavailability of Human leukocyte antigen (HLA) matched donors, stem cell grafts from haploidentical related donors have been explored. Historically, the use of full haplotype mismatched family member donors has been limited by the development of severe graft-versus-host disease and the high rate of graft failure. Graft failure can now be overcome by increasing immunosuppression and increasing the number of transplanted stem cells. The most effective means of graft versus host disease (GVHD) prophylaxis is T cell depletion of the donor marrow. A 3-4 log depletion will reduce the risk of developing significant GVHD to less than 10%. Methods to mobilize stem cells from the bone marrow into the peripheral blood and collect these stem cells by apheresis now increase the availability of stem cells by a magnitude. Selection devices have been developed that will prepare extremely pure populations of these CD34 cells with upwards of 5 logs depletion of contaminating T cells. The CliniMACS CD34 Reagent System is a medical device designed to select CD34+ hematopoietic cells from heterogeneous hematologic cell populations. The investigators intend to provide mismatched related hematopoietic stem cell transplantation to up to 10 patients with relapsed refractory neuroblastoma. Harnessing the potential for innate and adaptive immune responses through allogeneic Hematopoietic stem cell transplantation (HSCT) may provide cure for some patients with this tumor. #Intervention - DEVICE : CD34+ cells selected with the Miltenyi Clinimacs machine - Haploidentical allogeneic stem cell transplant following sub-myeloablative conditioning and cell selection using the Miltenyi Clinimacs device

#Eligibility Criteria: Inclusion Criteria: * Age 6 months - <18 years * Measurable tumor by routine imaging or bone marrow biopsy * Patient must have an 3/6, 4/6, or 5/6 human leukocyte antigen (HLA)-mismatched related donor who is Epstein-Barr virus (EBV) seropositive * Karnofsky score 60% or greater if 10yrs old or older, Lansky score 60% or greater if under 10yrs old * Pulse ox >90% on room air * Recovered from toxic effects of prior chemotherapy * Patient must not be pregnant * Patient must be HIV negative * Patient or responsible person must be able to understand and sign an informed consent * Available donor without contraindication for stem cell collection Exclusion Criteria: * Pregnant and lactating women. * Human immunodeficiency virus (HIV) positive patient. * Uncontrolled intercurrent infection. * Renal failure (Creatine > 1.5 or Creatinine Clearance < 40 ml/min/1.73m2) * Active hepatitis or cirrhosis with liver test values greater than 3 times normal * NOTE: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion, after review by the Children's Mercy Hospital ethics board * Donor Inclusion/Exclusion Criteria * Donor must be in good health based on review of systems and results of physical examination, and routine testing per standards of good medical care. * Female donors of childbearing age must have a negative pregnancy test and must not be lactating * EBv seropositive * Donor stem cells should be human leukocyte antigen (HLA) typed using molecular methods. See section 6.1.3 for HLA matching requirements. Sex : ALL Ages : - Minimum Age : 6 Months - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT01462396

{ "NCT_ID" : "NCT01234740", "Brief_Title" : "Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases", "Official_title" : "BAFETINIB-P1-GBM-01: A Pilot Study Using Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Bafetinib in Patients With Recurrent Brain Tumors", "Conditions" : ["Adult Anaplastic Astrocytoma", "Adult Anaplastic Ependymoma", "Adult Anaplastic Oligodendroglioma", "Adult Giant Cell Glioblastoma", "Adult Glioblastoma", "Adult Gliosarcoma", "Adult Mixed Glioma", "Recurrent Adult Brain Tumor", "Tumors Metastatic to Brain", "Adult Anaplastic Oligoastrocytoma"], "Interventions" : ["Other: liquid chromatography", "Drug: bafetinib", "Procedure: microdialysis", "Other: pharmacological study", "Other: immunohistochemistry staining method", "Other: mass spectrometry", "Genetic: western blotting", "Procedure: therapeutic conventional surgery", "Genetic: protein expression analysis", "Other: laboratory biomarker analysis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent high-grade glioma or brain metastases. Detailed Description PRIMARY OBJECTIVES: I. To determine the neuropharmacokinetics (nPK) and systemic levels of bafetinib in patients with recurrent malignant brain tumors. SECONDARY OBJECTIVES: I. To investigate the intrapatient variability of nPK parameters as assessed by intracerebral microdialysis. II. To document the toxicity of bafetinib in this cohort of patients. III. To describe the response rate, progression-free survival, and overall survival in patients with malignant brain tumors treated with bafetinib. IV. To assess for the expression of Lyn and Fyn kinases and phosphorylation status in pre-treatment tumor samples. OUTLINE:Patients undergo intracerebral microdialysis during debulking craniotomy or stereotactic biopsy. Beginning 24 hours later, patients receive oral bafetinib twice daily for 1 day. Beginning at least 2 weeks after craniotomy or 1 week after biopsy, patients continue to receive oral bafetinib twice daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 8 weeks thereafter. #Intervention - DRUG : bafetinib - Given orally - Other Names : - dual Bcr-Abl/Lyn tyrosine kinase inhibitor INNO-406, INNO-406, NS-187 - PROCEDURE : microdialysis - Catheter placed intracerebrally during debulking craniotomy or stereotactic biopsy - OTHER : pharmacological study - Correlative studies - Other Names : - pharmacological studies - OTHER : liquid chromatography - Correlative studies - Other Names : - LC - OTHER : mass spectrometry - Correlative studies - OTHER : laboratory biomarker analysis - Correlative studies - GENETIC : protein expression analysis - Correlative studies - GENETIC : western blotting - Correlative studies - Other Names : - Blotting, Western, Western Blot - OTHER : immunohistochemistry staining method - Correlative studies - Other Names : - immunohistochemistry - PROCEDURE : therapeutic conventional surgery - debulking craniotomy

#Eligibility Criteria: Inclusion Criteria: * Patients must have radiographic findings consistent with either: * Recurrent high-grade glioma, or * Metastatic disease to the brain that has progressed after treatment with whole brain radiation therapy or stereotactic radiosurgery; patients who have a resectable brain metastasis as the only site of disease (i.e., no evidence of systemic disease), are not eligible to participate * Patients who are in need of a surgical debulking or a stereotactic biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy will be eligible to participate in the microdialysis part of the study prior to beginning cycle 1 of bafetinib if the study neurosurgeon thinks there is a likelihood of being able to place the microdialysis catheter into residual tumor (enhancing brain tissue) * Patients who choose not to participate in the microdialysis part of the study may enroll in the study and start treatment at cycle 1 of bafetinib * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for 3 months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * Patients must have a Karnofsky Performance Status (KPS) >= 60% * If corticosteroids are required for controlling cerebral edema, patients must be on a stable dose for at least 1 week prior to enrollment * Patients must not be taking any hepatic enzyme-inducing anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) for at least 2 weeks prior to enrollment * Absolute neutrophil count >= 1500 cells/mm^3 * Platelet count >= 100,000 cells/mm^3 * Total bilirubin =< 2.0 mg/dl * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 times the institutional upper limit of normal * Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3 times the institutional upper limit of normal * Serum creatinine =< 1.5 x the institutional upper limit of normal * QTc interval < 480 msec on electrocardiogram (ECG) * All subjects must have the ability to understand and the willingness to sign a written informed consent * Patients must have recovered from any toxicity of prior therapies (including brain radiation); an interval of at least 6 weeks must have elapsed since the completion of a nitrosourea-containing chemotherapy regimen; patients who have undergone a recent craniotomy cannot begin bafetinib until at least 2 weeks after the surgery Exclusion Criteria: * Patients who are currently receiving chemotherapy or are enrolled in another treatment clinical trial * Patients with a coagulopathy or bleeding disorder * Patients on anticoagulant drug therapy or medications that inhibit platelet function, such as ibuprofen or other non-steroidal anti-inflammatory drugs * Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines * Clinically significant cardiac arrhythmias * Patients taking a drug that can prolong the QT interval; if a potential study patient is taking one of the prohibited drugs but s/he can safely stop it, then a washout period of >= 7 days is required prior to starting bafetinib * History or signs of active coronary artery disease with or without angina pectoris * Patients who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol or may not be able to comply with the safety monitoring requirements of the study * Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral therapy are excluded from the study due to the possibility of pharmacokinetic (PK) interactions with bafetinib; however, patients will not be routinely screened for HIV * Female patients who are pregnant or breast-feeding * Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals * Patients who have not recovered from the toxicities of prior chemotherapy or radiotherapy Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01234740

{ "NCT_ID" : "NCT00312429", "Brief_Title" : "Umbilical Cord Blood Stem Cell Transplantation in Adults With Advanced Blood Disorders or Cancer", "Official_title" : "Cord Blood Transplantation in Adult Recipients", "Conditions" : ["Hematologic Neoplasms"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Umbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this procedure in adults. The purpose of this study is to examine the immune system response to cord blood stem cell transplantation in adults with advanced blood disorders or cancer. Detailed Description The use of umbilical cord blood stem cells to treat blood disorders and cancer is an important medical advance; currently, more than 45 disorders can be treated with this method. While bone marrow transplants are the most common method for stem cell donations, research has shown that there are many advantages to using allogeneic grafts of stem cells obtained from umbilical cord blood. Cord blood stem cells are relatively easy to obtain. Additionally, a perfect donor match is not necessary, thereby decreasing the likelihood of graft-versus-host disease (GVHD), a serious side effect in which donor stem cells attack the recipient's tissues. Cord blood has been used successfully in pediatric patients but its benefit in adults remains untested. The purpose of this study is to evaluate the effectiveness of umbilical cord blood stem cell transplantation in adults with advanced blood disorders or cancer. Upon receiving an allogeneic stem cell transplant using umbilical cord blood, participants will be observed for successful engraftment in which the transplanted stem cells 'take' and begin producing new blood cells. The incidence of GVHD and the overall immune system's response will also be examined. In turn, these findings may guide future umbilical cord blood stem cell clinical trials. This 1-year study will enroll individuals with advanced blood diseases or cancer. Participants will receive an allogeneic umbilical cord blood stem cell transplant and will be closely monitored while in the hospital to determine when engraftment occurs and if GVHD develops. Study visits will occur at Months 1, 2, 3, 6, 9, and Year 1. At each visit, participants will have blood drawn for laboratory testing and for evaluation of immune system response. Quality of life questionnaires will also be completed at each visit. #Intervention - PROCEDURE : Stem Cell Transplantation - Allogeneic umbilical cord blood stem cell transplant

#Eligibility Criteria: Inclusion Criteria: * Diagnosis reviewed at transplant center and confirmed to fit the criterion for high risk blood disease or cancer, as defined for the study * Estimated life expectancy of at least 6 weeks following study entry * Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2 * White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results reviewed by transplant center * Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT) performed and reviewed by transplant center (for individuals with an ejection fraction and diffusing capacity [DLCO] of 40 <= age <= 50%, the appropriate cardiology or pulmonary consultations should be considered if the individual has severe heart or lung disease at the initiation of therapy) * Sufficient number of umbilical cord blood units available for transplantation * If female, willing to use contraception throughout the study Exclusion Criteria: * Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry * Diagnosed with a medical or psychiatric illness that may interfere with study participation * Pregnant Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00312429

{ "NCT_ID" : "NCT01700959", "Brief_Title" : "Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort", "Official_title" : "Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort", "Conditions" : ["Cancer Malignancies"], "Interventions" : ["Drug: melatonin", "Drug: placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Primary objective: 1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer. Secondary objectives: 1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors. 2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors. This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep. Detailed Description All participants undergo a general neurocognitive evaluation at baseline and 6-month follow-up, focused on assessment of intelligence, academic skills, attention, processing speed, memory and executive functions. Sleep parameters using self-report and actigraphy will be assessed at three time points during the study: Baseline, 3-months, and 6-months. Participants will be divided into 3 mutually exclusive groups: * Cohort 1: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes less than once a week during the past month. * Cohort 2: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes at least once a week during the past month. * Cohort 3: Participant is absent of neurocognitive impairment defined as performance \>10th percentile on all six measures of attention, memory, and executive functioning, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes \> once a week during the past month. Within each group, participants will be randomly assigned to take either 3 mgs of time release melatonin or placebo 1-2 hours before bedtime each night for 6 months. Psychosocial measures of health-related quality of life and psychological distress will be completed at baseline and following 6 months of melatonin/placebo treatment. Biological samples for serum melatonin levels will be collected at baseline and at the 6 month follow-up evaluation. #Intervention - DRUG : melatonin - Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night. - Other Names : - N-Acetyl-5-Methoxytryptamine - DRUG : placebo - Placebo tablets to match the melatonin will be comprised of inert substances.

#Eligibility Criteria: Inclusion Criteria: * A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital * 10 or more years from diagnosis * 18 years or older * Able to speak and understand the English language * Participant has a full scale intelligence quotient (FSIQ) score >79. * Cohort 1 participant: * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning <=10th percentile. * Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes < once a week during the past month. * Cohort 2 participant: * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning <=10th percentile. * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes >= once a week during the past month. * Cohort 3 participant: * Is absent of neurocognitive impairment defined as performance >10th percentile on all six measures of attention, memory, and executive functioning. * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes >= once a week during the past month. * Female participant of childbearing age must not be pregnant or lactating * Female research participant of childbearing age and male research participant of child fathering potential agrees to use safe contraceptive methods Exclusion Criteria: * Known allergy to melatonin or any ingredients of the study product or placebo * Participant currently is taking melatonin * Known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome) * Known diabetes mellitus - insulin treated * Participant has uncontrolled seizure disorder in past 12 months * Reported current illicit drug or alcohol abuse or dependence * Reported current major psychiatric illness (i.e. schizophrenia, bipolar disorder) * Current treatment with: (1) benzodiazepines or other central nervous system depressants, (2) fluvoxamine, (3) anticoagulants (e.g. coumadin), (4) immunosuppressant or corticosteroids, OR (5) nifedipine (Procardia XL(R)) * Employed in a position that requires night work (i.e. 10pm to 6am) * Females who are pregnant or lactating/nursing * History of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment * Sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01700959

{ "NCT_ID" : "NCT00083538", "Brief_Title" : "Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally", "Official_title" : "UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients", "Conditions" : ["Multiple Myeloma"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses. Detailed Description This is an experimental treatment that will consist of receiving special white blood cell administrations either underneath the skin or in the lymph nodes. In this protocol, treatment will be given according to the 'risk group'. If there are certain abnormalities in the chromosomes, the disease is considered to be high risk. High-risk patients will first receive one cycle of chemotherapy with a regimen called DT PACE, after which the white blood cells will be collected. Leukapheresis is a procedure in which blood is removed, white blood cells are saved, and the remaining blood is given back to you. These dendritic cells will then be mixed with your individual myeloma protein and/or cells, and keyhole limpet hemocyanin (KLH) that is necessary for the enhancement of immune response against myeloma antigens. It is hoped that this will cause these cells to interact with and activate T cells, which will then destroy myeloma cells in your body. Half of these white cells will be injected into your lymph nodes (intranodally) and half will be given subcutaneously. High risk patients will receive a chemotherapy regimen called DT PACE. #Intervention - DRUG : Dexamethasone - DRUG : Thalidomide - DRUG : Cisplatinum - DRUG : Adriamycin - DRUG : Cyclophosphamide - DRUG : Etoposide

#Eligibility Criteria: Inclusion Criteria: * Patients must have confirmed diagnosis of one of the following: Smoldering or indolent multiple myeloma, Multiple myeloma more than 1 year after autologous transplant and with stable disease, or Multiple myeloma with cytogenetic abnormalities * Patients with secretory IgA or IgG must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available * Karnofsky performance score greater than or equal to 60 * ANC greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and CD4 count greater than or equal to 400/microliters. * Expected survival of 3 months or more * 18 years and older * Have given a written consent and been informed about the investigational nature of the study. * Negative serology for HIV, Hepatitis C, and negative for hepatitis B surface antigen Exclusion Criteria: * Patients with CD4 count < 400/microliters, and/or with severely damaged immune functions * Chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks * Fever or active infection * Liver function: total bilirubin greater than or equal to 2 x ULN or AST/ALT greater than or equal to 3 x ULN * Renal function: Patients on dialysis * Simultaneous treatment with a second investigational drug or biologic agent Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00083538

{ "NCT_ID" : "NCT01600339", "Brief_Title" : "A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC)", "Official_title" : "A Single Arm, Multicenter, Open-label Phase II Trial of Cabazitaxel as Second Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma", "Conditions" : ["Urothelial Carcinoma"], "Interventions" : ["Drug: CABAZITAXEL"], "Location_Countries" : ["Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In this phase II multicenter study, the investigators aim to evaluate the efficacy and tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for metastatic urothelial carcinoma. Detailed Description For those patients with advanced bladder cancer who have progressed on a platinum based regimen, no widely accepted standard second line therapy currently exists. Taxanes including paclitaxel and docetaxel have exhibited limited clinical activity in this disease and are sometimes given off study. Cabazitaxel is a novel semi-synthetic taxane with a low affinity for the multidrug resistance 1 protein. In cell lines cabazitaxel is as potent as docetaxel, but in tumor cells that are resistant to taxanes, cabazitaxel overcome taxanes resistance. In recent clinical data, this drug was shown to have potent activity in patients with metastatic prostate cancer resistant to docetaxel. Based on this phase III data, cabazitaxel was recently approved in the US, Europe and in Israel for these patients. The main toxicity of this taxane is neutropenia and diarrhea, thus primary prevention with GCSF may reduce the main toxicity of this agent. In this phase II multicenter study, the investigators aim to evaluate the efficacy and tolerability of this novel taxane -cabazitaxel as single agent second-line chemotherapy for metastatic urothelial carcinoma after failure of prior platinum-based chemotherapy. The patients are planned to receive cabazitaxel at a starting dose of 25 mg/m(2) intravenously over 1 h, following premedication as accepted with cabazitaxel. Treatment cycles are every 3 weeks. All patients will receive primary GCSF support. #Intervention - DRUG : CABAZITAXEL - The patients are planned to receive cabazitaxel at a starting dose of 25 mg/m(2) intravenously over 1 h, following premedication as accepted with cabazitaxel. Treatment cycles are every 3 weeks. All patients will receive primary GCSF support.

#Eligibility Criteria: Inclusion Criteria: * Ages eligible for this study are 18 years and older. * Histological or cytological diagnosis of urothelial carcinoma. Mixed histologies are permitted as long as transitional cell carcinoma is the major component (i.e. > 50% of the pathologic specimen). Pure or predominant squamous cell carcinomas are not permitted. * Patients with transitional cell carcinomas of the renal pelvis and ureter are permitted. * Patients must have metastatic or locally advanced unresectable disease. * Patients must have received one and only one prior chemotherapeutic regimen which included platinum (at least one cycle) for metastatic/recurrent disease. Neoadjuvant or adjuvant chemotherapy will be considered to have been first line if the patient progressed within 12 months of the last dose. * Patients with disease progression more than 12 months following platinum based chemotherapy can be included (rather than platinum re-challenge), according to the investigator's judgment. * ECOG performance status <= 2 * Estimated life expectancy of > 12 weeks. * Patients must have measurable disease according to RECIST1.1 criteria. * If female of childbearing potential, pregnancy test is negative within 8 days priors to first dose of study drug. * If fertile, patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study. * Adequate organ function; Absolute neutrophil count >=1.5 x 109/L. Platelet count >= 100 x109/L. Hemoglobin >= 9 g/dL. Total bilirubin <=1.0x upper limit of normal. AST/SGOT and/or ALT/SGPT <= 2.5x upper limit of normal. Calculated creatinine clearance > 40 ml/min (creatinine clearance will be calculated according to CKD-EPI formula: http://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr).(27) * Able to give informed consent. Exclusion Criteria: * Prior taxane therapy. * Pregnant or lactating females * Uncontrolled brain or leptomeningeal involvement (treated brain metastasis permitted if both known lesions and medications e.g. steroids for that indication are stable). * History of serious or concurrent illness that might be aggravated by study treatment. * Known human immunodeficiency virus (HIV) infection or active hepatitis B/C. * History of class II-IV congestive heart failure. * Significant renal impairment. * Uncontrolled hematuria. * History of severe hypersensitivity reaction (>=grade 3) to docetaxel. * History of severe hypersensitivity reaction (>=grade 3) to polysorbate 80 containing drugs. * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix). * Other malignancies except adequately controlled basal cell carcinoma of the skin or carcinoma in situ of the cervix or incidental prostate cancer (T1a, Gleason < 7 PSA < 10ng/ml) or any other tumor within 2 years prior to enrollment. * Other investigational therapy or radiation therapy within 30 days before registration. * Patients not willing to employ adequate contraception for the duration of the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01600339

{ "NCT_ID" : "NCT00970138", "Brief_Title" : "Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer", "Official_title" : "A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma", "Conditions" : ["Gastric Carcinoma"], "Interventions" : ["Drug: apatinib tablet"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy. Detailed Description Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the promising results of apatinib in the phase I study, this clinical trial has been designed to evaluate whether apatinib can improve progression free survival in patients with metastatic gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg qd, one group patients will receive apatinib 425mg bid, and the other group will receive placebo. #Intervention - DRUG : apatinib tablet - A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

#Eligibility Criteria: Inclusion Criteria: * >= 18 and <= 70 years * Histologically confirmed advanced or metastatic adenocarcinoma of the stomach * Have failed for 2 lines of chemotherapy * Life expectancy of more than 3 months * ECOG performance scale <= 2 * At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan) * Duration from the last therapy is more than 6 weeks for nitroso or mitomycin * More than 4 weeks for operation or radiotherapy * More than 4 weeks for cytotoxic agents or growth inhibitors * Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 109/L, neutrophil > 2.0 × 109/L, serum creatinine <= 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase<=2.5×the ULN). Exclusion Criteria: * Pregnant or lactating women * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Any factors that influence the usage of oral administration; Evidence of CNS metastasis * History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure * Receiving the therapy of thrombolysis or anticoagulation * Abuse of alcohol or drugs * Allergy to the ingredient of the agent or more than two kinds of food and drug * Less than 4 weeks from the last clinical trial * Disability of serious uncontrolled intercurrence infection. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00970138

{ "NCT_ID" : "NCT03450044", "Brief_Title" : "Immunogenicity and Safety of DCs in Breast Cancer", "Official_title" : "Immunogenicity and Safety of Autologous Dendritic Cells in Patients With Breast Cancer Treated With Neoadjuvant Chemotherapy.", "Conditions" : ["Breast Cancer Female"], "Interventions" : ["Biological: Dendritic cells"], "Location_Countries" : ["Colombia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study aims to evaluate for the first time in Colombia the immunogenicity and safety of autologous DCs as enhancers of the immune response in patients with ductal breast cancer who, prior to surgical resection of the tumor, will receive neo-adjuvant chemotherapy with Doxorubicin and Cyclophosphamide. concomitantly with the transfer of autologous DCs. This clinical trial is based on the concept proposed in countries like France more than a decade ago, that chemotherapy or radiotherapy cause the tumor cells to release certain signals that favor the activation of the immune system against cancer. Therefore, the combined use of chemotherapy with vaccination with dendritic cells would provide the immune system with greater antitumor response capacity, taking advantage of the release of said signals to initiate a series of processes that would be reflected in the activation of T lymphocytes capable of destroying the remaining cells of the tumor. To determine the specificity of the response evoked by the adoptive transfer of autologous DCs, in each patient the degree of recognition of the tumor by the immune system before and after said procedure will be evaluated. These results will be compared with those of patients who participated in a control group. Hypothesis Adoptive transfer of autologous DCs generated in vitro, in patients with stage IIA-IV breast cancer who receive neoadjuvant therapy with Doxorubicin and Cyclophosphamide, is a safe procedure that stimulates anti-tumor immune responses in treated patients. Principal aim: To evaluate the safety and immunogenicity of the use of DCs when used in patients with stage IIA-IV breast cancer in association with neo-adjuvant chemotherapy with Doxorubicin/Cyclophosphamide. Specific aims: * Generate immuno-competent dendritic cells in conditions of Good Clinical Practice and Good Laboratory Practices. * Determine in each patient the immunological status of specific T lymphocytes against tumor antigens, before and after chemotherapy, in order to demonstrate whether the adoptive transfer of DCs favors the anti-tumor immune response. * Register in patients with breast cancer in neo-adjuvant chemotherapy the class and frequency of adverse effects that could be generated as a result of the adoptive transfer of autologous DCs. Detailed Description The Fundación Salud de los Andes in the framework of a strategic alliance with the National University of Colombia has been working in the planning and development of a clinical trial in Colombia that promotes the search for new therapeutic alternatives for cancer patients. As a translational medicine project, it aims to make the laboratory findings available to the patient. This study explores the combination of immunotherapy (cell therapy) with chemotherapy, in order to obtain better results in the therapeutic management of tumors in patients with breast cancer. Problem: Breast cancer is a pathology that in recent years has increased vertiginously its incidence globally. Given the advanced state in which this tumor is usually diagnosed in our environment, the prognosis is seriously compromised, which has led to the current breast cancer represents a major public health problem in Colombia. The established therapies for the management of patients with this type of tumors such as chemotherapy, radio-therapy or surgery, are effective to reduce much of the established tumor mass, but fail to eliminate residual cancer cells, so - often - these treatments cannot prevent the recurrence of the disease. In addition to the above, the quality of life of the patients treated is strongly affected by the toxicity of these treatments on healthy tissues and their undesirable effects, which frequently affects poor adherence to treatment. That is why it is necessary to search for new therapeutic alternatives that are more specific to the tumor and that are better tolerated by patients. Due to the high specificity of the immune system for the recognition of tumors, different modalities of immune therapy for tumor control are currently being explored, which seek to enhance the performance of the patient's defense system so that a cytotoxic and memory response is established against them. tumor cells. Type of study Clinical Trial Phase I / II. Methodology: Patients who attend the consultation due to their mammary pathology for the start of neo-adjuvant chemotherapy will be pre-selected to participate in the study. The participation of the volunteers will be subject to compliance with the inclusion and exclusion criteria defined for the study, as well as the signing of the informed consent. The participants will be randomly distributed into two groups. PATIENT GROUPS As part of the clinical evaluation at the entrance of the study, a battery of laboratory tests (basic and specific to the trial) will be carried out. Subsequent to the corroboration of compliance with the inclusion criteria, patients will be randomly assigned to one of the two study groups: The first group (A) will be the negative control group, which includes patients who will receive only the standardized chemotherapy treatment for the pathology. The second group (B) will consist of those patients who were randomly selected to receive the adoptive transfer of mature autologous DCs in combination with the neo-adjuvant chemotherapy. In this way, the total of 30 patients will be distributed as follows: 15 patients for group A and 15 patients for group B. The patients of group B will undergo an apheresis procedure in order to obtain a sample enriched in peripheral blood monocytes from which monocytes will be purified for the production of DCs. The generation of DCs will be carried out under strict conditions of Good Clinical Practices and Good Laboratory Practices. The adoptive transfer will be carried out concomitantly with the neo-adjuvant chemotherapy treatment (eight and 15 days after chemotherapy dose for a total of 6 injections with autologous DCs). In the period of application of the doses, a permanent clinical evaluation will be carried out to the patients, to register possible adverse effects (evaluation of the safety of the adoptive transfer of autologous DCs). The effect on the immune response of autologous DCs transferred to patients on chemotherapy vs. the effect on the immune response of chemotherapy without transfer, will be analyzed in each patient before and after chemotherapy using the state of the art of immunological techniques with which will measure the extent of anti-tumor CD8+ T cells expansion (evaluation of the immunogenicity of the adoptive transfer of autologous DCs). Participating Institutions: Fundación Salud de los Andes Research Group in Immunology and Clinical Oncology - GIIOC National University of Colombia - Bogotá. School of Medicine Immunology and Translational Medicine Group Departments of Microbiology and Pathology Other collaborating institutions: Clínica del Seno Hospital Universitario Nacional Instituto Nacional de Cancerología Oncocare #Intervention - BIOLOGICAL : Dendritic cells - Adoptive transfer of autologous DCs

#Eligibility Criteria: Inclusion criteria: * Women between 30 and 65 years. * Patients who have histologically confirmed primary invasive ductal carcinoma of the breast. * Patients who, at the time of their evaluation, present a breast cancer with TNM classification: IIA, IIB, IIIA, IIIB, IIIC or IV; in whom the breast-tumor relationship is not satisfactory for the surgical procedure, so that they will receive neo-adjuvant chemotherapy with Doxorubicin and Cyclophosphamide for at least 3 cycles. * Patients who voluntarily agree to enter the proposed immunotherapy scheme. * Absence of second malignant disease with the exception of a cervical carcinoma or a treated basal cell carcinoma. * Normal blood, kidney function and hepatic function (neutrophil count 1000 / mm3, lymphocyte count 500 / mm3, hemoglobin 8mg / dl, and platelet count 150,000 / mm3, serum creatinine 1.5mg / dl, BUN 50mg / dl, aminotransferases 2 times of normal value and bilirubin 2.0mg / dl). * Karnofsky higher than 70% or ECOG 0 to 1. * Life expectancy greater than three months. * Ability to understand informed consent. * Have a weight greater than 50 Kilos at the time of apheresis. Exclusion criteria: * Patients who are pregnant or breast-feeding. * Patients who have received some type of therapy as treatment for their tumor pathology in the breast, prior to the start of the trial (radiotherapy, chemotherapy, immunotherapy or gene therapy). * Metastasis to the central nervous system at the time of inclusion in the study. * Active autoimmune disease requiring treatment or history of autoimmune disease, which could be exacerbated by treatment. Patients with endocrine disease controlled by replacement therapy may be included, including thyroid disease, adrenal disease and vitiligo. * Presence of a chronic or acute infection, such as HIV, viral hepatitis or tuberculosis, before or after the signing of the informed consent. * Use of immunosuppressant within 4 weeks prior to the trial (eg corticosteroids), such as azathioprine, prednisone or cyclosporine A. The use of local steroids (topical, nasal or inhaled) may be acceptable. * Patients with eczema, history of eczema or other eczematous skin disorders or those with acute or chronic exfoliative skin condition (eg atopic dermatitis, burns, impetigo, varicella zoster, severe acne or open wounds). * Any disease that could interfere with the patient's ability to carry out the treatment (eg, Crohn's disease, ulcerative colitis or active diverticulitis, severe respiratory, cardiovascular, neurological, infectious disease or uncontrolled metabolic disease), including diseases of the psychiatric type. * Clinically significant cardiomyopathy, which requires treatment. * Splenectomized patients. * Patients who do not receive the neo-adjuvant chemotherapy regimen with Doxorubicin and Cyclophosphamide for three cycles. * Patients who have had an excisional biopsy. Sex : FEMALE Ages : - Minimum Age : 30 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03450044

{ "NCT_ID" : "NCT02740127", "Brief_Title" : "Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis", "Official_title" : "Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery", "Conditions" : ["Malignant Neoplasms of Male Genital Organs"], "Interventions" : ["Procedure: Caudal Nerve Block (CNB)", "Drug: Epinephrine", "Drug: Decadron", "Drug: Ropivacaine", "Behavioral: Phone Call", "Drug: Propofol", "Drug: Clonidine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs. The goal of this clinical research study is to learn how effective CNBs are in patients who are having penile prosthesis surgery compared to patients who only have general anesthesia by studying how long you stay in the hospital and the level of pain you have after surgery. This is an investigational study. The general anesthesia and CNB used in this study are FDA approved and commercially available. It is considered investigational to compare the effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study doctor can explain how the study drugs are designed to work. Up to 104 participants will be enrolled in this study. All will take part at MD Anderson. Detailed Description Study Groups and CNB Administration: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group. * If you are assigned to Group 1, you will receive a CNB and general anesthesia during surgery. * If you are assigned to Group 2, you will only receive general anesthesia during surgery. You will not know to which group you have been assigned. The CNB will be given to you while you are under general anesthesia. To receive a CNB, a special needle is inserted at the lower part of the back (near the tailbone). A type of local anesthesia is then injected into the sac surrounding the spinal cord that contains the nerves related to the penis. All participants will also receive general anesthesia as part of their standard care. You will also receive a separate consent form for the surgery that explains the procedure and its risks, including the risks for general anesthesia. After Surgery Data Collection: During the 24 hours after surgery, the study staff will ask you to rate your pain on a scale of 0-10. You will be asked to rate your pain about every 30 minutes while you are in the hospital, but you may be asked to rate your pain more often if needed. It should take less than 5 minutes each time to rate your pain. Depending on how you rate your pain, additional pain drugs may be given to you as part of your standard care. If you are discharged from the hospital on the same day as your surgery or if you are discharged before a member of the staff can ask you to rate your pain, the study staff will call you within 24 hours after you have been discharged from the hospital. This call should last about 5-10 minutes. The amount of pain drugs given to you before, during, and after surgery will also be recorded. About 3 days after your surgery, the study staff will call you to ask about your pain, the amount of pain drugs you have taken, and how satisfied you are with the type of anesthesia and pain control you have received. This call should last about 5-10 minutes. Length of Study: Your participation in this study will be over after the phone call about 3 days after your surgery has been completed. #Intervention - PROCEDURE : Caudal Nerve Block (CNB) - General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg. - DRUG : Ropivacaine - Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR. - Other Names : - Naropin - DRUG : Epinephrine - Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR. - DRUG : Decadron - Decadron 10 mg by bolus injection given by anesthesiologist in OR. - Other Names : - Dexamethasone - DRUG : Clonidine - Clonidine 100 mcg by bolus injection given by anesthesiologist in OR. - DRUG : Propofol - General anesthesia given in the OR using Propofol titrated for induction. - Other Names : - Diprivan - BEHAVIORAL : Phone Call - Study staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes.

#Eligibility Criteria: Inclusion Criteria: * Patients that consent to participate. * Patients undergoing penile prosthesis surgery. * Patients that are male. * Patients that are 18 years or older. Exclusion Criteria: * Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs. * Patients with a BMI > 40. * Patients with chronic pain syndromes. * Patients with hypersensitivity to Ropivacaine/amide-type anesthetics. * Prior surgery of the sacrum. * Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames: i) Low molecular weight heparin less than 36 hours prior to surgery. ii) Coumadin less than 5 days prior to surgery. iii) Plavix and NSAIDs less than 7 days prior to surgery. * Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic pain management less than 24 hours prior to surgery * Patients on Celebrex less than 24 hours prior to surgery * Patients taking more than 81 mg of Aspirin daily Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02740127

{ "NCT_ID" : "NCT01010061", "Brief_Title" : "CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)", "Official_title" : "An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.", "Conditions" : ["Lymphocytic Leukemia, Chronic"], "Interventions" : ["Drug: chlorambucil", "Drug: obinutuzumab", "Drug: rituximab"], "Location_Countries" : ["Thailand", "Germany", "France", "Canada", "Croatia", "United Kingdom", "New Zealand", "Mexico", "Estonia", "Egypt", "Austria", "Bulgaria", "Hong Kong", "Russian Federation", "Australia", "Czechia", "Romania", "Switzerland", "Denmark", "Brazil", "Netherlands", "Slovakia", "Argentina", "Italy", "United States", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech. Detailed Description Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points. * BO21004 (Stage 1a) \[NCT01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported here. * BO21004 (Stage 1b) \[NCT01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately. * BO21004 (Stage 2) \[NCT02053610\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported separately. #Intervention - DRUG : obinutuzumab - 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles). - Other Names : - RO5072759, GA101, GAZYVA® - DRUG : rituximab - 375 mg/m\^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6. - Other Names : - Rituxan®, MabThera® - DRUG : chlorambucil - Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.

#Eligibility Criteria: Inclusion Criteria: * Adults >=18 years * Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL) * Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria * Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70 ml/min Exclusion Criteria: * Prior CLL therapy * Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation) * History of other malignancy unless the malignancy has been in remission without treatment for >=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone * Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing * Patients with active infection requiring systemic treatment Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01010061

{ "NCT_ID" : "NCT05070026", "Brief_Title" : "Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancersurgery on Perioperative Clinical Indexes、Inflammatory Reaction and Quality of Life Scores of Patients With Non-small Cell Lung Cancer", "Official_title" : "Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancer", "Conditions" : ["Video-assisted Thoracoscopic Surgery", "Inflammatory Reaction", "Life Scores"], "Interventions" : ["Other: uni-portal VATS group", "Other: three port VATS group"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Many recent studies have shown that surgical trauma will result in an immunosuppressive state. Combined with the effect of surgical stress, it will often lead to metabolic changes, systemic inflammatory response, and other problems. The body resists and removes the harmful factors through the inflammatory reaction. However, an excessive reaction will damage the normal tissues and cells of the body. The smooth recovery of the body needs to balance the degree of inflammatory reaction. Surgical patients will trigger different degrees of an inflammatory response due to different degrees of physical trauma, which runs through the process of postoperative recovery from the beginning of surgery and often prolongs the time of postoperative recovery. Reducing the intraoperative and postoperative inflammatory response of patients has always been the goal of surgeons, and a method is the reduction of surgical trauma. The successful experience of the first single-port thoracoscopic wedge resection of the lung in 2004 provided us with a new surgical idea. Subsequently, a large number of domestic and international studies and case reports show that single-port thoracoscopic surgery is safe and feasible in lobectomy and segmental resection. With the rapid development of single-port thoracoscopic surgery in recent years, the scope of application and clinical efficacy of the surgery are gradually becoming equivalent to the traditional three-port thoracoscopic surgery, which can ensure the safety of the operation and complete tumor resection, and has its own characteristics and advantages compared with the traditional three-port thoracoscopic surgery. The reduction of incisions can significantly improve the postoperative pain and recovery of patients and wound healing. In addition, single-port thoracoscopic surgery also has a subtle improvement in patients' intraoperative and postoperative inflammatory response compared with traditional three-port thoracoscopic surgery. In this study, we compared and analyzed the intraoperative and postoperative inflammatory factor levels of single-port thoracoscopic surgery and three-port thoracoscopic surgery in patients with non-small cell lung cancer (NSCLC). Through the comparison of the measured values, we further discussed the advantages of single-port thoracoscopic surgery in reducing inflammatory response and its application and promotion value in the treatment of patients with NSCLC compared with traditional three-port thoracoscopic surgery. #Intervention - OTHER : uni-portal VATS group - patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method - OTHER : three port VATS group - patients received pulmonary lobectomy under under general anesthesia by using three port VATS method

#Eligibility Criteria: Inclusion Criteria: * (1) NSCLC was diagnosed by imaging examination (chest enhanced computed tomography or positron emission tomography-computed tomography) and biopsy pathology; (2) TNM stage was stage I and II; (3) the patient had indications of radical operation; (4) the patient had good cardiopulmonary, liver, and kidney function and no obvious surgical contraindication before operation; (5) the preoperative inflammatory indexes of all patients were within the normal range Exclusion Criteria: * (1) the thoracoscopic operation was converted to thoractomy; (2) the operation time was more than 3 hours; (3) blood vessel rupture occurred during the operation, and the bleeding amount was more than 200 mL; (4) the patient had complications (the patient had fever exceeding 38.5 ℃, chest computed tomography confirmed intrapulmonary infection, incision infection, postoperative bleeding, requiring secondary thoracotomy, etc.). Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT05070026

{ "NCT_ID" : "NCT02341417", "Brief_Title" : "Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis", "Official_title" : "A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis", "Conditions" : ["Secondary Hyperparathyroidism, Chronic Kidney Disease"], "Interventions" : ["Drug: Cinacalcet"], "Location_Countries" : ["Greece", "Poland", "Russian Federation", "Belgium", "Ukraine", "Hungary", "Italy", "Germany", "United States", "France", "Czechia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis. Detailed Description This extension study was designed to characterize the long-term safety and tolerability of cinacalcet in pediatric patients from Amgen Studies 20130356 (NCT02138838) and 20110100 (NCT01439867) who either had completed the parent study or were ongoing at the time an administrative decision was made to end the parent study. After enrolling into this study participants were administered cinacalcet for 28 weeks or until the time of renal transplant or parathyroidectomy, whichever occurred first. The treatment period was followed by a 4-week safety follow-up period. #Intervention - DRUG : Cinacalcet - Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg. - Other Names : - Cinacalcet hydrochloride, Cinacalcet HCL, Sensipar®, Mimpara®

#Eligibility Criteria: INCLUSION CRITERIA: All subjects: * Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated. * Dialysate calcium concentration >= 2.5 mEq/L at day 1 All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159: * Subjects on anti-convulsant medication must be on a stable dose All subjects from 20130356: * Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination * Dry weight >= 12.5 kg at day 1 of Study 20140159 Subjects Randomized to the 20130356 Standard of Care Arm Only: * intact parathyroid hormone (iPTH) value >= 300 pg/mL (within 7 days of day 1 in Study 20140159) * Corrected calcium value >= 8.8 mg/dL within 7 days of day 1 in Study 20140159 All Subjects from 20110100: * Completed week 26 End of Study visit in the, 20110100 study or on study at the time of Study 20110100 termination * Dry weight >= 7 kg at day 1 of Study 20140159 EXCLUSION CRITERIA: General (studies 20130356 and 20110100): * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s), other than Amgen Studies 20130356 or 20110100. * Other investigational procedures while participating in this study are excluded. * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. * Subject has known sensitivity to any of the products to be administered during dosing. * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary [ediary]) to the best of the subject and investigator's knowledge * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. * Subject previously has entered this study. * If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment. * Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment * History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval * A new onset of seizures or worsening of pre-existing seizure disorder All Subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and the screening visit in Study 20140159 will have the following exclusion criteria applied during screening and day 1: * Unstable chronic heart failure defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening * Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159 * Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely * Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening * Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase [AST] >= 1.5 × upper limit of normal [ULN] OR alanine aminotransferase [ALT] >= 1.5 × ULN OR total bilirubin >= 1 × ULN per institutional laboratory range) during screening All Subjects - Day 1 Study Visit: * Subject has an ongoing adverse event from Studies 20130356 or 20110100 that is considered related to investigational product and is >= Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0) grade 3, and/or considered clinically significant in the opinion of the investigator * Central laboratory values were not obtained/are not available at day 1 in Study 20140159 * Corrected QT Interval (QTc) > 500 ms, using Bazett's formula * QTc >= 450 to <= 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist * Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine) * Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol) Sex : ALL Ages : - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT02341417

{ "NCT_ID" : "NCT01579721", "Brief_Title" : "Prospective Randomized Study of SILS Versus CLS for Rectal Cancer", "Official_title" : "Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer", "Conditions" : ["Rectal Cancer", "Adenocarcinoma"], "Interventions" : ["Procedure: Single Incision Laparoscopic Surgery"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery. Design: randomized, prospective clinical study Patients: 40 patients #Intervention - PROCEDURE : Single Incision Laparoscopic Surgery - Single incision laparoscopic surgery for rectal cancer

#Eligibility Criteria: Inclusion Criteria: * Patients > 18 years. * ASA I-III. * Tumor-location: maximum 15 cm from the anal verge. * No involvement of neighbouring organs. * No distant metastasis. Exclusion Criteria: * Linguistic, physical or psychological barriers precluding oral and written consent. * History of intestinal surgery (excl. appendectomy). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01579721

{ "NCT_ID" : "NCT00109967", "Brief_Title" : "CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma", "Official_title" : "A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma", "Conditions" : ["Recurrent Mantle Cell Lymphoma"], "Interventions" : ["Drug: temsirolimus", "Biological: rituximab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells Detailed Description PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab. II. Determine the tolerability of this regimen in these patients by assessing toxicity. SECONDARY OBJECTIVES: I. Determine the time to disease progression and overall survival of patients treated with this regimen. II. Determine the duration of response in patients treated with this regimen. OUTLINE: Patients are stratified according to prior response to rituximab (sensitive \[partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last treatment with rituximab alone or in combination with chemotherapy\] vs refractory \[stable or progressive disease OR a PR or CR that lasted \< 6 months after the last treatment with rituximab alone or in combination with chemotherapy\]). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years. #Intervention - BIOLOGICAL : rituximab - 375 mg/m\^2 Given IV - Other Names : - IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan - DRUG : temsirolimus - 25 mg given IV - Other Names : - CCI-779, cell cycle inhibitor 779, Torisel

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed* mantle cell lymphoma (MCL) * Relapsed, refractory, or stable disease after prior treatment * Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics * Measurable disease, defined as >= 1 of the following: * Unidimensionally measurable lymph node or tumor mass >= 2 cm by CT scan or MRI * Splenic enlargement if spleen is palpable >= 3 cm below the left costal margin * Malignant lymphocytosis if absolute lymphocytic count >= 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry * No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement) * Performance status - Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 2 * At least 3 months * No other concurrent treatment for MCL * Absolute neutrophil count >= 1,000/mm^3 * Platelet count >= 75,000/mm^3 * Total bilirubin <= 1.5 times upper limit of normal (ULN) * Direct bilirubin < 1.5 times ULN * Aspartate aminotransferase (AST) <= 3 times ULN (5 times ULN if liver involvement by MCL is present) * Creatinine <= 2 times ULN * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * Cholesterol <= 350 mg/dL * Fasting triglycerides < 400 mg/dL * No known HIV positivity * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs * Prior biologic response modifiers allowed * Prior immunotherapy allowed * Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed * No concurrent prophylactic growth factor to support neutrophils * Prior chemotherapy allowed * No other concurrent chemotherapy * No concurrent corticosteroids to induce an antitumor response * Concurrent corticosteroids (<= 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed * Prior radiotherapy allowed * No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor * No other concurrent investigational or commercial agents or therapies for MCL * No other concurrent immunosuppressive therapy Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00109967

{ "NCT_ID" : "NCT04542356", "Brief_Title" : "Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer", "Official_title" : "Efficacy and Safety of PEGylated Recombinant Human Granulocyte Stimulating Factor in the Prevention of Neutropenia During Concurrent Chemoradiotherapy for Cervical Cancer", "Conditions" : ["Cervical Cancer"], "Interventions" : ["Drug: rhG-CSF", "Drug: PEG-rhG-CSF"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer. Detailed Description Study design: In this prospective, single-center, randomized controlled study, patients with locally advanced cervical cancer are randomly divided into two groups. Patients in the experimental group will receive PEG-rhG-CSF 6mg prevention during concurrent chemoradiotherapy, whereas the control group do not use PEG-rhG-CSF for prevention. When the patient's ANC is less than 1✕109/L, 5μg/kg rhG-CSF will be given for treatment until the ANC returned to 2✕109/L. Case selection: patients with IIb-IIIb cervical cancer, squamous cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and carboplatin with Concurrent Radiotherapy. Primary end point: incidence and duration of grade 3/4 neutropenia in patients. Secondary endpoints: 1) Incidence of febrile neutropenia (FN); 2) the rate of postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of chemotherapy; 3) Changes of bone marrow function in patients 3 months and 6 months after radiotherapy. Safety assessment: laboratory safety testing, including platelet count and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, bone pain, etc. #Intervention - DRUG : PEG-rhG-CSF - During the concurrent chemoradiotherapy, a single subcutaneous injection of 6 mg PEG-rhG-CSF was given to the patient 2 hours after radiotherapy on the first day after the end of chemotherapy. Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly. - DRUG : rhG-CSF - Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.

#Eligibility Criteria: Inclusion Criteria: * 18 <= age <= 70 years; * Patients with cervical cancer who have not undergone surgery for initial treatment, the international union of gynecology and obstetrics (FIGO) stage IIb-IIIb; Squamous cell carcinoma diagnosed by histopathology. * The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score<=1; * Bone marrow hematopoietic function is normal before treatment (ANC>=1.8×109/L, PLT>=100×109/L, Hb>=90g/L, WBC>=4.0×109/L); * No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction; * All patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment, and women of childbearing age must have a negative urine pregnancy test prior to treatment administration; * The subjects voluntarily participate in this clinical trial and sign an informed consent form. Exclusion Criteria: * Those who refuse to accept PEG-rh-G-CSF; * Currently conducting clinical trials of other drugs; * Uncontrolled infection before treatment, body temperature >= 38℃; * Chronic diseases of the heart, kidney, liver or other important organs; * Patients with severe uncontrolled diabetes; * Pregnant or lactating female patients; * Persons with allergic diseases or allergic constitution, or allergic to this product or other biological products derived from genetically engineered E. coli; * Suspected or confirmed drug, substance or alcohol abuse; * Severe mental or neurological disorders that affect informed consent and/or adverse reaction presentation or observation; * HIV-positive people; * Patients requiring radiation therapy for the retroperitoneal or inguinal region. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04542356

{ "NCT_ID" : "NCT00860457", "Brief_Title" : "Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)", "Official_title" : "Lenalidomide Following Rituximab and Fludarabine in Untreated Chronic Lymphocytic Leukemia", "Conditions" : ["Chronic Lymphocytic Leukemia"], "Interventions" : ["Drug: Fludarabine", "Drug: Rituximab", "Drug: Lenalidomide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received any treatment for their disease. Current therapy for this disease includes the use of combination chemotherapy regimens containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this research because we are attempting to improve the response, or outcome, of Fludarabine and Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. This research is being done because we are attempting to find a better treatment for chronic lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of Fludarabine and Rituximab. The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and Rituximab alone. Detailed Description This is a single institution Phase II study where all enrolled patients with untreated CLL will receive fludarabine and rituximab (FR) combination therapy. Subjects who demonstrate Stable disease or Progressive disease after completing 3 cycles of FR will receive lenalidomide monotherapy for a maximum of 6 cycles. Subjects who achieve \>/= PR after receiving 3 cycles of FR will receive 3 additional cycles of FR (maximum of 6 cycles). Upon completion of FR treatment subjects will receive lenalidomide monotherapy for a maximum of 6 cycles. Response assessment will be performed for Module A (FR): after every cycle, but would include imaging after cycle 3 if clinically indicated. Response assessment will be performed for Module B (Lenalidomide monotherapy): Before starting Lenalidomide therapy, after every cycle and on completion of therapy. Imaging for Module B would be obtained before starting lenalidomide therapy, and on completion of therapy. Bone marrow biopsies will be performed prior to starting therapy in Module A (FR), prior to starting Module B (Lenalidomide), and on completion of Module B. Bone marrow biopsies can be obtained once during Lenalidomide therapy at the discretion of the investigator. Minimum residual disease assessment of bone marrow specimens should include immunohistochemistries and flow cytometry. Additional studies on bone marrow specimens will be sent for flow cytometric analysis (standard or four color flow), ZAP-70 immunohistochemical stains and FISH analysis (13q deletion, trisomy 12, 11q deletion, and 17p) will be performed at the time intervals described above. Response will be assessed according to the Cheson Criteria. Blood specimens for optional correlative studies will be drawn on Day 0 prior to FR, prior to starting lenalidomide, 90 days after initiation of lenalidomide, and 7 days after the last dose of lenalidomide. #Intervention - DRUG : Rituximab - 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles - Other Names : - Rituxan - DRUG : Fludarabine - 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles - Other Names : - Fludara - DRUG : Lenalidomide - 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles - Other Names : - Revlimid

#Eligibility Criteria: Inclusion Criteria: * Understand and voluntarily sign informed consent form * No prior therapy for CLL * Able to adhere to study visit schedule and other protocol requirements * CLL with any Rai Stage requiring therapy * ECOG performance status <= 2 * Absolute neutrophil count >= 1.0 * Platelet count >= 75 * Serum creatinine <= 1.5 * Total bilirubin <= 1.5 * AST and ALT <= 2 x ULN * Females of childbearing potential must have negative pregnancy test * Disease free of prior malignancies for >= 5 years * Able to take aspirin daily as prophylactic anticoagulation Exclusion Criteria: * Any serious medical condition, lab abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Pregnant or lactating females * Any condition, including the presence of lab abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study * Use of any other experimental drug or therapy within 28 days of baseline * Concurrent use of other anti-cancer agents or treatments * Known positive for HIV or infectious active hepatitis, type A, B * Known hypersensitivity to nucleoside analogue or rituximab * Previous treatment for CLL prior to enrolling in study * Known hypersensitivity to thalidomide * The development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs * Any prior use of lenalidomide * Active hemolysis Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00860457

{ "NCT_ID" : "NCT01308775", "Brief_Title" : "Comparing (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer", "Official_title" : "A Pilot Study Comparing a Patient-Centered Symptom Reporting Follow Up Program (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Behavioral: SIS.NET, Routine Follow-up"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a pilot study that will compare two systems of breast cancer follow up care and will evaluate a number of parameters indicating quality and efficiency of care delivery as well as patient satisfaction with care. Approximately 100 breast cancer patients who have completed the acute phase of treatment will be randomized to one of two follow up care plans. Detailed Description Over 200,000 women were diagnosed with breast cancer in the year 2006. Many of these women will be rendered free of cancer, but will need ongoing disease specific care and surveillance. The estimated number of breast cancer survivors in the year 2003 was 2.3 million (1). With outcomes improving after the diagnosis of early breast cancer, the number of breast cancer survivors in follow up care will continue to increase and eventually result in an unmanageable load on the subspecialties of medical and surgical oncology. Most of these patients continue to be seen by an oncology specialist for at least five years after their cancer diagnosis, but this type of follow up may not be necessary or optimally utilized. Alternate Strategies for Health Care Delivery Studies suggest that oncology follow up care is costly to the health care system no matter who the provider is, and in some cases, diagnostic tests are overused (2). In a randomized trial of 296 women with a history of breast cancer in Great Britain, transfer of routine follow-up care to a family physician did not result in an increase in the time to diagnosis of recurrence (3). Patient satisfaction was greater and health service costs were less, and anxiety and health related quality of life were unaffected (4, 5). A similar multicenter trial of 968 early-stage breast cancer patients in Canada who had completed adjuvant treatment randomized patients to follow up in a cancer center or with their own family physician (6). This study found no statistically significant differences in number of recurrences, deaths, recurrence related serious clinical events, or patient reported health-related quality of life questionnaires between the groups. While transferring oncology follow-up care back to primary care physicians seems a reasonable alternative, the shortage of primary care physicians in certain regions of the US and around the world, limits this approach (7, 8). A study in Sweden compared nurse-led follow-up vs. physician follow-up in 264 consecutively selected women with newly diagnosed Stage I or II breast cancer (9). Outcomes included measures of patient well-being, satisfaction, access to medical care, and medical safety. Questionnaires containing the Hospital Anxiety and Depression Scale (HADS), and the Satisfaction and Accessibility (SaaC) scale were obtained at baseline and twice a year over a period of 5 years. Number of contacts with health care services, number of diagnostic procedures, and time to recurrence or death were monitored. Ratings of HADS and SaaC scales did not show any statistically significant differences between the follow-up groups. The levels of anxiety and depression were generally low, and levels of patient satisfaction high. There were no differences between the groups concerning time to recurrence or death suggesting that follow-up care with an experienced nurse professional is safe and effective. Various strategies have been studied to evaluate alternatives to routine clinic visits and referrals to subspecialists in order to improve access to care and to lower health care costs. One such study tested the hypotheses that virtual outreach would reduce number of contacts with the health care system, reduce the number of medical tests and interventions, and have a positive impact on patient satisfaction. A randomized controlled trial was conducted which compared standard outpatient referral to joint teleconsultations between general practitioners (GP), specialists, and patients (10). Patients randomized to virtual outreach underwent a joint teleconsultation, in which they and their GP consulted with a hospital specialist via a videolink. In this study, patients in the virtual outreach group were more likely to be scheduled for a follow-up appointment, but fewer tests and investigations were ordered. In the 6-month period following the initial consultation, there were no significant differences in number of contacts or outpatient visits with GP, inpatient stays, procedures, or prescriptions between the randomized groups. Patient satisfaction was greater after a virtual outreach consultation, and patient enablement and the physical and psychological scores of the Short Form-12, did not differ between the randomized groups. Interestingly, health care costs over 6 months were greater for the virtual outreach consultations than for conventional outpatients, but overall cost, time, and productivity savings to patients were identified. This study represents an example of how technology can be utilized to streamline care and provide more patient centered services, but that these services may not save money overall in the health care system. The need to assess the cost-effectiveness and patient outcomes of alternate surveillance and follow up strategies was recently highlighted in a review article by Tolaney (11). UCSF and Dynamic Clinical Systems (DCS) Collaboration The UCSF Breast Care Center has embarked upon collaboration with Dynamic Clinic Systems to implement a computer based, patient centered system of symptom reporting and data collection to improve clinical care to our patients and generate databases of patient reported symptoms and outcomes information for research purposes. Dynamic Clinical Systems (DCS) is a provider of real-time Web-based applications focusing on the patient-clinician interaction. The DCS approach enables patients to provide health data electronically. Clinicians may use this data for research, medical documentation, and registries depending on the type of data collected and the consent of the patient. Through this system, patients will report their own health information via the DCS web-based Integrated Survey System (ISS). The process is as follows: A real-time interface downloads appointments from the hospital scheduling system into ISS. Survey groups are automatically scheduled based on pre-defined timing parameters. Prior to sending the patient their first survey, each patient will be called and welcomed to the program and asked if they use the internet. If they do, they will be given instructions for completion of surveys at home. If they need assistance, they will be given an appointment to come to our resource center and work with our staff member to complete the survey. The patient will be notified (via automatically-generated email from ISS or hospital letter/phone) to either sign on and take the survey from home or come to clinic early to take the survey. Once logged in, the patient has the opportunity to indicate online consent (to be approved by CHR) to share data for research purposes. An analyst will monitor the progress of survey completion and will call any patient whose surveys are not complete prior to their clinic appointment to facilitate survey completion. At the end of the process, a patient summary report is generated in ISS displaying a summary of patient survey answers, longitudinal comparisons of previous surveys, red flags and warnings, and quality measures. The clinician uses this report during the clinic visit to focus the discussion on highlighted items. DCS is a service vendor who has built and who services the online-questionnaire platform. All content in the questionnaires has been created and reviewed by the investigators at UCSF (with the exception of standardized surveys such as the SF-36 and other validated questionnaires). Other than this, the DCS has no role in this study, and it does not receive or have access to information regarding study outcomes (such as in terms of patient visits or interventions) from either arm of the study. We plan to implement and evaluate a comprehensive survivorship program, supported by this interactive web-based system for reporting physical and psychological symptoms. The system will capture structured data that then can be used to drive translation of research findings to improve care for survivors. The System for Individualized survivorship care, based on patient Self-reported data, with review by Nurse practitioners, targeted Education, and Triage to appropriate services to improve symptom management and outcomes will be called SIS.NET #Intervention - BEHAVIORAL : SIS.NET, Routine Follow-up - * SIS.NET - One or two oncology related clinic visits per year (as recommended by the American Society of Clinical Oncology breast cancer follow up guidelines (18)), with additional access to oncology care driven by ongoing review of patient's self reported symptoms through web-based questionnaires. * Routine follow up care with appointment frequency determined by the treating medical oncologist or oncology/breast surgeon. Patients complete the same web-based symptom questionnaires within 30 days of a scheduled clinic visit but the results are not reviewed until their clinic visit.

#Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with Stage I to Stage III breast cancer that have completed their acute phase of treatment. (This includes surgery, radiation, chemotherapy, or any experimental therapies offered in a clinical trial as adjuvant treatment.) * Patients who received chemotherapy must be 6 months out from completion of chemotherapy. * For patients who receive adjuvant hormonal therapy (with or without prior chemotherapy), patients must be 3 months out from initiation of hormonal therapy. * For patients who do not receive adjuvant chemotherapy or hormonal therapy, patients must be 3 months out from surgery and radiation therapy. * Patients must have recovered from all serious side effects of acute phase of treatment for breast cancer. * Patients must be willing to complete symptom reporting questionnaires at the intervals assigned by their care group. * Patients must have hematologic, cardiac, hepatic, and renal function that are back to their pre-treatment values. * Patient must be able to read and speak English sufficiently to complete symptom reporting questionnaires and discuss details of symptoms and health status over the telephone. * Patient must have access to a computer on which to complete the on-line surveys or must be willing to come to the UCSF Cancer Resource Center to complete questionnaires at the intervals assigned by their care group. Exclusion Criteria: * History of severe depression or an anxiety disorder that is felt to interfere with a patient's ability to accurately self-report symptoms. * Complications from breast surgery or reconstruction, or from chemotherapy or radiation that may require regular ongoing clinic visits for physical and/or laboratory evaluation. - Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01308775