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Study Objectives
This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses.
Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days.
Conditions: Breast Cancer, Cancer, Carcinoma, Renal Cell, Lymphoma, Ovarian Cancer
Intervention / Treatment:
DRUG: PSC 833, DRUG: paclitaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | Biopsy proven advanced cancer, for whom no better therapy exists.
Enrollment of patients with breast cancer, lymphoma, renal cell cancer or ovarian cancer are encouraged.
Patients with a life expectancy of at least 16 weeks, and a performance status (Karnofsky Scale) of 70% or greater. No rapidly growing disease.
Patients with prior therapy.
WBC greater than 3,000/mm(3) and AGC greater than 1000/mm(3); platelets greater than 100,000/mm(3).
Creatinine clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; SGOT less than 90 u/L; SGPT less than 100 u/L.
Patients must sign an informed consent and have geographic accessibility to return for follow up and treatment.
No history of brain metastases.
No patients currently receiving treatment with the following agents or any other agent known to significantly interact with cyclosporine, and the treatment cannot be discontinued , or changed to another therapeutically equivalent allowable drug: acetazolamide, barbiturates, corticosteroids, diltiazem, erythromycin, fluconazole, ketoconazole, nicardipine, phenothiazines, phenytoin, rifampin, sulfonamides, trimethoprim, verapamil, tamoxifen, progesterone, quinine, quinidine, or amiodarone.
No patients with a history of coronary artery disease with angina pectoris or history of congestive heart failure.
No patients with a history of cardiac disease, other than angina pectoris or congestive heart failure, including patients with arrhythmias or conduction system abnormalities will be considered on an individual basis.
No patients with symptomatic peripheral neuropathy (grade 2 or greater).
No patients with a positive serology for HIV.
No patients who are pregnant or unwilling to practice adequate contraception.
No patients with prior bone marrow transplantation or extensive irradiation resulting in compromised bone marrow reserve. | 40,972 |
Study Objectives
The purpose of this study is to investigate the effect of stroke volume variation (SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.
Conditions: Bladder Cancer
Intervention / Treatment:
OTHER: crystalloid, OTHER: colloid, OTHER: mannitol, OTHER: lasix
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Bladder cancer patients who received radical cystectomy
* Patients with American Society of Anesthesiologists physical status scale classification 1, 2
* Patients who agree with written informed consent
Exclusion Criteria:
* Patients with history of arrhythmia, heart failure patients
* Patients with history of renal failure patients
* Patients with history of abdominal surgery
* Patients who received emergency operation
* Patients who do not agree with study | 9,351 |
Study Objectives
Many of the patients operated with sphincter preservation will present an alteration of bowel function and defecation. This dysfunction is variable in its symptoms and severity, and manifests itself in the form of urgency, incontinence and fragmentation of faeces, with repeated, incomplete or difficult evacuations. The set of these symptoms constitutes what is known as anterior resection syndrome (ARS), which can negatively influence the quality of life of the operated patients and constitutes the main objective of the study to be investigated.
From this study, the investigators want to evaluate the efficacy of stimulation of the efferent loop prior to the closure of the ileostomy along with rehabilitation of the pelvic floor after the closure of the ileostomy, in the quality of life of patients who underwent anterior resection of the rectum. A non-pharmacological randomized clinical trial will be conducted, comparing a control group (usual clinical practice), with respect to the experimental group where stimulation of the efferent loop will be performed prior to the closure of the ostomy along with pelvic floor rehabilitation after the closure of the latter. The main dependent variable will be the quality of life evaluated according to the QLQ CR-29 questionnaire, and secondary dependent variables will be evaluated postoperative paralytic ileus and the previous resection syndrome using the LARS scale.
Conditions: Rectal Cancer
Intervention / Treatment:
PROCEDURE: Stimulation of efferent loop, PROCEDURE: Rehabilitation pelvic floor
Location: Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Patients undergoing scheduled rectal cancer surgery, carriers of a protective ileostomy with a scheduled surgery date for ileostomy closure
* Patients over 18 years of age
* Patients with absence of cognitive deficit (Pfeiffer: 0-2 errors)
* Patients who agree to participate in the study and sign the informed consent
Exclusion Criteria:
* End ileostomy patients
* Patients with active treatment of Qt or Rt
* Patients with some stoma complication such as mucosal prolapse or peristomal hernia
* Patients with fecal incontinence prior to anterior rectal resection surgery (Wexner scale: greater than 3 points)
* Patients who do not agree to participate in the study
* Patients with cognitive deficit | 22,254 |
Study Objectives
The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: XRP9881
Location: Argentina, Korea, Republic of, Netherlands, Belgium, Turkey, Germany, United States, South Africa, Canada, Spain, France, Switzerland, Denmark, Colombia, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
In order to be eligible for this trial you must:
* Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.
* Have received previous treatment with anthracyclines (e.g. doxorubicin \[Adriamycin or Doxil\] or epirubicin \[Ellence\]), taxanes (paclitaxel \[Taxol or Abraxane\] or docetaxel \[Taxotere\]) and capecitabine (e.g. Xeloda) for your breast cancer and your doctor has determined that these treatments are no longer of benefit to you.
* Be at least 18 years of age
* Not be taking other treatments for your cancer at the time you enter the trial.
* Not be pregnant
* Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (lab tests, CT scans).
Exclusion Criteria:
* None listed here. Can be discussed with your doctor. | 28,147 |
Study Objectives
This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue sarcoma.
Conditions: Pleomorphic Rhabdomyosarcoma, Stage IIB Adult Soft Tissue Sarcoma AJCC v7, Stage III Adult Soft Tissue Sarcoma AJCC v7, Stage IV Adult Soft Tissue Sarcoma AJCC v7
Intervention / Treatment:
DRUG: Epirubicin Hydrochloride, RADIATION: External Beam Radiation Therapy, DRUG: Ifosfamide, OTHER: Laboratory Biomarker Analysis, DRUG: Sorafenib Tosylate, PROCEDURE: Therapeutic Conventional Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically confirmed, soft-tissue sarcoma: excluding rhabdomyosarcoma (pleomorphic rhabdomyosarcoma patients are eligible), Ewing's, primitive neuroectodermal tumor (PNET), osteosarcoma, or gastrointestinal stromal tumor
* American Joint Committee on Cancer (AJCC) (7th edition) stage IIb, III, or IV patients planned for resection of the primary tumor
* \> 5 cm in greatest dimension
* Intermediate or high-grade
* Superficial or deep
* Sarcoma located on upper (includes shoulder) or lower (includes hip) extremities or on body wall
* Intermediate or high-grade: grades 2 or 3 on scale of 1-3
* Left ventricular ejection fraction (LVEF) \>= 50%
* Absolute neutrophil count (ANC) \>= 1500/uL
* Hemoglobin (Hgb) \>= 9.0 g/dL
* Platelets \>= 100,000/uL
* Creatinine =\< 1.5 x upper limit of normal (ULN)
* Bilirubin =\< 1.5 mg/dL
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 1.5 x ULN
* International normalized ratio (INR) \< 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable
* No prior chemotherapy, radiation, or biotherapy
* No major surgery within 4 weeks prior to study entry
* No contraindications to limb-sparing surgery; patient should be evaluated by a surgeon who specializes in sarcoma resections prior to study enrollment to ensure patient (pt) is a candidate for limb-sparing surgery
* No severe peripheral vascular disease
* Adequate contraception must be used and patients must not be pregnant or breastfeeding; women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men and women should use adequate birth control for at least thirty days after the last administration of sorafenib
* Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Patient must sign a study-specific consent form prior to registration
* Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria:
* Patients with known brain metastases; patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastases
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2, symptomatic congestive heart failure, unstable angina pectoris, cardiac ventricular arrhythmia requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements; patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
* Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
* Pulmonary hemorrhage/bleeding event \>= CTCAE grade 2 within 4 weeks of first dose of study drug
* Any other hemorrhage/bleeding event \>= CTCAE grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
* Evidence or history of bleeding diathesis or coagulopathy
* Major surgery or significant traumatic injury within 4 weeks of first study drug
* Use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
* Known or suspected allergy to sorafenib or any agent given in the course of this trial
* Any condition that impairs patient's ability to swallow whole pills
* Any malabsorption problem
* Pregnant or lactating women are excluded from this study
* Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse
* Any uncontrolled thyroid disease
* Requirement for hemodialysis or peritoneal dialysis | 29,745 |
Study Objectives
The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS).
The goal is to obtain a 15% increase of EFS at 2 years.
Conditions: B-Cell Lymphoma
Intervention / Treatment:
DRUG: Zevalin plus BEAM
Location: France, Switzerland, Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Aged 18 to 65 years
* Patients with pathologically proven at relapse, low grade B-cell lymphoma CD20- positive (World Health Organization \[WHO\] classification):
* Marginal zone;
* Lymphocytic; or
* Follicular.
* In relapse after complete remission (CR), less than partial remission (PR) or partial response (maximum of 3 lines of treatment)
* Previously treated with chemotherapy regimen with or without rituximab
* With a chemo-sensitive disease using salvage therapy
* Eligible for autologous stem cell transplantation
* ECOG performance status 0 to 2
* Minimum life expectancy of 3 months
* Negative HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies \< 4 weeks (except after vaccination)
* Signed informed consent form
Exclusion Criteria:
* Histological transformation in diffuse large cell from a low grade B-cell lymphoma
* Prior transplantation
* Contraindication to any drug contained in the chemotherapy regimens
* Large bone marrow irradiation \> 40%
* Bone marrow infiltration \> 25%
* Lack of sufficient autologous stem cells for transplantation
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
* Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigational Drug Brochure \[IDB\])
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l, unless related to bone marrow infiltration
* Poor renal function (creatinine level \> 2.5 maximum normal level) unless abnormalities are related to the lymphoma
* Poor hepatic function (total bilirubin level \> 30 mmol/l, transaminases \> 2.5 maximum normal level) unless abnormalities are related to the lymphoma
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
* Presence of anti-murine antibody (HAMA) reactivity
* Known hypersensitivity to murine antibodies or proteins
* Pregnant women
* Adult patients unable to give informed consent because of intellectual impairment | 26,064 |
Study Objectives
Background:
-Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in one of their proteins called succinate dehydrogenase (SDH). Vandetanib is a cancer drug that has been approved to treat thyroid cancer and has been used with some success in other tumors that have a similar loss of SDH. Researchers want to see if this drug can also decrease tumor growth in people with WT-GIST.
Objectives:
-To test whether the study drug will benefit people with WT-GIST.
Eligibility:
-Adults and children 3 years old and older with WT-GIST.
Design:
* Researchers will test participants tumor tissue to confirm it is the wild type of GIST.
* Participants will be screened with a medical history, physical exam, and blood tests. They will also have electrical recording of the heart (Eastern Cooperative Oncology Group (ECOG)) and scans of the tumor.
* Participants will take the study drug in 28-day cycles. Their doctor will decide how many cycles they can complete.
* They will take the study drug once every day and record it in a diary.
* On Day 14, they will also visit their doctor to look for side effects.
* Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood pressure check, and blood tests. These tests will then be done periodically for as long as they are in the study.
* Before cycle 4, scans will be done to check the size of the cancer. Most of these will be repeated every 3-6 cycles.
* When they stop taking the study drug, participants will return to the clinic for a physical exam and blood tests.
Conditions: GIST
Intervention / Treatment:
DRUG: Vandetanib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | -INCLUSION CRITERIA
Age:
-greater than or equal to 3 years of age and Body Surface Area (BSA) greater than or equal to 0.5 m(2)
Diagnosis
* Histologically or cytologically confirmed Gastrointestinal Stromal Tumors (GIST) by the Laboratory of Pathology, National Cancer Institute (NCI).
* Absence of Kit and platelet derived growth factor receptor alpha (PDGFRA) mutation confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
* Participants must have measurable disease as defined in Response Evaluation Criteria in Solid Tumors (RECIST (v1.1) as the presence of at least one lesion not previously irradiated, that can be accurately measured at baseline greater than or equal to 10mm in the longest diameter (except lymph nodes which must have short axis greater than or equal to 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
Prior therapy:
There are no standard chemotherapy regimens known to be effective for wt-GIST. Therefore, previously untreated participants are eligible if their tumor(s) are measurable.
* Participants must be at least 4 weeks from prior surgical procedures and surgical incisions must be healed.
* Participants must have had their last fraction of external beam radiation therapy at least 4 weeks prior to enrollment.
* Participants must have had their last dose of cytotoxic chemotherapy at least 28 days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollment.
* Participants must have received their last dose of short acting colony stimulating factor, such as filgrastim or sargramostim at least 72 hours prior to enrollment and their last dose of long-acting colony stimulating factors, such as PEG-filgrastim at least 7 days prior to enrollment.
* Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria in Adverse Events (CTCAE v.4.0)) level prior to enrollment (does not apply to alopecia).
Performance Status: Lansky (for participants 10 years of age or younger) or Karnofsky (for participants older than 10 years) performance score greater than 50
Patients must have normal organ and marrow function as defined below:
* Hematological Function: The peripheral absolute neutrophil count must be at least 1,500/microL and the platelet count must be at least 100,000/microL within 72 hours prior to enrollment.
* Coagulation: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) must not be more than 1.5 x upper limit of normal (ULN) within 72 hours prior to enrollment. PT and PTT should drawn by venipuncture, rather than from a central venous catheter when feasible.
* Hepatic Function: Bilirubin must not be more than 1.5 x ULN (does not apply to patients with Gilberts Disease) and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must not be more than 2.5 x ULN within 72 hours prior to enrollment, or greater than 5.0 X ULN if in the Investigator s judgment it is related to liver metastases. AST and ALT may be up to 5 x ULN within 72 hours prior to enrollment in participants with hepatic metastases.
* Renal Function: Participants must have an age-adjusted normal serum creatinine (see Table) or a creatinine clearance of at least 50 ml/min/1.73 m(2).
Age (years) Male Female
3 to 5 = .42
5 to \<10 = 1
10 to \<13 = 1.2
13 to \<16 = 1.5 male and 1.4 female
16 and older = 1.7 male and 1.4 female
Hypertension:
-Participants should have normal blood pressure according to age. Participants 18 years of age and younger should have a blood pressure 95th percentile for age, height and gender, and should not be receiving medication for treatment of hypertension. Preexisting hypertension in adults should be controlled (either with pharmacological or non-pharmacological methods) at the time of enrollment.
Birth Control:
* Participants of child-bearing or child-fathering potential must be willing to use a medically effective form of birth control, which includes abstinence, while taking vandetanib and for 4 months after the last dose. \[Female patients must be 1 year postmenopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign the informed consent form \[ICF\]) and for 3 months after the last dose of vandetanib to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
* Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign the ICF) and for 4 months after the last dose of vandetanib to prevent pregnancy in a partner.\]
* Negative pregnancy test for women of childbearing potential.
Informed Consent:
-Participants who are greater than or equal to 18 years of age or Legally Authorized Representative (LAR) of participants who are younger than 18 years must sign an informed consent for the Pediatric Oncology Branch (POB) Screening Protocol (01-C-0157: Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) Clinical Research Protocols) prior to participating in studies required to determine eligibility for this trial. After confirmation of eligibility, participants who are greater than or equal to 18 years of age or LAR of minor participants must sign an informed consent document for this trial, indicating that they are aware of the investigational nature of the proposed treatment, the risks and benefits of participating and the alternatives to participating, prior to the conduct of any study procedures.
EXCLUSION CRITERIA
Presence of any of the following will prevent a subject from participation:
* Pregnant or breast feeding females because vandetanib may be harmful to the developing fetus or nursing infant and has been found to be embryotoxic, fetotoxic and teratogenic in rats.
* Subjects who are receiving any other investigational agents or who have received an investigational agent within 28 days prior to enrollment (does not apply to participation in survival follow up), or who have previous exposure to vandetanib.
* Abnormal Electrolyte Levels: Participants with a serum potassium less than 3.5 mmol/L or a serum ionized calcium or magnesium below the lower limits of normal (or above Common Terminology Criteria in Adverse Events (CTCAE) Grade 1 upper limit). Correction of these electrolyte abnormalities with supplements is allowed. (Serum calcium above the CTCAE Grade 1 upper limit. In cases where the serum calcium is below the normal range, the calcium adjusted for albumin is to be obtained and substituted for the measured serum value. Exclusion is to then be based on the calcium adjusted for albumin values falling below the normal limit: Corrected Calcium = Ca + 0.8 x (4-serum albumin).)
* Presence of hypertension: Diastolic blood pressure above the 95% for age in children (Appendix 2) and \> 160 mmHg systolic or \>100 mmHg diastolic in adults on at least 2 of 3 measurements with an appropriate-size cuff who are unable to achieve blood pressure control with optimal anti-hypertensive therapy. Patients who are treated with antihypertensive medications with good response are eligible.
History of Cardiac Disorder:
* Participants with a history of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation, left bundle branch block) that is symptomatic or requires treatment (except for controlled atrial fibrillation).
* History of any significant cardiac event (e.g. myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease greater than or equal 2 within 12 weeks before starting treatment, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
* Participants with a history of congenitally prolonged corrected QT interval (QTc), a first degree relative with unexplained sudden death under 40 years of age, or a measured QTcB (Bazetts correction) longer than 480 msec on electrocardiography (ECG). ECGs should be performed after correction of electrolyte abnormalities. Participants with a prolonged QTcB should have a repeat ECG twice, at least 24 hour apart, and the average of the 3 QTcBs should not exceed 480 msec. History of QT prolongation associated with other medications that required discontinuation of that medication.
* Participants receiving a medication that has a known risk of QTc prolongation or is associated with Torsades de Pointes or any prohibited medications, concomitantly or within 14 days (28 days for levomethadyl) of enrollment.
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of vandetanib as evidenced by uncontrolled nausea, vomiting or diarrhea and/or current need for parenteral support with iron or Vitamin B.
* Other clinically severe or uncontrolled systemic illness or any concurrent condition that in the view of the principal investigator could compromise the participant's ability to tolerate vandetanib or could compromise study procedures or endpoints, including interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.
* Unstable brain metastases or spinal cord compression that requires treatment, unless the treatment ended at least 4 weeks before starting treatment and the condition has been stable without steroid treatment for at least 10 days.
* Major surgery (includes surgery that carries significant risk of blood loss, extended periods of general anesthesia, or requires at least an overnight hospital admission) within 28 days before starting treatment.
* Involvement in the planning and/or conduct of the study.
* Previous enrollment in the present study.
* Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skin. | 827 |
Study Objectives
This study will explore beliefs and knowledge about genetics and smoking among smokers who have a first or second degree relative with advanced lung cancer, and whether their understanding of genetic risk influences their desire to quit smoking.
Healthy adult smokers between 18 and 55 years of age who are first or second degree relatives (e.g., siblings, children, grandchildren, nieces, nephews, grandnieces or grandnephews) of a patient with advanced lung cancer who is receiving care at the Moffitt Cancer Center and Research Institute in Tampa, Fla. and the GUMC/LCCC, may be eligible for this study. Participants must be able to complete computer online surveys.
Participants log on to a password-protected website to complete online educational sessions and surveys. The educational sessions include information on: 1) the role of smoking and genetics in the development of lung cancer; 2) glutathione S transferase (GSTM1), an enzyme made by the GSTM1 gene that "cleans up" toxins such as cigarette smoke and that may play a role in preventing lung cancer from developing; 3) pros and cons of being tested for GSTM1; and 5) a series of questions and answers about genetic testing. Participants are offered free genetic testing for GSTM1, and those who wish to be tested are sent materials to collect a sample from inside the cheek using a mouth rinse and return it to a laboratory at Duke University Medical Center. They later receive their results online.
Participants also complete online surveys that ask about their risk perceptions, beliefs and attitudes related to lung cancer, emotional responses to their relative's diagnosis, smoking history and motivation to quit, reactions to information about smoking and genetic risk, and interest in receiving smoking cessation services. They are asked to review depictions and descriptions of smoking cessation materials offered through a quit smoking program at Duke University Medical Center and to evaluate the extent to which the various materials might be helpful. They are offered additional information among categories they can choose from.
Participants are surveyed again by telephone 6 months after completing the online surveys.
Conditions: Lung Cancer
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | * INCLUSION CRITERIA:
The target sample for the study is healthy adult smokers ages 18 to 55 who are first or second degree blood relatives (e.g., siblings, sons, daughters, grandsons, granddaughters, nieces, nephews, grandnieces, grandnephews) of a late stage lung cancer patient (Stage IIIB or IV) who is receiving care at MCC.
Aside from age and blood relationship to the lung cancer patient, eligibility criteria also will include the following:
No current or previous diagnosis of cancer;
Has access and some willingness to use the internet;
Is willing to be contacted by NIH study staff;
Has a score lower than 14 on the Centers for Epidemiological Survey of Depression (CESD);
Is English speaking. | 2,448 |
Study Objectives
RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.
Conditions: Kidney Cancer
Intervention / Treatment:
GENETIC: DNA analysis, GENETIC: nucleic acid amplification, OTHER: diagnostic laboratory biomarker analysis, OTHER: medical chart review
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* DNA samples from FHWT patients registered on:
* NWTS-4
* NWTS-5 with focal and diffuse anaplasia tumors
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified | 43,420 |
Study Objectives
This phase I trial studies the side effects and best dose of PLX51107 and how well it works with azacitidine in treating patients with acute myeloid leukemia or myelodysplastic syndrome. PLX51107 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving PLX51107 and azacitidine may work better than azacitidine alone in treating patients with acute myeloid leukemia or myelodysplastic syndrome.
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm
Intervention / Treatment:
DRUG: Azacitidine, DRUG: BRD4 Inhibitor PLX51107
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
* Diagnosis of
* AML (World Health Organization \[WHO\] classification definition of \>= 20% blasts), or
* MDS intermediate-2 score or with \> 10% blasts, to include: MDS, myeloproliferative neoplasm (MPN) with 10% blasts or more, or MDS/MPN 10% blasts or more
* Patients who have received at least one prior therapy for AML or for MDS will be eligible. Any prior therapy for AML or MDS will be counted as a prior salvage
* In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for cytotoxic/non-cytotoxic agents. The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochures, or drug-administration manuals) and will be documented in the protocol eligibility document. The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions:
* Intrathecal (IT) therapy for patients with controlled central nervous system (CNS) leukemia at the discretion of the principal investigator (PI). Controlled CNS leukemia is defined by the absence of active clinical signs of CNS disease and no evidence of CNS leukemia on the most recent 2 simultaneous cerebrospinal fluid (CSF) evaluations
* Use of one dose of cytarabine (up to 2 g/m\^2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. These medications will be recorded in the case-report form.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Measured or calculated creatinine clearance \>= 60 mL/min (unless considered due to leukemia)
* Total bilirubin \< 1.8 mg/dL (unless increase is due to hemolysis, congenital disorder, or leukemia)
* Transaminases (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x upper limit of normal (ULN) (unless considered due to leukemia)
* Potassium levels should be within institutional normal limits (unless considered due to leukemia)
* Magnesium levels should be within institutional normal limits (unless considered due to leukemia)
* Calcium (normalized for albumin) levels should be within institutional normal limits (unless considered due to leukemia)
* Ability to take oral medication
* Ability to understand and provide signed informed consent prior to any study-related procedures and to comply with all study requirements
* Baseline left ventricular ejection fraction by echocardiogram (ECHO) or multigated acquisition scan (MUGA) \>= 50%
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
* WOCBP must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy until after the last dose of investigational drug. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as men with azoospermia do not require contraception
Exclusion Criteria:
* Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PLX51107
* Patients with any other known concurrent severe and/or uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed
* Patients with known positive human immunodeficiency virus (HIV), hepatitis B or C infection by serology, with the exception of those with an undetectable viral load within 3 months. (HIV testing and hepatitis B or C testing is not required prior to study entry). Subjects with serologic evidence of prior vaccination to hepatitis B virus (HBV) (i.e., hepatitis B virus surface antigen negative \[HBs Ag-\], and hepatitis B surface antibody positive \[HBs+\]) may participate
* Patients with advanced malignant hepatic tumors
* Patients with known hypersensitivity to AZA or mannitol
* Women who are pregnant or are breast-feeding
* Patients who receive strong CYP3A4 and CYP2C8 inhibitors or inducers or CYP3A4 substrate drugs with a narrow therapeutic range, taken within 14 days or 5 drug half-lives, whichever is longer, before start of study drug
* Patients who have received anti-cancer therapy within 14 days (or 5 half-lives) with all toxicities resolved to grade 1 or less. No immune therapy or other biologic therapy (other monoclonal antibodies or antibody-drug conjugates \[ADCs\]) within 28 days of cycle 1 day 1 | 36,829 |
Study Objectives
Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.
Neurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.
The objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.
Conditions: Carotid Artery Stenosis, Glioma, Intracranial Aneurysm, Intracranial Hemorrhages, Brain Tumor
Intervention / Treatment:
DIAGNOSTIC_TEST: biological samples analysis
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Age 18-80 years
* Any type of neurosurgery
Exclusion Criteria:
·refusal of the patient to participate | 38,277 |
Study Objectives
A Phase 1b/2 multi-centre study evaluating the safety, efficacy and immunogenicity of prime-boost vaccines ChAdOx1-HPV and MVA-HPV in women with HPV related low grade cervical lesions.
Conditions: HPV Infection, CIN1
Intervention / Treatment:
BIOLOGICAL: ChAdOx1-HPV, BIOLOGICAL: MVA-HPV, BIOLOGICAL: Placebo
Location: Estonia, United Kingdom, Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: QUADRUPLE | Inclusion Criteria:
1. Females aged ≥25 and ≤55 years of age at screening.
2. Persistent hrHPV infection defined as a documented cervical infection with hrHPV type(s) in the 6 to 18 months prior to screening and confirmed at screening (participants in the main and expansion phases only). Participants in the lead-in phase are only required to have the screening result.
3. Low- grade cervical lesion (CIN1 or HPV-related change only) confirmed by histology and/or cytology report within the 1 year prior to screening.
4. Not pregnant or breast feeding and one of the following:
* Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses for at least 12 months and without an alternative medical cause)
* Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to administration of the first dose of study vaccine and throughout the study until 8 weeks after administration of the second dose. Highly effective methods of contraception include one or more of the following:
* Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant
* Hormonal (oral, intravaginal, transdermal, implantable or injectable). Progestogen-only hormonal contraceptives without inhibition of ovulation are not considered to be highly effective.
* An intrauterine hormone releasing system
* An intrauterine device
* Bilateral tubal occlusion
* Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant
5. Willing to abstain from sexual activity for 48 hours prior to all swabbing procedures
Exclusion Criteria:
1. Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness, including blood dyscrasias.
2. Immunosuppression as a result of underlying illness or treatment including:
* Use of high dose corticosteroids ( \>10 mg/day prednisone or equivalent) for ≥7 days (inhaled, otic and ophthalmic corticosteroids are permitted)
* Primary immune deficiency disease
* Use of synthetic or biologic disease-modifying antirheumatic drugs
* History of bone marrow or solid organ transplant
* History of any other clinically significant autoimmune or immunosuppressive disease
3. Positive diagnostic tests (for human immunodeficiency virus, hepatitis B or hepatitis C) indicating chronic infection.
4. Evidence of high grade cervical lesions by colposcopy or by Papanicolaou (Pap) smear test in the 1 year prior to screening.
5. Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine, e.g. severe allergy to eggs.
6. Receipt of any investigational drug or investigational vaccine within 3 months prior to administration of ChAdOx1-HPV on Day 0, or prior participation in a clinical study of any HPV vaccine.
7. Receipt of any adenoviral based vaccine within 3 months prior to administration of ChAdOx1 HPV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0.
8. Receipt of any live vaccines within the 30 days or inactivated vaccine within the 14 days prior to administration of ChAdOx1-HPV on Day 0 or planned to occur in the 2 months after the Day 0 vaccination.
9. Current or history of illicit drug use within the 6 months prior to screening.
10. Current or history of severe alcohol abuse within the 6 months prior to screening.
11. Any laboratory test which is abnormal and deemed by the Investigator to be clinically significant which will potentially affect the participation in the study.
12. Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS CoV-2)
13. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study. | 13,534 |
Study Objectives
Indications for post-hysterectomy radiation therapy (RT) have been well established by clinical data. Adjuvant RT has demonstrated local control and survival benefit. In patients with nodal disease, adjuvant chemotherapy concurrent with radiation has further improved the clinical outcome. The acute hematological and gastrointestinal toxicity of concurrent chemo-radiotherapy can be quite high, sometimes preventing patients from completed their full treatment course, potentially compromising the therapeutic benefit of treatment. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. Helical tomotherapy is a novel treatment device with sophisticated imaging and treatment delivery features that are optimally suited for IMRT. There are retrospective clinical data supporting the use of non-tomotherapy delivered IMRT to treat patients with gynecologic cancers. The proposed study will prospectively test whether helical tomotherapy is a feasible method for delivering IMRT in post-hysterectomy cervical cancer patients receiving adjuvant RT. Here, the question of feasibility is simply one of verifying that target volumes are reliably covered by 'sculpted' IMRT high-dose regions. Although this is not a treatment effectiveness study, we will also follow the clinical outcome of these patients, including toxicity, local control and survival, in anticipation that this information will be valuable if the treatment modality is judged feasible and will be used for further treatments of this patient population.
Conditions: Uterine Cervical Neoplasms
Intervention / Treatment:
RADIATION: IMRT with tomotherapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Age \>= 18
* Karnofsky Performance Status of \>= 60
* FIGO Stage I -IIB
* Pathologic confirmation of cervical cancer
* Status post hysterectomy
* Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
Exclusion Criteria:
* Age \< 18
* Karnofsky Performance Status \< 60
* Radiographic or pathologic evidence of distant metastatic disease
* Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy irradiation for acute hemostasis | 22,273 |
Study Objectives
RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function.
PURPOSE: This randomized phase I trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage I, stage II, or stage III cervical cancer.
Conditions: Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment
Intervention / Treatment:
BEHAVIORAL: Psychosocial Telephone Counseling (PTC)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | INCLUSION CRITERIA
Disease Characteristics:
* Diagnosis of cervical cancer between the past 3-15 months
* Stage I-III disease
* Completed therapy for cervical cancer ≥ 1 month ago
* Not receiving ongoing treatment
* More than 4 weeks since prior immunotherapy
* More than 30 days since prior investigational drugs
* No prior biological response modifier
* No concurrent corticosteroids
* No concurrent immunosuppressive therapy
Patient Characteristics:
* Resident of Orange, San Diego, or Imperial County in California
* English or Spanish speaking
* No serious acute or chronic illness
* Has access to a telephone
EXCLUSION CRITERIA
Disease Characteristics:
* Stage IV cervical carcinoma
* Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment
* Used investigational drugs within 30 days of execution of the informed consent
* Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection
* Patients with metastatic disease or ongoing treatment
* Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators
Patient Characteristics:
* Non-English or Spanish speakers | 32,799 |
Study Objectives
This phase II trial is studying how well giving bevacizumab together with lenalidomide and dexamethasone works in treating patients with relapsed or refractory stage II or stage III multiple myeloma. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Dexamethasone may stimulate the immune system in different ways and stop cancer cells from growing. Giving bevacizumab together with lenalidomide and dexamethasone may kill more cancer cells.
Conditions: Multiple Myeloma in Relapse, Stage II Multiple Myeloma, Stage III Multiple Myeloma
Intervention / Treatment:
BIOLOGICAL: bevacizumab, DRUG: lenalidomide, DRUG: dexamethasone
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically confirmed symptomatic multiple myeloma:
* Stage II or III disease
* Relapsed or refractory disease after \>= 2 courses of prior chemotherapy
* Measurable levels of monoclonal protein (M protein) \> 1.0 g/dL by serum protein electrophoresis OR \> 200 mg of monoclonal light chain by 24-hour urine protein electrophoresis
* Measurable bone disease, defined as \>= 1 unidimensionally measurable lesion (longest diameter to be recorded) \>= 20 mm with conventional techniques OR \>= 10 mm with spiral CT scan (for patients with lytic bone disease)
* No known brain metastases
* ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%
* Patients with PS of 3 are eligible if it is due to pain that is likely to improve with treatment
* Life expectancy \> 6 months
* No known HIV positivity
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No active infections requiring oral or intravenous antibiotics within the past week
* No proteinuria (i.e., albuminuria) \> 1,000 mg/24 hours unless related to the diagnosis of multiple myeloma
* Patients with light chain (i.e., "Bence-Jones") proteinuria are still eligible if the non-light chain component of protein is \< 1,000 mg/24 hours
* No serious nonhealing wound or ulcer
* No blood pressure \> 150/90 mm Hg (even with medication)
* No significant traumatic injury within the past 28 days
* No clinically significant peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No unstable angina or myocardial infarction within the past 6 months
* No stroke within the past 6 months
* No New York Heart Association class III or IV heart failure
* No secondary malignancy within the past 2 years except squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Hemoglobin \> 9 g/dL (may be supported by transfusion or growth factors)
* WBC \>= 2,000/mm\^3
* Absolute neutrophil count \>= 1,000/mm\^3
* Platelet count \>= 75,000/mm\^3
* Bilirubin =\< 2.5 mg/dL
* At least 4 weeks since prior chemotherapy or radiotherapy and recovered
* More than 7 days since prior minor surgical procedures, fine-needle aspirations, or core biopsies:
More than 24 hours since prior bone marrow biopsy or central veinous access placement
* More than 28 days since prior major surgical procedure or open biopsy
* At least 4 weeks since prior and no concurrent participation in another experimental drug study
* Prior autologous peripheral blood stem cell transplantation allowed
* No prior lenalidomide
* Concurrent full-dose anticoagulants allowed provided all of the following criteria are met:
* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
* No thrombocytopenia requiring transfusion
* Platelet count \> 75,000/mm3
* INR 2-3 and stable
* No concurrent major surgery
* No concurrent sargramostim (GM-CSF)
* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies
* AST and ALT =\< 5 times upper limit of normal
* Creatinine \< 2.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and 4 weeks after completion of study treatment
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide and/or bevacizumab or other agents used in the study | 44,729 |
Study Objectives
The primary objective of the study is to assess the anti-tumor activity of REVLIMID® (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and response duration.
Conditions: Thyroid Neoplasms
Intervention / Treatment:
DRUG: Lenalidomide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological confirmation of follicular, papillary, insular, or Hürthle-cell thyroid carcinoma. Histologic slides and/or tissue blocks must be reviewed at the University of Kentucky Medical Center.
* Patients must have an unresectable, distantly metastatic tumor, which does not concentrate radioactive iodine. Alternatively, follicular or papillary thyroid carcinoma patients with large distant tumor burdens which have not sufficiently responded to more than 800 mCi I-131 cumulative therapy and are progressive (criteria #4) may be appropriate for inclusion.
* No systemic chemotherapy agents within 4 weeks of initiation of therapy.
* Patients must have 3 consecutive radiographic evaluations demonstrating a cumulative 30% increase in tumor volume over a period of one year or less.
* Patients must be over the age of 18 years with the ability to understand and willing to sign an informed consent.
* Non-pregnant (if female). Women of childbearing potential (fertile females) must have a negative serum or urine pregnancy test within one day of starting study drug. In addition, sexually active fertile female subjects must agree to adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation, intrauterine device, barrier contraceptive with spermicide; or vasectomized partner) while on study drug. Men must agree to use latex condoms when having sex with fertile women.
* Karnofsky performance status ≥ 70.
* Baseline laboratory studies:
* absolute neutrophil count (ANC) \> 1000/mm3
* platelet count ≥ 100 K/mm3
* creatinine ≤ 1.5 mg/dL, and
* transaminase levels (AST/SGOT, ALT/SGPT) ≤ 2 x upper limit of normal (ULN) (or ≤ 5 x I:M if hepatic metastases are present)
* Disease free of other prior malignancies for ≥ 5 years, with the exception of currently treated basal cell/squamous cell carcinoma of the skin or "in-situ" carcinoma of the cervix or breast.
* Thyroid stimulating hormone (TSH, thyrotropin) levels must be suppressed with sufficient levothyroxine to be kept beneath the normal range of the assay.
Exclusion Criteria:
* Patients may not have had prior REVLIMID® therapy.
* No serious concomitant medical or psychiatric illness that might interfere with informed consent or conduct of the study, including active infections that are not controlled with medication.
* Patients must not be pregnant or breastfeeding.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide.
* The development of erythema nodosum, characterized by a desquamating rash, while taking thalidomide or similar drugs.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Concurrent use of other anti-cancer agents or treatments, with the exception of thyrotropin-suppression by levothyroxine.
* All subjects with central nervous system involvement, with the exception of those subjects whose central nervous system metastases have been treated with either radiotherapy and/or surgery and remain asymptomatic with no evidence of active central nervous system disease (verified by computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]) for at least 6 months.
* Known to be positive for HIV or infectious hepatitis, type A, B, or C.
* Patients with medullary or anaplastic thyroid carcinomas are excluded. Patients whose disease is limited to bone metastases are excluded. | 28,787 |
Study Objectives
This pilot clinical trial studies a breast and cervical cancer educational intervention for Latinas in Western New York. An outreach program may help minority cancer patients overcome problems that keep them from receiving cancer screening.
Conditions: Breast Cancer, Cervical Cancer
Intervention / Treatment:
OTHER: educational intervention, OTHER: educational intervention, OTHER: questionnaire administration
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Men and women who are generally healthy, ambulatory, and able to participate in social events in their communities
* No women, men, or children of any ethnic or social background are ever excluded from the educational programs, although recruitment will focus on Hispanic/Latinos
* Children may be present with parents, but will not be included in any research activities, unless they are emancipated minors (under 18 and married)
* Men are included in all of the research activities, but will not be included in the follow-up telephone surveys to assess breast and cervical screening as they do not obtain screening Pap smears, clinical breast exams, or mammograms; men may be asked about their intent to assist women in obtaining screening | 12,525 |
Study Objectives
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Patients will receive study drug as a single IV infusion. Cycles will continue until disease progression or unacceptable toxicity.
Conditions: HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer, Salivary Gland Cancer, Salivary Gland Tumor, Salivary Gland Carcinoma, Salivary Gland Neoplasms, Lung Cancer, Colo-rectal Cancer, Rare Diseases, Solid Tumor, Recurrent Gastric Cancer, Recurrent Colon Cancer, Recurrent Breast Cancer, Head and Neck Cancer, Head and Neck Carcinoma, Bladder Cancer, Cervical Cancer, Liver Cancer, Bile Duct Cancer, Urologic Cancer, Pancreatic Cancer, Prostate Cancer, Recurrent Prostate Cancer, Rectal Cancer, Recurrent Ovarian Carcinoma, Recurrent Renal Cell Cancer, Rectal Cancer Stage II, Rectal Cancer Stage I, Rectal Cancer Stage III, Skin Cancer, Mouth Cancer, Lip Cancer Stage I, Tongue Cancer, Breast Neoplasm Malignant Primary, Larynx Cancer, Tonsil Cancer, Palate Cancer, Mucoepidermoid Carcinoma, Primary Peritoneal Carcinoma, Mucinous Adenocarcinoma Gastric, Mucinous Breast Cancer Recurrent, Cholangiocarcinoma
Intervention / Treatment:
DRUG: A166
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
Phase I
Patients must meet the following criteria for inclusion into the study:
1. Patients must be able to provide documented voluntary informed consent.
2. Male or female patient ≥ 18 years.
3. Histologically documented, incurable, locally advanced or metastatic cancer.
4. Evaluable or measurable HER2 positive (by ISH or NGS) disease or HER2 expressing disease. HER2 expressing is defined in this protocol as HER2 expression of ≥ 1+ determined by validated IHC.
5. Patients should have no available therapy likely to convey clinical benefit.
6. Granulocyte count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.
7. Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN).
8. Creatinine clearance ≥ 50 mL/min calculated by Cockroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or Modification of Diet in Renal Disease (MDRD) formulas. Note that 24 hour urine collection is not required but is allowed.
9. ECOG Performance Status ≤ 1.
10. Women of childbearing potential and men must agree to use an approved method of birth control (e.g., hormonal, barrier) while receiving study drug, and for at least 7 months after the last dose of study drug. Women are excluded from birth control if they had had tubal ligation or a hysterectomy.
11. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo.
Exclusion Criteria:
Phase I:
1. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
2. History of Grade ≥ 3 hypersensitivity reaction to trastuzumab.
3. History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued.
4. Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first infusion of study drug.
5. Require supplemental oxygen for daily activities.
6. Documented Grade ≥ 2 peripheral neuropathy.
7. Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks of first infusion of study drug.
8. Any experimental therapy within 4 weeks of first infusion of study drug.
9. Any major surgical procedure within 4 weeks of first infusion of study drug.
10. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis. Patients who have positive hepatitis B virus test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti hepatitis B core protein, and positive antibody to the HBsAg (anti-HBs) are not excluded.
11. Have known prior positive test results for human immunodeficiency virus.
12. Uncontrolled hypertension or diabetes.
13. Pregnancy or lactation.
14. Resting corrected QT interval (QTc) \> 470 ms at baseline.
15. Left ventricular ejection fraction (LVEF) \< 45% determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
16. Prior cumulative doxorubicin dose of \> 360 mg/m2 or equivalent. | 12,917 |
Study Objectives
This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin) metabolism during breast cancer treatment.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: CoQ10, OTHER: CoQ10 Placebo, DRUG: Doxorubicin, DRUG: Cyclophosphamide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: TRIPLE | Inclusion Criteria:
* Diagnosis of early stage breast cancer (stage I, II, or III);
* Scheduled to receive at least four rounds of dose dense doxorubicin therapy in the neoadjuvant or adjuvant setting;
* No other history of prior chemotherapy, radiation, or hormonal therapy in the previous 5 years;
* For women receiving adjuvant therapy, single lumen implanted venous access device (i.e. single port) for unilateral cancer and double lumen implanted venous access device (i.e. double port) for bilateral breast cancer
* Age 21 years or older;
* ECOG performance status ≤ 2 (Karnofsky \> 60%);
* Normal organ and marrow function defined as: Leukocytes ≥ 3,000/uL, Absolute neutrophils count (ANC) ≥ 1,500/uL at baseline, Platelets ≥ 100,000/uL, Total bilirubin ≤ 1.5 X normal institutional limits, AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional ULN, Serum creatinine within normal institutional limits;
* Left ventricular ejection fraction \> 55%;
* No history of CoQ10 supplement use within 30 days of initiating study drug;
* No uncontrolled or significant co-morbid illness;
* Not pregnant, not breastfeeding, and not planning on becoming pregnant during the course of the study;
* Willingness to comply with all study intervention and follow-up procedures;
* Ability to speak English or Spanish; and
* Ability to provide informed consent.
Exclusion Criteria:
* Inability to understand or an unwillingness to sign a written informed consent document;
* Any significant toxic side effects related to first or second dose of doxorubicin/cyclophosphamide chemotherapy or biologic therapy that did not resolve to less than a CTCAE 3.0 grade 3 non-hematological toxicity;
* Currently using any investigational agent;
* Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with the participant's ability to follow the protocol or achieve study objectives;
* Psychological or sociological conditions, addictive disorders, or family problems that would preclude adherence with study drug or compliance with the protocol
* Women who report pregnancy, are breast feeding, or have a positive pregnancy test;
* Use of CoQ10 supplement use within 30 days of initiating study drug;
* Use of over-the-counter nutritional vitamin greater than 5x RDA;
* Fish allergy (due to fish-based softgel shell);
* Currently taking FDA cardioprotective drugs, such as Zinecard (dexrazoxane);
* History of chronic hepatitis B, hepatitis C, and HIV infection;
* Problems swallowing oral medications due to prolonged emesis, mucositis, esophageal dysfunction, etc.; and,
* Currently taking any form of antioxidant supplements while on study.
* Use of warfarin.
* Kosher (due to fish-based softgel shell)
* Dietary restriction of tilapia (due to tilapia fish-based softgel shell)
* Titanium Dioxide allergy (due to the opaque coloring used in the softgel). | 20,352 |
Study Objectives
The primary objective is to determine the nature and degree of the toxicity of weekly dosing of topotecan in escalating dose levels by cohorts of 3-6 patients in combination with a fixed dose of pegylated liposomal doxorubicin (Doxil).
The secondary objective is to determine the activity of weekly topotecan and pegylated liposomal doxorubicin in advanced solid tumors.
Conditions: Small Cell Lung Cancer, Pancreatic Cancer, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer
Intervention / Treatment:
DRUG: Topotecan and pegylated doxorubicin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* ECOG functional status of 2 or better is required.
* The patient should be able to provide informed consent.
* Prior treatment with Doxil or topotecan is not permitted.
* Prior treatment with doxorubicin is permitted if the total dose was 350 mg/m2 or less. Prior treatment with epirubicin is permitted if the total dose was 560 mg/m2.
* Patients with controlled brain metastases will be considered eligible for therapy (i.e. metastases surgically removed; or irradiated metastases with stable neurologic function).
* Patients must have measurable disease (the presence of at least one measurable lesion).
* If previously irradiated lesions are to be used to measure response, documented growth of the lesions must have been observed following completion of radiation therapy.
* Patients must have a life expectancy of at least four weeks.
* Hematologic criteria: patients must have absolute neutrophil count (ANC) of 1200 or better; platelet count of 100,000/mm3 or better; hemoglobin (Hgb) ≥ 9.0g/dL.
* Hepatic criteria: bilirubin must be less than or equal to 1.7. SGOT, SGPT may be up to 2 x institutional upper limit of normal (ULN) but with the presence of liver metastasis the SGOT, SGPT may be up to 3 x institutional ULN.
* Serum creatinine must be \< 1.5 mg/dl x ULN
* Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
* Patients must have a multigated acquisition (MUGA) scan or 2-d echocardiogram indicating an ejection fraction of ≥ 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.
Exclusion Criteria:
* Patients with concurrent severe medical problems unrelated to malignancy, which would limit full compliance to the study or expose the patient to extreme risk with decreased life expectancy, are ineligible.
* Patients with previous or concomitant malignancy other than curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other primary cancer completely resected or treated within five years are ineligible. Exceptions are patients who have had tumors treated with no evidence of active disease who are felt by both the enrolling physician and the principal investigator (PI) to have a risk of relapse of less than 30%.
* Pregnant or lactating women.
* History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride (HCL) or the components of Doxil®.
* History of cardiac disease with New York Heart Association Class III or greater, or clinical evidence of congestive heart failure. | 19,176 |
Study Objectives
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.
Conditions: Malignant Neoplasm of Breast
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Physician inclusion criteria
* Oncologist or gynecologist
* Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.
* Agrees to participate in the study and complete the eCRFs within the data collection period.
Patient inclusion criteria
* Female
* ≥18 years old.
* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
* Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).
* No prior or current enrolment in an interventional clinical trial for ABC/MBC.
* Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).
* Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).
* Inoperable or recurrent breast cancer (Japan only)
Exclusion criteria:
Physician exclusion criteria
* Qualified less than 2 years ago or more than 35 years ago
* Participated in observational research for ABC/MBC in the last 3 months
* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s). | 14,856 |
Study Objectives
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).
This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.
Conditions: Primary Parathyroid Adenomas
Intervention / Treatment:
DEVICE: Ultrasonic ablation device
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Male or female patient 18 years or older.
* Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
* One diseased parathyroid gland, visualized by ultrasonography.
* The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
* Normal pretreatment nasofibroscopy.
* Voluntary signed informed consent.
Exclusion Criteria:
* Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:
* Targeted area located less than 2 mm laterally from the oesophagus or the carotid artery
* Targeted area located less than 3 mm laterally from the trachea,
* Significant hyperechoic area with a posterior shadow located less than 10 mm behind the targeted area (behind to be understood as posterior to the targeted area in the direction of the HIFU beam)
* Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
* Known spondylitis of the neck vertebrae
* Head and/or neck disease that prevents hyperextension of neck.
* Known history of parathyroid or other neoplasias in the neck region.
* History of neck irradiation
* Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit
* Pregnant or lactating woman.
* Female patient of childbearing age if not having a suitable contraception method.
* Patients who have received any investigational drug or device within the last 15 days and/or patients who are currently participating in another clinical trial. | 7,706 |
Study Objectives
This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and D2 gastrectomy.
Conditions: Gastric Cancer
Intervention / Treatment:
PROCEDURE: Lymphadenectomy type
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy
Exclusion Criteria:
* patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV. | 10,941 |
Study Objectives
This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle.
The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: BIBW 2992 low dose, DRUG: BIBW 2992 high dose, DRUG: pemetrexed, DRUG: pemetrexed, DRUG: BIBW 2992 high dose 6 day, DRUG: pemetrexed, DRUG: pemetrexed, DRUG: pemetrexed, DRUG: pemetrexed, DRUG: BIBW 2992 low dose 6 day, DRUG: BIBW 2992 medium dose 6 day, DRUG: BIBW 2992 medium dose
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria:
1. Age 18 or older.
2. Eastern cooperative oncology group performance status of 0-2.
3. Life expectancy of at least 12 weeks.
4. Measurable disease according to Response evaluation criteria in solid tumors 1.1 criteria.
5. Written informed consent
Exclusion criteria:
1. Treatment with an investigational drug within the past 28 days prior to the start of therapy
2. Persisting toxicities which are clinically significant from previous therapy
3. Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
4. Active brain metastases
5. Other active malignancy diagnosed within the past 3 years
6. Concomitant intercurrent illnesses that would limit compliance with trial requirement
7. Patients unable or unwilling to interrupt concomitant administration of Non-steroidal anti-inflammatory drugs (NSAIDS) as per pemetrexed prescribing information
8. Patients who have received prior therapy with BIBW 2992
9. Left ventricular function by echocardiogram or Multiple gated acquisition scan (MUGA) less than institutional lower limit of normal
10. Absolute neutrophil count (ANC) less than 1,500/mm3
11. Platelet count less than 100,000/mm3
12. Hemoglobin less than 90g/L
13. Total bilirubin less than 26µmol/L
14. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) greater than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
15. Serum creatinine level greater than 133µmol/L and/or creatinine clearance (measured or calculated) less than 45 ml/min
16. History or recent gastrointestinal bleeding, obstruction or perforation or malabsorption syndrome and must be able to swallow the BIBW 2992 in whole by mouth.
17. History of interstitial lung disease
18. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
19. Pregnancy or breast feeding
20. Known or suspected active alcohol or drug abuse
21. Patients unable to comply with the protocol
22. Has a diagnosis of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
23. Any known hypersensitivity to the trial drugs or their excipients | 32,744 |
Study Objectives
This phase II trial studies how well brivanib alaninate works in treating patients with cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Persistent Disease, Recurrent Cervical Carcinoma
Intervention / Treatment:
DRUG: Brivanib Alaninate, OTHER: Laboratory Biomarker Analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must have persistent or recurrent squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma, or non-squamous cell carcinoma of the cervix with documented disease progression (disease not amenable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report
* All patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
* Patient must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1
* Tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
* Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
* In general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population
* Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2
* Patients who have received two prior regimens must have a GOG performance status of 0 or 1
* Recovery from effects of recent surgery, radiotherapy, or chemotherapy
* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
* Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration
* Any prior radiation therapy must be completed at least 4 weeks prior to registration
* At least 4 weeks must have elapsed from the time of any major surgical procedure
* Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix; chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
* Patients must have NOT received any non-cytotoxic (biologic or targeted) agents as part of their primary treatment or for management of recurrent or persistent disease
* Non-cytotoxic (biologic or targeted) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
* Platelets greater than or equal to 100,000/mcl
* Hemoglobin \>= 9 g/dl
* Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
* Urinalysis needs to be assessed at baseline and proteinuria must be less than or equal to 2+ by dipstick
* If the urine dipstick is \> 2+, a 24-hour protein level can be done, as clinically indicated by the investigator
* The 24-hour protein level must be less than or equal to 3.5 g/24 hours
* Bilirubin less than or equal to 1.5 x ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
* Alkaline phosphatase less than or equal to 2.5 x ULN
* Albumin greater than or equal to 2.5 g/dl
* Neuropathy (sensory and motor) less than or equal to grade 1
* Prothrombin time (PT) such that international normalized ratio (INR) is =\< 1.5 x ULN; patients on therapeutic warfarin are excluded from trial, anticoagulation with low molecular weight heparin is allowed
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
* Patients of childbearing potential must have a negative serum pregnancy test performed 48 hours prior to study entry and be practicing an effective form of contraception during the study and for at least 3 months after receiving the final treatment of brivanib
* All patients must have a baseline electrocardiogram completed prior to study entry
* Baseline electrocardiogram (ECG) should be repeated if corrected QT interval (QTc) is found to be \> 450 msec; QTc must NOT be \> 450 msec on both ECGs performed during the same visit
Exclusion Criteria:
* Patients who have had prior therapy with brivanib or anti-vascular, anti-PDGFR (platelet-derived growth factor receptor) or anti-FGFR (fibroblast growth factor receptor) therapy
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of the other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last three years are excluded
* Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
* Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded
* Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
* Patients that are on required chronic anti-platelet therapy (aspirin \> 300 mg/day, or clopidogrel greater than or equal to 75 mg/day)
* Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event \>= grade 3 of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) within 30 days prior to study entry
* Patients with a history of poor wound healing, non-healing ulcers, or bone fractures within the last 3 months
* Patients with uncontrolled or significant cardiovascular disease including any of the following:
* Myocardial infarction within 12 months
* Uncontrolled angina within 12 months
* Class III-IV New York Heart Association (NYHA) congestive heart failure
* Uncontrolled hypertension despite anti-hypertensive therapy
* Blood pressure (BP) must be less than or equal to 140/90 at screening
* Subjects with a history of hypertension who are receiving treatment with calcium channel blockers that are cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors should be changed to an alternative antihypertensive medication before study entry
* History of stroke, transient ischemic attack (TIA), or other central nervous system (CNS) ischemic event
* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
* Patients must have pre-therapy left ventricular ejection fraction (LVEF) testing and have an ejection fraction \>= institutional lower limit of normal (LLN)
* Patients with valvular heart disease \>= grade 2
* Patients with a serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
* Patients with hyponatremia (sodium \< 130 mEq/L)
* Patients with active/known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; HIV-positive subjects on combination antiretroviral therapy are ineligible
* Patients with known brain metastases
* Patients who are pregnant or nursing
* Patients with inability to swallow tablets or untreated malabsorption syndrome
* Patients with baseline serum potassium \< 3.5 mmol/L (potassium supplementation may be given to restore the serum potassium above this level prior to entry study)
* Patients on therapeutic warfarin anticoagulation are excluded
* Patients converted to anticoagulation with low molecular weight heparin will be allowed provided the patient?s PT is such that INR is =\< 1.5 x ULN | 38,992 |
Study Objectives
Cancer cachexia syndrome (CCS) is frequent, causing high morbidity and mortality in affected ones. The mechanism is catabolism caused by the tumour. CRP is a surrogate marker for catabolism. There are no effective treatment options against CCS. Lenalidomide, a derivate of thalidomide, is an immunomodulatory drug (IMiD®). One of its' main effect is a decrease in inflammatory cytokines. As CCS treatment, thalidomide has shown in a randomized controlled trial to stabilize lean body mass. The effect of lenalidomide in solid tumour patients was negligible although, there might be a decrease in tumour progression. However, even if lenalidomide may be uninteresting as an anticancer treatment it might affect CCS dynamics. Respective data are currently lacking. Therefore, a dose level where an anticancer effect could be expected was chosen (group A). Relevant anti-inflammatory effect may occur below the commonly used doses to achieve tumour control, which is expected to be the main anti-cachexia effect. Therefore, a second CRP-response guided treatment arm (group B) was chosen.
Hypothesis: To test whether the response rate under new standard basic cachexia management will be at the estimated 5% and with lenalidomide (either fixed dose or CRP-guided dose) in addition to basic cachexia management at least 25%.
The primary objective of this study is to assess the efficacy of lenalidomide on lean body mass and handgrip strength in advanced solid tumour patients with inflammatory CCS.
Conditions: Cancer Cachexia Syndrome
Intervention / Treatment:
DRUG: Lenalidomide, DRUG: Lenalidomide, OTHER: basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)
Location: Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
1. Age: Patients must be older than 18 years of age.
2. Tumour situation: Patients with any type of advanced (defined as locally recurrent or metastatic), incurable solid tumour.
3. Cachexia: Presence of CCS, defined as involuntary loss of weight of ≥2% in 2 months or ≥5% in 6 months, which is ongoing in the last 4 weeks, and lack of fluid retention.
4. Inflammation: CRP must be ≥ 30mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder.
5. No simple starvation: Patients must be able to eat, defined as no severe structural barriers in the upper gastrointestinal tract and no bowel obstruction.
6. Life expectancy, physical performance: Patient must have an expected life expectancy \> 3 months according to palliative performance (Pap) score and a WHO performance status (PS) ≤ 2.
7. No anti-cachexia or appetite-stimulating medications: Patients are not allowed to have corticosteroids unless for maximum 2 days per week for chemotherapy, progestin therapy, Cyclooxigenase-2 inhibitor (COX-2 inhibitor), and anabolic drugs 28 days before start of trial medication until study conclusion. Prokinetic medication, NSAR, paracetamol and novamin sulphate are allowed, if given in a fixed dose for two weeks before visit 1, and expected to be given during the whole trial period.
8. Laboratory test results: Granulocyte count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, serum creatinine ≤ 2.0 mg/dL (177 μmol/L), creatinine clearance ClCr ≥ 50ml/min, total bilirubin ≤1.5 mg/dL (25μmol/L), and AST (SGOT)/ ALT (SGPT) ≤2 x ULN or if hepatic metastases are present ≤ 5 x ULN.
9. No other trial: Patient is not participating any other clinical intervention 28 days before start of trial medication until study conclusion.
10. Women of childbearing potential (see Annex 1): A negative pregnancy test \& effective contraception are mandatory in child-bearing age.
* A female of childbearing potential (FCBP) is a sexually mature woman who: 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).
* A FCBP potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mU/mL within 10 to 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
* FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See (Annex 2): Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
11. Cognition: Presence of a normal level of consciousness (mandatory is a normal abbreviated screening mini-mental test or a common mini-mental ≥ 27/30; in elderly patients age ≥ 65 years or patients with low education a mini mental status of ≥25/30 points will be considered adequate).
12. Logistics: The patient is able to comply with the study schedule and procedures (including fasting for blood draws on certain visits)
13. Consent: The patient has voluntarily signed and dated the informed consent (IC), approved by the Ethics Committee (EC), prior to any study-specific procedures.
* Will consent to the use of asprin (100mg) or low molecular weight heparin (if intolerant to aspirin) in prophylactic dose (e.g. Fragmin 2500U sc od).
* Study participant agrees to be registered in the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.(Appendix 18)
Exclusion Criteria:
1. Untreated secondary causes of cachexia (oral thrush, nausea, vomiting, constipation, diarrhoea, pain VAS\>3, depression, dyspnoea)
2. CTCAEv3.0 ≥ grade 2 due to anticancer treatment (chemotherapy, radiotherapy or surgery)
3. Any psychiatric disorder, alcohol and illicit drug abuse or language problem that would prevent the patient from filling in the questionnaires adequately or attend study visits according to protocol.
4. Parenteral nutrition
5. Presence of dysthyreosis, defined as TSH beyond normal ranges
6. Presence of long QT syndrome or QTc \> 450ms or under treatment with a QT prolonging drug
7. Presence of lactose intolerance
8. Diabetes mellitus with secondary organ dysfunction (coronary heart disease, previous stroke, renal insufficiency)
9. Patients with cerebral metastases or prophylactic whole brain irradiation for possible cerebral metastases.
10. Known hypersensitivity to thalidomide or a history of development of erythema nodosum due to thalidomide or similar drugs.
11. Any prior use of lenalidomide
12. Known infection with HIV, hepatitis B or C
13. Patients with known myeloid malignancy or tumours having bone marrow involvement.
14. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent (IC) form.
16. Pregnant or breastfeeding females. | 26,930 |
Study Objectives
Lenalidomide has clinical activity in myeloma. The closely related compound, Pomalidomide, may have clinical activity in patients who have previously been treated with lenalidomide and who no longer respond to it. The mechanism of anti-tumor effects of these drugs has been attributed to several effects including anti-angiogenesis, immune activation, and anti-proliferative effects. Recent studies have suggested that these agents can mediate surprisingly rapid biologic effects on human monocytes and T cells. Our hypothesis is that the proximate effects of these drugs will be sensitive and quantitative surrogates of subsequent effects including activation of tumor antigen specific T cells as well as innate immune cells. Understanding the correlation between the pharmacodynamics of these effects with downstream activation using quantitative assays will facilitate the rational development of pomalidomide as immune-modulatory drug in diverse settings as well as its optimal development in myeloma therapy.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Pomalidomide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Understand and voluntarily sign an informed consent form.
* Age ≥18 years at the time of signing the informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements.
* Relapsed / Refractory Multiple Myeloma following at least two prior standard therapies including lenalidomide. Induction therapy followed by autologous stem cell transplantation (ASCT) is considered one regimen.
* Patients must be refractory to prior lenalidomide therapy. For the purpose of this protocol, refractory will be defined as history of progression on a regimen containing full or maximally tolerated dose of lenalidomide administered for a minimum of at least one complete cycle of therapy.
* All patients must have measurable disease defined as one or more of the following criteria:
* Serum monoclonal protein greater than 10 g/L, serum immunoglobulin free light chain (FLC) more than 10 mg/dL and an abnormal FLC ratio, urine light-chain excretion \> 200 mg/24 h, measurable soft tissue plasmacytoma that has not been irradiated, or greater than 30% plasma cells in bone marrow.
* All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
* Eastern Cooperative Oncology Group (ECOG ) performance status of ≤ 2 at study entry (see Appendix D).
* Laboratory test results within these ranges:
* Absolute neutrophil count ≥ 1.0 x 1000/microliter (uL)
* Platelet count ≥ 75 x 1000/uL
* Serum creatinine ≤ 2.5 mg/dL
* Total bilirubin ≤ 2 mg/dL
* aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 5 x upper limit of normal (ULN)
* Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
* Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 milli-international unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A and B: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Education and Counseling Guidance Document.
* Able to take aspirin (ASA) (81 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Exclusion Criteria:
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking pomalidomide).
* Women of child-bearing potential who are unwilling to use a dual method of contraception; and men who are unwilling to use a condom.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide or lenalidomide.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, pomalidomide or similar drugs.
* Any prior use of pomalidomide.
* Concurrent use of other anti-cancer agents or treatments.
* Known positive for HIV or active infectious hepatitis, B or C.
* Grade 3 or 4 peripheral neuropathy | 26,786 |
Study Objectives
This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery.
This study will be performed on patient intended to undergo a liver cancer surgery.It will contain three steps, assessing the following items:
* Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase,
* Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic lesions,
* Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding per-hepatectomy.
3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step.
Patients will be followed during 4 weeks after the surgery.
Conditions: Liver Neoplasms
Intervention / Treatment:
PROCEDURE: Fluobeam
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose:
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Adult patient
* Affected of hepatic cancerous lesions whatever they are
* Requiring a one or two steps hepatectomy by laparotomy
* ECOG performance status (PS)≤ 2
* Mandatory affiliation to health security insurance
* Written informed consent
Exclusion Criteria:
* With a contraindication or hypersensitivity to ICG administration in medical history
* Having already undergone a major hepatic surgery (more than three segments) or major biliar surgery (context of major iterative hepatic surgery)
* Unable to be followed during the duration of the study, for social, family, geographical or psychological reasons
* Pregnant or breast-feeding woman (urinary strip must be negative at the time of the inclusion in the study for women in age to procreate) | 29,628 |
Study Objectives
Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women. The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.
Conditions: Polycystic Ovary Syndrome, Infertility, Pregnancy
Intervention / Treatment:
DRUG: metformin XR, DRUG: clomiphene citrate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: DOUBLE | Inclusion Criteria
* Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer
* Elevated testosterone level
* Good general health
* Sperm concentration in partner of 20 million/ml or greater
* Ability to have intercourse 2-3 times per week
* One functional fallopian tube and normal uterine cavity | 43,236 |
Study Objectives
This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.
Conditions: Cancer
Intervention / Treatment:
DRUG: Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer
Location: Philippines, Singapore, Thailand
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
2. Brain metastasis diagnosis made between January 2006 - December 2008.
Exclusion Criteria:
1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.) | 34,914 |
Study Objectives
This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Eribulin Mesylate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Histological or cytological adenocarcinoma of the breast.
2. Females, aged greater than or equal to 18 years at time of informed consent.
3. HER2-negative as determined by fluorescence in situ hybridization (FISH); or 0 or 1+ by immunohistochemistry (IHC) staining .
4. Participants with metastatic breast cancer who have received at least 2 and not more than 5 prior chemotherapy regimens.
5. Participants with at least one measurable lesion greater than or equal to 10 mm in the longest diameter for a non-lymph node or greater than or equal to 15 mm in the short-axis diameter for a lymph node as determined by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
6. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
7. Life expectancy of greater than or equal to 3 months.
8. Any neuropathy must recover to Grade less than or equal to 2 prior to enrollment.
9. Adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than or equal to 50 mL/minute according to the Cockcroft and Gault formula.
10. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 X 10\^9/L, hemoglobin greater than or equal to 10.0 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 X 10\^9/L.
11. Adequate liver function as evidenced by total bilirubin less than or equal to 1.5 X upper limit of normal (ULN), alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 X ULN (less than or equal to 5 X ULN in the case of liver metastases), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
12. Are willing and able to comply with all aspects of the treatment protocol.
13. Provide written informed consent.
Exclusion Criteria:
1. Previous treatment with eribulin.
2. Hypersensitivity to eribulin/excipients or halichondrin B or known intolerance of eribulin.
3. Current enrollment in another clinical study or used of any investigational drug or device within the past 28 days preceding informed consent.
4. Previous treatment with chemotherapy, radiation, biological, or targeted therapy within the last 2 weeks or 5 X half-life, whichever is longer, preceding informed consent.
5. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin (\[B-hCG\] test). A separate Baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
6. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
7. Females of childbearing potential who had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method \[such as condom plus diaphragm with spermicide\], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
Females who are currently abstinent and do not agree to use a double barrier method as described above or to refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
Females who are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
8. Known central nervous system (CNS) disease, except for those participants with treated brain metastasis who are stable for at least 1 month with no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids.
9. Known human immunodeficiency virus (HIV) positive.
10. Existing anticancer, therapy-related toxicities of Grades greater than or equal to 2, with the exception of alopecia.
11. A prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated greater than 5 years previously with no subsequent evidence of recurrence.
12. Clinically significant cardiovascular impairment (congestive heart failure of New York Heart Association \[NYHA\] Classification greater than II, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia).
13. Clinically significant ECG abnormality, including a marked Baseline prolonged QT/QTc interval (ie, a repeated demonstration of a QTc interval greater than 500 milliseconds).
14. Pulmonary lymphangitic involvement that resulted in pulmonary dysfunction requiring active treatment, including the use of oxygen.
15. History of concomitant medical condition(s) that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study.
16. The investigator's belief that the participant is medically unfit to receive eribulin or unsuitable for any other reason. | 13,478 |
Study Objectives
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
Conditions: Chemotherapy-induced Neutropenia
Intervention / Treatment:
BIOLOGICAL: Balugrastim, DRUG: Pegfilgrastim, DRUG: Chemotherapy Regimen
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel).
Exclusion Criteria:
* Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months). | 21,239 |
Study Objectives
Objective: In this study, it was aimed to determine the effects of health education provided by two different methods on breast cancer and mammography knowledge self-evaluation status, perceived mammography benefit and barrier levels, mammography self-efficacy levels and mammography screening of women aged 40-69 years.
Materials and Methods: The study was conducted in a parallel group design as a single-blind randomized controlled trial. The sample consisted of 126 healthy volunteers, 42 in each group, who were registered to Toprakkale Family Health Center between January and July 2023, met the inclusion criteria. In the study, 10-unit Visual Analogue Scale, mammography benefit and obstacle perception sub-dimension of Champion's Health Belief Model Scale and Mammography Self-Efficacy Scale were used for self-assessment of breast cancer and mammography knowledge. In the study, while the control group received standard care, the face-to-face education group was given health education and brochures through home visits, and a reminder interview was made over the phone. Health education and digital brochures were given to the online training group via video call, and a reminder meeting was held once. After a two-month follow-up, One-Way Analysis of Variance and Kruskal Wallis H test were used to compare the data of the three groups, multiple comparisons were analyzed with Tukey's test and Dunn's test. Generalized Linear Models were used for group and time comparisons.
Conditions: Breast Cancer
Intervention / Treatment:
BEHAVIORAL: Online training group, BEHAVIORAL: Face-to-face training group
Location: Turkey
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Volunteering to participate in the research,
* Being literate in Turkish
* Be in the age range of 40-69 years
* Being a woman
* To have technical equipment to make video calls
Exclusion Criteria:
* Have any communication barrier
* Being pregnant or in puerperium
* Breastfeeding
* To have had a mammogram in the last two years
* Have had a previous benign breast disease or breast cancer
* Having a family history of breast cancer | 30,454 |
Study Objectives
RATIONALE: The amount and type of fat in the diet may affect hormone levels, bone mineral density, and breast density later in life. This may affect the risk of developing breast cancer. Learning about the long-term effects of diet on hormone levels, bone mineral density, and breast density may help the study of breast cancer in the future.
PURPOSE: This clinical trial is studying the long-term effect of adolescent diet on hormones and breast cancer risk in women previously enrolled in the Dietary Intervention Study in Children.
Conditions: Breast Cancer
Intervention / Treatment:
OTHER: physiologic testing, OTHER: questionnaire administration, PROCEDURE: breast imaging study, PROCEDURE: dual x-ray absorptometry, PROCEDURE: evaluation of cancer risk factors, PROCEDURE: magnetic resonance imaging
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Previously enrolled on a clinical trial titled, "Dietary Intervention Study in Children"
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics | 35,632 |
Study Objectives
This research study is studying a chemotherapy as a possible treatment for recurrent glioblastoma that has not responded to bevacizumab. The name of the study drug involved in this study is Ponatinib.
Conditions: Glioblastoma
Intervention / Treatment:
DRUG: Ponatinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Age ≥ 18 years
* Karnofsky performance status ≥ 60
* Participants must have histologically confirmed glioblastoma or variants. Subjects with initial diagnosis of a lower grade glioma are eligible if a subsequent biopsy is determined to be glioblastoma or variants.
* Patients must have an unequivocal progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan. A scan must be performed within 14 days prior to registration and on a steroid dose that has been stable or decreasing for at least 5 days. If the steroid dose is increased between the date of imaging and initiation of study treatment, a new baseline MRI/CT is required.
* Participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm per dimension on MRI performed within 14 days prior to first treatment. If receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline MRI.
* There is no limit on the number of prior relapses but the most recent relapse must be the first relapse on a bevacizumab-containing regimen.
* Participants must have normal organ and marrow function as defined below:
* Leukocytes ≥3,000/mcL (≥ 3,000/mm3)
* Absolute neutrophil count ≥ 1,500/mcL (\> 1,500/mm3)
* Platelets ≥ 100,000/mcL (≥ 100,000/ mm3)
* Total bilirubin ≤ 1.5 X institutional upper limit of normal, unless due to Gilbert's syndrome.
* AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
* Serum Creatinine ≤ 1.5 X institutional upper limit of normal or or creatinine clearance \> 60 mL/min/1.73 m2 (per 24 hour urine collection or calculated according to the Cockcroft-Gault formula) for subjects with creatinine levels above the institutional normal
* Serum lipase and amylase ≤ 1.5 X institutional upper limit of normal.
* Participants must have fully recovered (grade ≤ 1 or baseline or deemed irreversible) from any clinically significant acute toxicity related to prior therapy (with the exception of lymphopenia, which is common after therapy with temozolomide). Patients who discontinued bevacizumab previously due to a bevacizumab-related toxicity will not be allowed to participate.
* The following time periods must have elapsed prior to the planned start date of study treatment:
* ≥2 weeks or 6 half lives from any approved TKIs or investigational agent, whichever is longer
* ≥4 weeks from prior cytotoxic therapy, except ≥ 3 weeks from last dose of temozolomide and ≥6 weeks from nitrosoureas or mitomycin C
* ≥2 weeks from non-cytotoxic agents
* ≥ 3 weeks from bevacizumab
* Participants must have developed progressive disease after receiving prior radiation therapy and must have an interval of at least 12 weeks from the completion of any radiation therapy to study entry (unless progressive tumor growth is outside the radiation field or there is histopathological confirmation of recurrent tumor).
* Participants may not have received prior therapy with any other Src, PDGFR, or FGFR inhibitor. Prior treatment with an anti-VEGFR or anti-VEGF agent is also allowed but only one relapse following a bevacizumab-containing regimen is allowed.
* For females of childbearing potential, a negative serum pregnancy test must be documented prior to registration.
--- NOTE: In addition to screening, serum pregnancy test must be performed on females of childbearing potential within 72 hours before the start of investigational product. When possible, these tests can be one-in-the-same (if screening pregnancy test was performed within 72 hours of first ponatinib dose, no need to repeat).
* The effects of ponatinib on the developing human fetus are unknown. For this reason and because ponatinib is known to be teratogenic in animal models, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 4 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
NOTE: Consent documents can be signed up to 30 days prior to registration. If \>30 days has elapsed since patient signed the consent document, s/he must re-consent (new signature) before proceeding to register onto study.
* Participants must have sufficient tissue from prior surgery for confirmation of diagnosis and correlative studies. The following amount of tissue is required:
* 15 (5 μm thick) unstained formalin fixed paraffin embedded (FFPE) sections
* 1-2 H\&E stained slides, or additional unstained 5 μm slide(s) for staining
* Protocol treatment plan must include beginning therapy within 5 consecutive days after registration.
Exclusion Criteria:
* Participants may not be receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ponatinib.
* Participants who have received prior treatment with interstitial brachytherapy, stereotactic radiosurgery, or implanted chemotherapy sources, such as wafers of polifeprosan 20 with carmustine
* Participants with poorly controlled diabetes defined as a HgbA1c ≥ 7.0%
* Participants with grade ≥ 3 peripheral motor or sensory neuropathy.
* Participants receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4, including enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days before the first dose of ponatinib will be excluded. This category includes phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, and oxcarbazepine. Lists including medications and substances known or with the potential to interact with CYP3A4 isoenzymes are provided in Appendix B.
--- NOTE: Participants must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period due to potential CYP3A4 interaction.
* Participants taking medications that are known to be associated with Torsades de Pointes or QT prolongation. Refer to Tables C-1 and C-2 of Appendix C for a list of prohibited drugs.
* Participants cannot take any herbal preparations/medications on study or within 7 days prior to first dose of study drug, including but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng.
* Participants who underwent major surgery (including craniotomy) or significant traumatic injury within 28 days prior to initiating therapy. Baseline MRIs for participants who underwent salvage surgery must be obtained at least 4 weeks after procedure and there must be measurable disease.
* Participants who underwent minor surgical procedure within 7 days prior to initiating therapy.
* History of a bleeding disorder.
* Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE Grade \>/= 3 within 30 days prior to study entry.
* Patients whose MRI scan demonstrates intratumoral hemorrhage or peritumoral hemorrhage are not eligible for treatment if deemed significant by the treating physician. If there are questions, the treating physician should contact the study's Overall PI, Dr. Lee
* History of acute pancreatitis within 1 year of study treatment or a history of chronic pancreatitis.
* History of alcohol abuse.
* Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL)
* Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
* Any history of myocardial infarction
* Any history of clinically significant (as determined by the treating physician) atrial arrhythmia
* Any history of ventricular arrhythmia
* Any history of Cerebrovascular accident or transient ischemic attack (TIA)
* Any history of peripheral arterial occlusive disease requiring rvascularization
* Unstable angina within 6 months prior to enrollment
* Congestive heart failure within 6 months prior to enrollment
* Venous thromboembolism including deep venous thrombosis or pulmonary embolism within 6 months prior to enrollment
* Unacceptable Screening Baseline Cardiovascular Assessment:
* Baseline MUGA or Echocardiogram demonstrating LVEF \< 50 %
* QTc \> 480 msec on screening ECG (using the QTcF formula)
* Uncontrolled hypertension (diastolic blood pressure \>90 mm Hg; systolic \>140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
* Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection.
* Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of prior documentation or known history.
* Pregnant or breastfeeding.
-- Pregnant women are excluded from this study because ponatinib has potential for teratogenic or abortifacient effects in animal models. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with ponatinib, breastfeeding should be discontinued if the mother is treated with ponatinib. These potential risks may also apply to other agents used in this study.
* Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs.
* Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
* Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug.
* HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ponatinib. In addition, these individuals 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. | 15,559 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: topotecan hydrochloride, DRUG: vinorelbine tartrate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed lung cancer
* All histologic types eligible
* Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) ≤ 2
* Karnofsky PS ≥ 60%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1.5 mg/dL
* Creatinine ≤ 1.5 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other active invasive malignancy
* No uncontrolled illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* No psychiatric illness/social situation that would limit compliance with study requirements
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy
* No prior therapy with topotecan or vinorelbine ditartrate
* No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
* Recovered from agents administered \> 4 weeks earlier
* No other concurrent investigational agents
* No concurrent palliative radiotherapy
* No other concurrent anticancer therapies or agents
* No concurrent hormones or other chemotherapy except for the following:
* Steroids for adrenal failure
* Hormones for nondisease-related conditions (e.g., insulin for diabetes)
* Intermittent dexamethasone as an antiemetic | 9,291 |
Study Objectives
This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level \[DL\] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: belantamab mafodotin, DRUG: Pembrolizumab
Location: Canada, Germany, United States, Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion criteria:
* Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Male or female, 18 years or older (at the time consent is obtained).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subjects must: have histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by IMWG, 2014 and has undergone stem cell transplant or is considered transplant ineligible, and has been treated with at least 3 prior lines of prior anti-myeloma treatments including an immunomodulatory imide drug (IMiD) (eg. lenalidomide or pomalidomide), a proteasome inhibitor (eg. bortezomib, ixazomib or carfilzomib) and an anti-CD38 antibody alone or in combination. Line of therapy are defined by consensus panel of the International Myeloma Workshop, Has measurable disease defined as one the following: a) Serum M-protein \>=0.5 grams per deciliter (g/dL) (\>=5 grams per liter \[g/L\]). b) Urine M-protein ≥200 mg/24h. c) Serum Free light chain (FLC) assay: Involved FLC level ≥10 milligrams per deciliter (mg/dL) (≥100 milligrams per liter \[mg/L\]) and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
* Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: a) transplant was \> 100 days prior to study enrolment. b) no active infection(s). c) subject meets the remainder of the eligibility criteria.
* Adequate organ system functions as defined by the laboratory assessments.
* All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], version 4.03, 2010) must be \<= Grade 1 at the time of enrolment except for alopecia and Grade 2 neuropathy.
* A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
* Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 140 days after the last dose of study intervention. Male subjects should refrain from donating sperm, plus, either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
Exclusion criteria:
A subject will NOT be eligible for inclusion in this study if any of the following criteria apply:
* Systemic anti-myeloma therapy or an investigational drug \<=14 days or five half-lives, whichever is shorter, preceding the first dose of study drug
* Plasmapheresis within 7 days prior to the first dose of study drug
* Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs
* Has received prior therapy with an anti-PD-1, anti-Programmed cell death Ligand 1 (PD-L1), or anti-Programmed cell death Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event (irAE)
* Current corneal epithelial disease except mild punctate keratopathy
* Any major surgery within the last four weeks prior to the first dose of study therapy
* Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as per adequate organ system function mentioned under inclusion criteria.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
* Has received prior radiotherapy within 2 weeks of start of study therapy. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\<=2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
* History of (non-infectious) pneumonitis that required steroids, or current pneumonitis
* Current active liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Malignancies other than disease under study are excluded, except for any other malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the principal investigators and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (RRMM). Subjects with curatively treated non-melanoma skin cancer are allowed.
* Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study therapy
* Evidence of cardiovascular risk including any of the following: a) corrected for heart rate by Fridericia's formula (QTcF) interval ≥470 msecs. b) Evidence of current clinically significant uncontrolled arrhythmias; i. including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. c) History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening. d) Class III or IV heart failure as defined by the New York Heart Association functional classification system. e) Uncontrolled hypertension. f) Presence of cardiac pacemaker (or defibrillator) with a predominantly ventricular paced rhythm, limiting ECG/QTcF analysis. g) Abnormal cardiac valve morphology (\>=Grade 2) documented by echocardiogram (subjects with grade 1 abnormalities \[i.e., mild regurgitation/stenosis\] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916 or pembrolizumab, or any of the components of the study treatment.
* Pregnant or lactating female.
* Known active infection requiring antibiotic, antiviral, or antifungal treatment.
* Known Human Immunodeficiency Virus (HIV) infection.
* Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment
* Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
* Has received a live-virus vaccination within 30 days of planned start of study therapy.
* Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other chronic form of immunosuppressive therapy within 7 days prior the first dose of study therapy.
* Has known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
* Has had an allogenic tissue/solid organ transplant | 42,058 |
Study Objectives
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.
Conditions: Non-Hodgkin Lymphoma
Intervention / Treatment:
DRUG: Carboplatin, DRUG: Etoposide, BIOLOGICAL: Filgrastim, DRUG: Ifosfamide, PROCEDURE: Leukapheresis, DRUG: Plerixafor, BIOLOGICAL: Rituximab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Diagnosis of CD20+ non-Hodgkin's lymphoma
* Left ventricular ejection fraction at rest \>= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
* Bilirubin =\< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 times the upper limit of normal
* Creatinine clearance (calculated creatinine clearance is permitted) \> 50 mL/min
* Signed informed consent
* Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)
Exclusion Criteria:
* Karnofsky performance score \< 70%
* Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
* Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent \> 5 years previously will be allowed
* Pregnant or breastfeeding
* Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
* Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)
* Human immunodeficiency virus (HIV) positive
* Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
* Hepatitis B carriers | 25,672 |
Study Objectives
CaringBridge (CB) is an online health community for people undergoing challenging health journeys. This platform provides an opportunity for individuals and their caregivers to rally support for a loved-one during a health journey. CaringBridge offers the opportunity for expressive writing through journal entries, wellbeing resources, participant health journey stories, and practical scheduling and communication tools to support community, healing, and wellbeing. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has been shown to increase resilience in the face of adversity. The aim of this study is to better understand how mind-body practices, like LKM, impact adult CB users
Conditions: Cancer, Stress
Intervention / Treatment:
BEHAVIORAL: LovingKindess Meditation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
* English literacy
* CaringBridge user with an active email address
* Visitor/Caregiver/Patient on a Cancer Journey (for Phase 2 only)
Exclusion Criteria:
* N/A | 33,278 |
Study Objectives
This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.
The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.
Sample size: 440 patients
The treatment duration of an individual patient is between 18 and 24 months. Duration of the study for an individual patient including treatment (induction, consolidation \[chemotherapy or allogeneic SCT\], maintenance and follow-up period: Maximum 8 years
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Midostaurin, DRUG: Cytarabine, DRUG: Daunorubicin
Location: Austria, Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients with suspected diagnosis of AML or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) 2008 classification)
* Presence of FLT3-ITD assessed in the central AMLSG reference laboratories
* Patients considered eligible for intensive chemotherapy
* WHO performance status of ≤ 2
* Age ≥ 18 years and ≤ 70 years
* No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤ 7 days)
* Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)
* Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for 5 months after the last dose of chemotherapy
* Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control
* Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy (while on therapy and for 5 months after the last dose of chemotherapy)
* Signed written informed consent.
Exclusion Criteria:
•AML with the following recurrent genetic abnormalities (according to WHO 2008): AML with t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA gene fusions)
* Performance status WHO \>2
* Patients with ejection fraction \< 50% by MUGA or ECHO scan within 14 days of day 1
* Organ insufficiency (creatinine \>1.5x upper normal serum level; bilirubin, AST or ALP \>2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
* Uncontrolled infection
* Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
* Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year
* Known positive for HIV; active HBV, HCV, or Hepatitis A infection
* Bleeding disorder independent of leukemia
* No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation.
* No consent for biobanking. | 34,139 |
Study Objectives
Paronychia is inflammation of the skin surrounding the nail that leads to secondary infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a vehicle control.
Conditions: Chemotherapy-Associated Paronychia
Intervention / Treatment:
DRUG: VBP-926
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Males or females aged 18 years or older
* Acute paronychia developing during the course of their monotherapy or combination chemotherapy
* Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher
* Eastern Cooperative Oncology Group score ≤ 2
* Life expectancy of at least 12 months as per the investigator's judgment
* Willing to provide written informed consent
* Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products
* Individuals who are already on antibiotics as prescribed by oncologist for any condition except paronychia
* Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s)
Exclusion Criteria:
* Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
* Without a history of a cancer diagnosis
* Without history of cancer diagnosis using chemotherapy
* Patients with paronychia requiring surgical intervention at baseline
* Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
* Neutropenia (absolute neutrophil count \< 1500 cells/µL)
* Patient Human Immunodeficiency Virus (HIV) infection
* Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study results
* Have any medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk | 33,203 |
Study Objectives
To keep cancer patients safe, whilst in chemo therapy, patients come into the hospital for multiple blood tests, in order to provide safe antineoplastic treatment and supportive care. Monitoring of relevant blood values (WBC white blood cell count, total and differentiated, ANC absolute neutrophil count, RBC red blood cell count, HGB hemoglobin and PLT platelets) is usually obtained by venipuncture by a health-care professional at the hospital.
HemoScreen is a POCT (point-of-care-technology) automated hematology analyzer that performs complete blood count (CBC) analysis from capillary or venous whole-blood samples. HemoScreen solution has not yet been used by patients to self-test blood cell count, but the investigators hypothesize that cancer patients on systemic anticancer therapy can perform a self-test at home using HemoScreen, and transfer the results to the hospital clinical team, to prevent wasted hospital journeys. This study aims to investigate the feasibility and usability of HemoScreen hematology analyzer for capillary self-testing of blood values in home for cancer patients receiving chemo.
The study consists of a quantitative and a qualitative part. The quantitative part is to compare blood values obtained by capillary self-testing using HemoScreen and venous blood values obtained on standard hospital equipment (Sysmex) in patients. The qualitative part will be observational studies and semi-structured interviews with patients as well as health professionals from the department of Clinical Oncology, as they perform a capillary blood test with HemoScreen themselves. Recruitment of participants will take place at the department of Clinical Oncology in Naestved.
This present study has two phases. The first phase (1) will investigate feasibility, usability and measurement properties of the HemoScreen CBC analyzer, when patients perform a capillary self-test in the outpatient clinic at Oncology supervised by trained personal. Furthermore, Healthcare professionals will test the capillary blood count method. Phase 1 will be conducted to insure that HemoScreen is safely used for capillary self-testing by patient before initiating phase 2, where the HemoScreen is being sent home with the patients for self-measure at home. In Phase 1, 10 cancer patients as well as 4-10 health professionals will be recruited. In phase 2, 33 cancer patients initiating a chemotherapy treatment will be recruited for testing in their home.
Conditions: Cancer
Intervention / Treatment:
DEVICE: HemoScreen hematology analyzer
Location: Denmark
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria patients:
* Breast cancer patients receiving anti-cancer treatment at the Department of Oncology for outpatients
* 18 years old or more
Exclusion Criteria patients:
* Patients unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and results
* Known bleeding disorders
* Bad circulation, if the patient cannot get enough blood drops to do the test
* Inability to give informed content due to mental capacity or language barrier
Inclusion Criteria Health-care professionals:
* Working at the Department of Oncology for outpatients
* 18 years old or more
Exclusion Criteria Health-care professionals:
* If unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
* Known bleeding disorders
* Bad circulation, if the testperson cannot get enough blood drops to do the test
* Inability to give informed content | 3,245 |
Study Objectives
Colon cancer is the third most common cancer in men and women and over 70% of cases are preventable. A western diet, characterized by low vegetable and high red and processed meat intake, indisputably increases colon cancer risk. Heme, which gives red meat its color, is highly reactive, induces hyperproliferation and promotes DNA damage in the colon to a greater degree than any other red meat-associated carcinogen. Preclinical models indicate dietary chlorophyll, which gives green leafy vegetables their color, binds and stabilizes heme in the lumen, preventing genotoxicity. Additionally, data from our randomized controlled weight loss trial indicate increasing red meat consumption has deleterious effects on the gut microbiome, which is also implicated in colon cancer etiology. Because heme-containing foods are the richest sources of bioavailable iron and several other vitamins and minerals, mitigating their potential risks may be more beneficial than eliminating meat, poultry, fish and seafood in their entirety from the diet for risk reduction.
This feasibility study will begin to explore the research question: Will adding chlorophyll-rich green leafy vegetables to the diet prevent the deleterious effects of heme-rich red meat on the human host and microbiome? The investigators will randomly assign 50 adults at increased risk of colorectal adenoma to a block randomized crossover study with two 4-week dietary regimens in which: 1) participants will be provided with frozen green leafy vegetables and counseled to consume a high chlorophyll diet including 1 cup per day of cooked green leafy vegetables and normal meat (high heme) consumption; or 2) continue their normal high heme, low chlorophyll diet (control). A 4-week washout period encouraging habitual diet will be employed between the intervention periods and data will be collected at all four time points.
This study is critical in translating preclinical findings and has the potential to open the door to new knowledge and standards of care in colon cancer prevention. This study is a required step to aid in the design of a larger RCT to determine whether increased green leafy vegetable consumption mitigates the negative effects of red meat on DNA damage, inflammatory cytokines and gut microbe composition. This could lead to equally beneficial dietary guidance for colon health that might be more easily attained by the general public through addition, rather than omission of specific foods.
Conditions: Colon Cancer Prevention
Intervention / Treatment:
BEHAVIORAL: High chlorophyll diet - intervention 1st, BEHAVIORAL: High chlorophyll diet - control 1st
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria:
* Consume less than 2 servings of green leafy vegetables per day
* Consume 5 or more servings of red meat per week
* BMI \>30 kg/m2
* Agrees to not change dietary supplements during course of study
* Willing to comply with dietary regimen over course of study
* Able to store and cook frozen green leafy vegetables (freezer and microwave)
* Able to speak and read English
Exclusion Criteria:
* Previous diagnosis of colon cancer
* Use of any of the following in the past 4 weeks: systemic antibiotics, corticosteroids, immunosuppressive agents, commercial probiotics | 27,720 |
Study Objectives
The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.
Conditions: Bladder Cancer
Intervention / Treatment:
DEVICE: Xpert Bladder Cancer Monitor
Location: Canada, United States, Netherlands
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Subject is ≥ 40 years of age
* Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states.
* Subject is considered disease positive within 12 months (365 days) of enrollment.
* At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort.
* Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled.
Exclusion
* Subject has been previously enrolled into the study.
* Urine specimen to be used for study purposes is from the first morning void.
* Subject has had an excision procedure within six weeks (42 days) of enrollment.
* The subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment. | 8,114 |
Study Objectives
This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: liposomal doxorubicin, DRUG: paclitaxel, DRUG: topotecan
Location: Netherlands, Belgium, Turkey, Germany, Norway, Greece, Spain, Bosnia and Herzegovina, France, Portugal, Denmark, Sweden, Italy, Finland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* female patients, \>/=18 years of age
* epithelial ovarian, fallopian tube or primary peritoneal cancer
* platinum-resistant disease (disease progression within \<6 months of platinum therapy)
* EOCG performance status of 0-2
Exclusion Criteria:
* non-epithelial tumours
* ovarian tumours with low malignant potential
* previous treatment with \>2 chemotherapy regimens
* prior radiotherapy to the pelvis or abdomen | 41,680 |
Study Objectives
Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes. People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have regular checkups to detect changes before they progress to cancer. Every two years patients with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory to check for changes.
Bowel cancer is the third most common cancer in the UK, and the second leading cause of cancer deaths. Prevention and early detection are the most effective strategies of dealing with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are common and have the potential of developing into cancer over the course of many years.
Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular endoscopic examinations known as surveillance endoscopies. This is done to detect changes in the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded videos of Barrett's surveillance examinations and still images of polyps prior to their removal.
Endoscope technology continues to advance. These newly developed technologies are marketed to have claims of superiority in performance over preceding generations often without the back up of scientific data but at a significant financial cost. The aim of this study is to use endoscopic images and videos recorded as part of routine clinical practice to compare the current version of Olympus endoscopes with the new version launched by the company.
Conditions: Barrett Esophagus, Polyps
Intervention / Treatment:
DEVICE: Olympus Elite, DEVICE: Olympus Spectrum
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
* Patients attending for Barrett's surveillance OR
* Patients attending for colonic polyp surveillance or screening
* Patients are willing and able to give informed consent.
Exclusion Criteria:
* Polyp syndromes (eg FAP or Lynch Syndrome)
* Known history of IBD | 959 |
Study Objectives
seeking to identify risk factors leading to mortality in obstructed left cancer colon
Conditions: Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Intervention / Treatment:
PROCEDURE: Resection, PROCEDURE: Stoma
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patient aged above 18 years admitted at Mansoura University Hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma.
Exclusion Criteria:
* Treatment with non-surgical intervention or spontaneous relief of obstruction | 618 |
Study Objectives
RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression (E+ OFS) on brain function may help doctors plan cancer treatment.
PURPOSE: This study is looking at brain function in premenopausal women who are receiving adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical trial IBCSG-2402.
Conditions: Breast Cancer, Fatigue, Sleep Disorders
Intervention / Treatment:
DRUG: Tamoxifen, DRUG: triptorelin, DRUG: Exemestane
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose:
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Completely resected disease
* Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy
* Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:
* Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist
* Ovarian irradiation
* Bilateral oophorectomy
* Hormone receptor status:
* Estrogen and/or progesterone receptor positive
* Each tumor must be hormone receptor positive
PATIENT CHARACTERISTICS:
* Premenopausal
* Can speak and read the local language(s) fluently
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics | 20,784 |
Study Objectives
The goals of this study were to evaluate the efficacy and safety of sequentially blocking the angiogenesis pathway via known antiangiogenic mechanisms, first with bevacizumab and then addition of oral cyclophosphamide upon progression of cancer through bevacizumab. The drugs used in this study were chosen because of their known antiangiogenic properties, tolerability, and anti-ovarian cancer effects.
Conditions: Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: Cyclophosphamide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
* Recurrent cancer and have received and failed a previous platinum-based chemotherapy regimen.
* Up to 2 prior lines of chemotherapy in the recurrent setting (either platinum-based or non-platinum regimens). Biologic therapies count as a prior line but hormonal therapies do not count.
* Platinum-resistant or platinum-sensitive recurrence.
* Must be able to take oral medications and have no evidence of bowel obstruction or partial bowel obstruction
* Measurable disease by either RECIST or Rustin criteria
* No chemotherapy, radiation therapy, nor biologic therapy within the last three weeks prior to initiating therapy
* ECOG score of 0 or 1
* Life expectancy of 12 weeks or greater
* 18 years of age or older
* Laboratory values as outlined in the protocol
* Patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible. Subjects with stage I or II cancer treated with curative intent and no evidence of recurrent disease are also eligible.
* No evidence of preexisting hypertension. If patient has hypertension, it must be controlled medically (less than 150/90) prior to starting bevacizumab
* Normal blood coagulation parameters
* No prior treatment with any other antiangiogenic agents or cyclophosphamide
* For patients who have received prior doxorubicin or pegylated doxorubicin, LVEF must be 50% or greater.
Exclusion Criteria:
* Current, recent (within 4 weeks of the first study infusion), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
* Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years
* Uncontrolled diarrhea
* Prior history of hypertensive crisis or hypertensive encephalopathy
* NYHA Grade II or greater congestive heart failure
* History of myocardial infarction or unstable angina within 6 months prior to Day 1
* History of stroke or transient ischemic attack within 6 months prior to day 1
* Known CNS disease, except for treated brain metastasis
* Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS: Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded.
* Significant vascular disease within 6 months prior to day 1
* History of hemoptysis within 1 month prior to day 1
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
* History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* Proteinuria as demonstrated by a UPC ratio of 1.0 or greater at screening
* Known hypersensitivity to any component of bevacizumab
* Pregnancy (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential | 4,308 |
Study Objectives
What Matters Most is a study that aims to determine how best to help women of lower socioeconomic status make high-quality decisions about early stage breast cancer treatments. What Matters Most will be comparing two decision aids used in the clinic visit to usual care (what normally happens in the clinic). The first decision aid (Option Grid) presents evidence-based information about lumpectomy and mastectomy in a tabular format using text only. The second decision aid (Picture Option Grid) presents evidence-based information about lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most aims to show that the interventions can reduce disparities in decision-making and treatment choice between women of high and low SES.
Conditions: Breast Cancer
Intervention / Treatment:
OTHER: Option Grid, OTHER: Picture Option Grid
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Assigned female at birth;
* 18 years and older;
* Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);
* Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;
* Spoken English, Spanish, or Mandarin Chinese.
Exclusion Criteria:
* Transgender men and women;
* Women who have undergone prophylactic mastectomy;
* Women with visual impairment;
* Women with a diagnosis of severe mental illness or severe dementia;
* Women with inflammatory breast carcinoma. | 25,018 |
Study Objectives
The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.
Conditions: Salivary Gland Tumors, Head and Neck Cancer
Intervention / Treatment:
DRUG: Docetaxel, RADIATION: Intensity-modulated radiotherapy, DRUG: Pemetrexed, DRUG: Cisplatin
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
4. No evidence of distant metastases
5. No synchronous or concurrent head and neck primary tumors
6. Karnofsky score over 60
7. Adequate organ function including the following:
1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
2. Platelets count \>= 100 \* 10\^9/l
3. Hemoglobin \>= 10 g/dl
4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
5. Total bilirubin \<= 1.5 times institutional ULN
6. Creatinine clearance \>= 50 ml/min
7. Serum creatine \<= 1 times ULN
8. Signed written informed consent
Exclusion Criteria:
1. Evidence of distant metastasis
2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia | 15,315 |
Study Objectives
An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.
Conditions: Colon Neoplasm, Colon Adenocarcinoma, Colon Cancer, Colo-rectal Cancer, Rectal Cancer, Rectal Neoplasms, Rectal Adenocarcinoma, Rectal Tumors, Pancreatic Cancer, Pancreas Cancer, Pancreatic Neoplasms, Pancreatic Adenocarcinoma
Intervention / Treatment:
Location: Pakistan
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Informed consent is obtained from the participant
* Patients with pancreas or colorectal carcinoma undergoing surgery
* The participant is older than 18 years old
Exclusion Criteria:
* Inability to provide informed consent
* The patient is not suffering from pancreas or colo-rectal carcinoma
* Patient has a condition contradicting surgery
* The participant is younger than 18 years old
* Previously enrolled in the study | 16,341 |
Study Objectives
This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.
Conditions: Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: docetaxel (Taxotere®), DRUG: ZD1839
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must be greater than or equal to 70 years of age.
* Patients must have histologically confirmed non-small cell lung cancer (NSCLC) that is Stage IIIb (with pleural effusions) or Stage IV.
* Patients must be previously untreated for metastatic disease but may have received previous adjuvant chemotherapy more than six months prior to registration. Patients may also have received radiation therapy for advanced disease; however there should be measurable disease outside the radiation ports.
* Disease must be at least unidimensionally measurable. Lesions, which are located within a previously irradiated field, are not considered measurable unless there is a documented growth in its size.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Laboratory values must be as follows: White blood cell count greater than or equal to 3,000/mm\^3; Absolute neutrophil count greater than or equal to 1,500/mm\^3; Platelets greater than or equal to 100,000/mm\^3; Total bilirubin less than or equal to 1.0 x institutional upper normal limit; Serum creatinine less than or equal to 2 x institutional upper normal limit; aspartic transaminase (AST) or ALANINE TRANSAMINASE (ALT) less than or equal to 1.5 x institutional upper normal limit; Alkaline Phosphatase less than or equal to 1.5 x institutional upper normal limit; Serum calcium less than or equal to 1.5 x institutional upper normal limit (corrected for serum albumin).
* Patients with combined alkaline phosphatase, AST and/or ALT elevations will not be allowed to enroll on protocol.
* Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia.
* In keeping with the policies of the institution, patients must sign an informed consent form indicating that they are aware of the investigational nature of this study
* Patients with stable brain metastases after completion of radiation will be allowed to enroll in this trial.
* Patients treated with adjuvant therapy more than six months ago will be allowed to enroll in this trial.
* Cognitively impaired patients will be allowed to enroll on the trial if the legal guardian signs the consent form after a full informed consent process is completed. Whenever feasible the cognitively impaired person will also give assent to participation in the trial.
Exclusion Criteria:
* Patients previously treated with chemotherapy or ZD1839.
* Patients with known or clinical evidence of active central nervous system (CNS) metastasis. Patients with stable, previously treated brain metastases will be allowed.
* Male Patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
* Patients with concurrent serious infections (i.e., receiving an intravenous antibiotic) are not eligible.
* Patients with an unstable or serious concurrent medical condition are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, grade 3 neuropathies, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
* Patients receiving other non-approved or investigational therapy concurrently or within 30 days of Day 1 of trial treatment.
* Patients with a history of other cancers except basal cell skin cancers, carcinoma of the cervix in situ, or curatively-treated cancers with \> 2 years non-recurrence prior to entry in the trial. Patients with a history of other cancers must have histological confirmation that current disease is compatible with diagnosis of NSCLC.
* Peripheral neuropathy \>2. (Peripheral neuropathy must be \< grade 1)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Docetaxel, ZD 1839, Polysorbate 80, or other agents used in the study.
* Patients with combined alkaline phosphatase, AST and/or ALT elevations will be excluded from this protocol.
* Patients previously treated with radiation therapy. | 21,366 |
Study Objectives
The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer.
* If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer.
* If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.
* If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.
Conditions: Cancer, Carcinoma, Non-Small Cell Lung
Intervention / Treatment:
DRUG: Sorafenib (Nexavar, BAY43-9006)
Location: Germany, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Age = 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Life expectancy of at least 12 weeks at the pre-treatment evaluation
* Patients with metastatic, measurable, histologically or cytologically documented NSCLC (includes squamous, large cell or adenocarcinoma). In case of unique metastatic site, histological confirmation is required in order to ensure proper diagnosis prior to study entry
* Patients must have progressive non-small cell lung cancer (NSCLC)
* No more than 2 prior systemic agent or regimen at least 28 days prior to study entry. (Prior therapy with gefitinib is allowed but not mandatory)
* Patients must be considered appropriate for systemic anti-cancer therapy by the Investigator
* Patients with at least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Adequate bone marrow, liver and renal function, as assessed by the following laboratory:
* Hemoglobin = 9.0 g/dl
* Absolute granulocytes = 1.5 x 10E9/L
* Platelet count = 100 x 10E9/L
* Total bilirubin \< 1.5 x the upper limit of normal
* alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (\< 5 x upper limit of normal for patients with liver involvement of their cancer)
* prothrombin time (PT) or International Normalized Ratio (INR) and partial thromboplastin time (PTT) \< 1.5 x upper limit of normal (except in patients who are on warfarin or heparin. Patients who receive anti-coagulation treatment with an agent such as warfarin or heparin, prophylactically or therapeutically, will be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care)
* Serum creatinine = 2.0 x upper limit of normal
* Amylase and lipase \< 1.5 x the upper limit of normal
Exclusion Criteria:
* Cardiac arrhythmia requiring anti-arrhythmics (excluding beta-blockers or digoxin), symptomatic coronary artery disease (CAD) or ischemia (myocardial infarction (MI) within the last 6 months) or congestive heart failure (CHF) \> New York Heart Association (NYHA) Class II
* Uncontrolled hypertension
* Complete renal shut-down requiring hemo- or peritoneal dialysis
* Mixed histologies
* Active clinically serious infections (\> grade 2 on the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0)
* Known history of HIV infection or chronic hepatitis B or C
* Known metastatic brain or meningeal tumors, unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. A head CT or MRI must be conducted to rule out brain metastasis or meningeal tumors. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided that the dose is stable for one month prior to and following screening radiographic studies)
* History of seizure disorder requiring medication (such as steroids or anti-epileptics)
* History of organ allograft and bone marrow transplant
* Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis \& T1\] or other malignancies curatively treated \> 3 years prior to entry)
* Patients with clinically significant bleeding (e.g., gastrointestinal bleeding) within the past month prior to study entry are ineligible
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures (e.g. cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between BAY 43-9006 and oral contraceptives
* Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patients participation in the study or evaluation of the study results
* Known allergy to the investigational agent or any agent given in association with this trial
* Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment
* Anti cancer chemotherapy, immunotherapy, vaccines or investigational therapy during the study or within 4 weeks of study entry.
* Radiotherapy during the study or within 4 weeks of study entry. Patients must have recovered from radiation-induced toxicity. However, palliative is allowed for local pain control.
* Any surgical procedure within 4 weeks prior to the start of study drug. Autologous and/or allogenic including mini-allogenic bone marrow transplant or stem cell rescue. Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF) or Granulocyte macrophage colony-stimulating factor (GM-CSF), during or within 3 weeks of study entry. G-CSF and other hematopoietic growth factors may only be used in the management of acute toxicity, when medically indicated, or at the discretion of the investigator. Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study. Use of St. John's Wort. Use of rifampicin. Prior use of Raf-Kinase inhibitors, MAPK/ERK kinase (MEK) or Farnesyl Transferase Inhibitors. Prior use of Bevacizumab and all other drugs that target vascular endothelial growth factor (VEGF)/ vascular endothelial growth factor receptor (VEGFR). Use of any investigational drug therapy outside of this during or within 4 weeks of study entry. | 31,011 |
Study Objectives
This is a Phase 1, open label study to assess the safety and tolerability of U3 1565, determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety and tolerability.
Conditions: Advanced Solid Malignant Tumors, Advanced Ovarian Cancer
Intervention / Treatment:
DRUG: U3-1565
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Pathologically documented advanced solid malignant tumor refractory to standard treatment or for which no standard treatment is available.
* Evaluable tumor for all parts of the study and, only for enrollment in Part 2b, measurable tumor per RECIST version 1.1. However, subjects with advanced ovarian cancer may be enrolled in Part 2b even if they do not have a tumor measurable per RECIST version 1.1, as long as they have circulating levels of CA125 higher than 35 U/mL.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1.
* Men or women \>= 18 years of age.
* Willing to provide pre-existing diagnostic or resected tumor samples, such as paraffin embedded sections, if available.
* Willing, only for enrollment in Part 2b, to provide tumor biopsies before and after treatment.
* For female subjects, is postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile or, if otherwise of childbearing potential, has a negative urine or serum pregnancy test at entry into the study, uses maximally effective birth control during the course of the study, and is willing to use contraception for 6 months following the last study drug administration.
* For male subjects, is surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last study drug administration.
* Able to comprehend, sign, and date current Institutional Review Board- (IRB) approved informed consent form (ICF - including Health Insurance Portability and Accountability Act \[HIPAA\] authorization, if applicable) before performance of any study-specific procedures or tests.
Exclusion Criteria:
* History of lymphoma, leukemia, or other hematopoietic malignancy.
* History of human immunodeficiency virus (HIV) positivity. HIV testing is not required for establishing eligibility.
* History of bleeding diathesis.
* History of idiosyncratic reactions to antibody drug products.
* History of stem cell or bone marrow transplant.
* History of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF; New York Heart Association \> Class II), unstable angina or unstable cardiac arrhythmia requiring medication
* History of clinically significant pulmonary disease after receiving epidermal growth factor receptor- (EGFR) targeting agents.
* Any concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
* Clinically active brain metastases defined as symptomatic or requiring treatment with steroids or anti-convulsants.
* Unresolved toxicities from prior anti-cancer therapy defined as toxicities, except alopecia, not yet resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade =\< 1 or baseline values. Subjects with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator or Sponsor (eg, Grade 2 chemotherapy-induced neuropathy).
* Mean QTcF (Fridericia's correction) intervals \> 450 msec for male subjects and \> 470 msec for female subjects, based on screening electrocardiogram (ECG).
* Moderate to severe cardiac valvular abnormalities identified by echocardiography at screening.
* Hematological values, as follows:
Absolute neutrophil count (ANC) \< 1.5 X 109/L Platelet count \< 100 X 109/L Hemoglobin (Hb) \< 9 g/dL - Renal function, as follows: Creatinine \> 1.5 X upper limit of normal (ULN) or creatinine clearance \< 60 mL/min, as calculated using the modified Cockcroft Gault equation.
- Hepatic function, as follows: Aspartate aminotransferase (AST) \> 3 X ULN (if liver metastases are present, \> 5 X ULN).
Alanine aminotransferase (ALT) \> 3 X ULN (if liver metastases are present, \>= 5 X ULN)
* Bilirubin \> 1.5 X ULN
* Coagulation function, as follows:
Prothrombin time (PT) or partial thromboplastin time (PTT) \> 1.5 X ULN
* Anti-cancer therapy, including antibody, retinoid, or hormonal treatment, within 3 weeks before enrollment. Prior and concurrent use of hormone replacement therapy, use of gonadotropin-releasing hormone modulators for prostate cancer, and use of somatostatin analogs for neuroendocrine tumors are permitted.
* Therapeutic radiation treatment within 4 weeks or palliative radiation treatment within 2 weeks before enrollment, as long as radiation toxicities have resolved to NCI CTCAE grade =\< 1 or baseline values.
* Major surgery within 4 weeks before enrollment. | 41,944 |
Study Objectives
The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Gemtuzumab Ozogamicin
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
* Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
* Phase II will only allow enrollment of younger de novo AML
Exclusion Criteria:
* AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
* De novo patients with M3 AML
* AML secondary to exposure to chemotherapy or radiation | 40,967 |
Study Objectives
Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.
Conditions: Microinvasive Squamous Cell Carcinoma
Intervention / Treatment:
DRUG: lidocaine-prilocaine 5% cream application, DEVICE: 2940-nm Er:YAG AFL pretreatment, DRUG: methyl-aminolevulinate application, DEVICE: Illuminating using red light-emitting diode lamps
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: DOUBLE | Inclusion Criteria:
* Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions:
* tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and
* difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems)
Exclusion Criteria:
* pregnancy or lactation
* active systemic infectious disease
* other inflammatory, infectious, or neoplastic skin diseases in the treated area
* allergy to MAL,other topical photosensitizers, or excipients of the cream
* history of photosensitivity
* use of immunosuppressive or photosensitizing drugs
* participation in any other investigational study in the preceding 30 days
* history or indicators of poor compliance
* Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria | 33,392 |
Study Objectives
Although there is evidence for reducing complication rate and improving recovery after the implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery, most published papers include patients undergoing open resections. The aim was to analyse factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal surgery for cancer combined with ERAS protocol.
Conditions: Colonic Neoplasms, Laparoscopy, Perioperative Care
Intervention / Treatment:
Location: Poland
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* colorectal cancer
* laparoscopic resection
* perioperative care according to ERAS principles
Exclusion Criteria:
* Patients submitted initially for open or emergency surgery
* with complex cancer who required multi-organ resection
* patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision) | 24,449 |
Study Objectives
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: Vandetanib
Location: Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
* ECOG performance status \<1
* Measurable disease
Exclusion Criteria:
* Severe or uncontrolled systemic disease
* Clinically significant cardiac event such as myocardial infarction
* Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes | 43,650 |
Study Objectives
The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine and cisplatin in patients with non-small cell lung cancer.
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: LY293111, DRUG: cisplatin
Location: Netherlands, Germany, United States, Israel, Canada, Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Non-Small Cell Lung Cancer, Stage IIIB or IV that is not amenable to either surgery of curative intent or radiation therapy
* Tumor that can be measured by x-ray or scan
* Adequate organ function
Exclusion Criteria:
* Inability to swallow capsules
* Documented brain metastases
* Prior chemotherapy or biological therapy for this disease | 34,297 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma.
Conditions: Brain and Central Nervous System Tumors
Intervention / Treatment:
DRUG: karenitecin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme
* Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy
* Prior low-grade disease that progressed to high-grade after therapy allowed
* Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 8.5 g/dL
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 4 times upper limit of normal
Renal:
* Creatinine no greater than 1.7 mg/dL
Other:
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
* No serious concurrent infection
* No other medical illness that would preclude study
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No more than 1 prior chemotherapy regimen
Endocrine therapy:
* Must be on stable dose of steroids for at least 5 days
Radiotherapy:
* See Disease Characteristics
* At least 3 months since prior radiotherapy and recovered
* No more than 1 prior course of radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent investigational agents
* At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes | 15,639 |
Study Objectives
This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP).
Purpose: The LAP-01 trial compares outcomes between RARP and LRP.
Conditions: Prostate Cancer
Intervention / Treatment:
PROCEDURE: Prostatectomy
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion criteria
* Histological verified prostate carcinoma (first diagnosis)
* Indication for primary curative radical prostatectomy
* Age ≤ 75 years
* Patient agrees to randomisation
* Patient is able to fill in the questionnaires on his own
* Patient is willing to provide written informed consent
Exclusion Criteria:
* Insufficient knowledge of German
* Severe cognitive impairment
* Obesity (BMI \> 35)
* Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind)
* Tumor stage: T4
* Previous malignancy (≤ 3 years before trial participation)
* Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial
* Patient is immuno-compromised
* History of intermittent urinary self-catheterization within the last year
* Psychological disorders (dementia, chronic depression, psychosis)
* Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy
* Patients with chronic urinary infection
* Dialysis patients
* Lacking willingness for data storage and handling in the frame of the trial protocol/aims | 11,457 |
Study Objectives
This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Stage IV Non-small Cell Lung Cancer (NSCLC), Recurrent Non-small Cell Lung Cancer (NSCLC), Extensive-stage Small Cell Lung Cancer (SCLC), Recurrent Small Cell Lung Cancer (SCLC), Tumors Metastatic to Brain, Metastatic Breast Cancer (mBC)
Intervention / Treatment:
DRUG: Pegylated Irinotecan
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* At least 18 years of age.
* Life expectancy of 3 months or longer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Advanced or refractory cancer, consisting of
* Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is indicated. OR
* Histologically-proven metastatic lung cancer:
* Non-small cell lung cancer (NSCLC) as Stage IV disease or recurrent metastatic disease \[per lung cancer tumor, node and metastasis (TNM) classification system, 7th ed\] (Cohort A) OR
* Small cell lung cancer (SCLC) as extensive stage or recurrent metastatic disease (cohort B), including tumors with mixed small cell and non-small cell elements.
Prior chemotherapy (at least one of the following):
* At least one line of prior systemic chemotherapy
* At least one line of prior targeted treatment for metastatic disease Adjuvant systemic chemotherapy within prior 6 months Prior treatment for metastatic breast cancer (mBC) must have included taxane-based regimen
Prior chemotherapy, including other investigational therapy, has been completed prior to initiation of study treatment, according to the following:
* ≥ 2 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered on a daily or weekly schedule
* ≥ 3 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 2 weeks
* ≥ 4 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 3 weeks Previously received at least one CNS directed treatment (such as surgery or radiation) OR not be eligible for CNS stereotactic radiosurgery Measurable CNS disease, either previously untreated (not counting systemic therapy), or progressed following previous radiation treatment. Lesions that have progressed after prior radiosurgery should not be selected as measurable disease if they are suspected of being radionecrosis.
The following measurement criteria are required, as visualized by contrast-enhanced MRI with slice thickness of ≤ 1.5 mm, unless absence of contrast or thicker slices is specifically authorized by Protocol Director. Measurements do not include tumor edema.
* At least one CNS tumor measuring ≥ 10 mm in longest diameter, OR
* At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm. Additional tumors are not exclusionary.
Adequate organ function as evidenced by:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L without G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days
* Hemoglobin (Hgb) ≥ 9.0 g/dL (90 g/L) without blood transfusion within 7 days
* Platelet count ≥ 100 x 10e9/L without platelet transfusion within 7 days
* Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert's disease who may have DIRECT bilirubin ≤ 1.5 X ULN
* Alanine aminotransferase (ALT) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
* Aspartate aminotransferase (AST) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
* Serum creatinine ≤ 1.5 X ULN; or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula), or measured creatinine clearance ≥ 50 mL/min.
Exclusion Criteria:
* Previous treatment with a camptothecin derivative (eg, irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecin, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed
* Patients may not have a known history of leptomeningeal disease, as diagnosed by positive CSF cytology, unless prospective permission for enrollment is granted from the sponsor and the PI
* Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period
* Patients may not have the following co morbid disease or concurrent illness:
* Chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients may not use chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to first dose of investigational drug. (exception: anti-diarrheal medications used to control symptoms from a medication that will be discontinued prior to study are allowed with a 7 day washout before study therapy, for example loperamide for erlotinib-associated diarrhea)
* Known cirrhosis, defined as Child Pugh class A or higher liver disease
* Other active malignancy, except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder)
* Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation
* Patients may not have a known allergy or hypersensitivity to any of the components of the investigational therapy, including polyethylene glycol (PEG) or topoisomerase inhibitors
* Patients may not be receiving the following medications at the time of first dose of investigational drug:
* Pharmacotherapy for known hepatitis B or C, tuberculosis, or human immunodeficiency virus (HIV)
* Any of the following enzyme inducing anti epileptic medications (EIAEDs): phenytoin, carbamazepine, oxcarbazepine, phenobarbital
* Other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except for bisphosphonates or denosumab
* Pregnant or nursing patients will be excluded from the study | 27,449 |
Study Objectives
A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives.
Conditions: Colorectal Cancer
Intervention / Treatment:
OTHER: Financial Incentive
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Between 50 to 75 years old
* Has had at least two visits at Penn Family Care Within the past two years - Due for screening
* Asymptomatic for colorectal cancer (CRC)
* Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
* Have a primary care provider in Penn Family Care
Exclusion Criteria:
* Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
* Has a history of CRC
* Has a history of other GI cancer
* Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
* Has history of colitis other than Crohn's disease or ulcerative colitis
* Has had a colectomy
* Has a relative that has been diagnosed with CRC
* Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
* Has been diagnosed with Familial Adenomatous Polyposis (FAP)
* Has anemia (iron-deficient or general/unspecified)
* Has history of lower GI bleeding
* Has metastatic (Stage IV) blood or solid tumor cancer
* Has end stage renal disease
* Has had congestive heart failure
* Has dementia
* Has cirrhosis or end stage liver disease
* Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study | 13,328 |
Study Objectives
Objectives:
To determine maximum tolerated dose of farnesyl transferase inhibitor, SCH 66336, when administered w TEMODAR®.
To characterize any toxicity associated w combo of farnesyl transferase inhibitor, SCH 66336, \& TEMODAR®.
To observe patients for clinical antitumor response when treated with combination of farnesyl transferase inhibitor, SCH 66336, \& TEMODAR®.
To assess pharmacokinetics of SCH 66336 for patients on \& not on enzyme inducing antiepileptic drugs.
Conditions: Gliosarcoma, Glioblastoma, Anaplastic Astrocytoma
Intervention / Treatment:
DRUG: Temodar and SCH 66336
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Pts with MG histologically confirmed at diagnosis, who were treated previously with conventional external beam radiation \& with or without chemotherapy, \& have stable disease, recurrence or relapse at the time of enrollment.
* Age \> or = to 18 years.
* Patients who have had previous surgical resection(s) are eligible.
* Interval of at least 3 weeks between prior surgical resection, 2 weeks between prior radiotherapy, or 4 weeks between prior chemotherapy, unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy.
* Karnofsky performance score \> or = to 60%.
* Adequate hematologic, renal \& liver function as demonstrated by lab values performed within 14 days, inclusive, prior to administration of chemotherapy:
* ANC \> or = to 1500/mm3
* Platelet count \> or = to 100,000/mm3
* Hemoglobin \> or = to 10 gm/dL
* BUN and serum creatinine \<1.5 times upper limit of lab normal
* Total serum bilirubin \<1.5 times upper limit of lab normal
* SGOT \<2.5 times upper limit of lab normal
* Patients must have recovered from any effects of major surgery.
* Patients must have life expectancy of greater than 12 weeks.
* Patients or legal guardian must give written, informed consent.
Exclusion Criteria:
* Patients requiring immediate radiation therapy.
* Patients who have not recovered from surgery.
* Patients who are not neurologically stable for 2 weeks prior to study entry.
* Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
* Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction).
* Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
* Known HIV positivity or AIDS-related illness.
* Pregnant or nursing women.
* Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
* Men who are not advised to use an effective method of contraception.
* Patients taking immuno-suppressive agents other than prescribed corticosteroids.
* Patients previously treated with farnesyl transferase inhibitors.
* Patients with significant QTc prolongation (\>500 msec)as evaluated by an EKG.
* Patients having presented prior disease progression on TEMODAR.
* Patients having presented any grade 4 hematologic toxicity or grade 3 or 4 non-hematologic toxicity on TEMODAR in the past. | 28,347 |
Study Objectives
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Conditions: Cancer
Intervention / Treatment:
DRUG: CYC065
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* 18 years or older
* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* Evaluable disease
* Adequate organ functions
* 4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
* At least 4 weeks from major surgery
* Agree to practice effective contraception
* Agree to follow protocol required evaluations
* Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
* Previously untreated CNS metastasis or progressive CNS metastasis
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating women
* Known to be HIV-positive
* Known active hepatitis B and/or hepatitis C infection | 38,156 |
Study Objectives
The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.
Conditions: Breast Cancer
Intervention / Treatment:
BIOLOGICAL: Nivolumab, BIOLOGICAL: Ipilimumab, DRUG: Nab-paclitaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Histological and cytological confirmation of adenocarcinoma of the breast
* Documented HER2 negative and estrogen receptor (ER) positive status of primary or metastatic tumor tissue using the most recently assessed tumor specimen, according to the local laboratory parameters
* ER negativity is defined as \< 1% of tumor cells expressing hormonal receptors via IHC analysis
* At least one measurable lesion, as per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT) or magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Women and Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Exclusion Criteria:
* Allergy or hypersensitivity to any study drugs or their excipients
* Any other sound medical, psychiatric and/or social reason as determined by the investigator
* Active, known, or suspected autoimmune disease or immune-related diseases
* History of unstable or deteriorating cardiac disease within the previous 12 months prior to screening
* Prior therapy with anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) or anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) class antibody
* Any major surgery within 4 weeks of the first dose of study treatment
Other protocol-defined inclusion/exclusion criteria apply | 3,337 |
Study Objectives
Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.
Conditions: Breast Cancer, Genitourinary Syndrome of Menopause
Intervention / Treatment:
DEVICE: Fractional/Pixel CO2 laser
Location: Israel
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: DOUBLE | Inclusion criteria:
1. Patients diagnosed with breast cancer
2. Menopause: spontaneous, surgical or chemotherapy induced
3. One or more GSM Symptoms: dryness, irritation, burning, pain, dyspareunia, dysuria
4. On exam, clinical findings of atrophy: thin, dry, pale vagina
5. Age\>18
6. Normal Pap smear within 3 years
Exclusion criteria:
1. Menstruation
2. Chemotherapy
3. Vaginal bleeding which did not underwent evaluation
4. Concurrent treatment with topical estrogen
5. Previous vulvar, vaginal or cervical dysplasia\\ cancer | 34,856 |
Study Objectives
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Azacitidine, DRUG: Conventional Care Regimen
Location: Taiwan, Korea, Republic of, Netherlands, Belgium, Austria, Germany, United States, Poland, China, Israel, Canada, Australia, Spain, France, United Kingdom, Czechia, Russian Federation, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Diagnosis of one of the following
* Newly diagnosed de novo acute myeloid leukemia (AML)
* AML secondary to myelodysplastic syndromes (MDS)
* AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
* Bone marrow blasts \>30%
* Age ≥ 65 years
* Easter Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria:
* Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
* Previous treatment with azacitidine, decitabine or cytarabine
* Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
* AML French American British subtype (FAB M3)
* AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
* Prior bone marrow or stem cell transplantation
* Candidate for allogeneic bone marrow or stem cell transplant
* Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
* Malignant hepatic tumors
* Uncontrolled systemic infection
* Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
* Use of any experimental drug or therapy within 28 days prior to Day 1 | 39,968 |
Study Objectives
Recent studies have shown that survival after a colorectal cancer diagnosis may be affected by a person's activity level and body size. This research says that for colorectal cancer patients, the less active and more obese they are, the more likely they are to have a cancer recurrence or die from their cancer. Chemotherapy has been shown to reduce activity levels, fitness, and body size in some cancer patients. However, it is not known how chemotherapy specific for colon cancer patients affects their activity levels, fitness, and body size. The main goal of our study will be to look at how chemotherapy treatments affect the fitness, activity levels, and body size in colon cancer patients. In order to do this, we will measure these variables before chemotherapy treatments, and at 1 and 6 months following the end of treatment. Our results will show how chemotherapy affects fitness, activity levels, and body size in colon cancer patients and provide data to help in designing an exercise intervention specifically for colon cancer survivors.
Conditions: Colonic Neoplasms
Intervention / Treatment:
Location: Canada
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* histologically confirmed colon cancer (Stage III and those Stage II patients deemed high-risk
* approval of the treating oncologist
* scheduled to received chemotherapy
* able to understand and provide written informed consent in English
* 18+ years of age
* no uncontrolled co-morbidities (including hypertension, cardiac illness, psychiatric condition, etc.)
* negative ECG as assessed during maximal graded exercise test
Exclusion Criteria:
* metastatic or recurrent colon cancer patients
* pregnancy
* any uncontrolled medical condition that would be a contraindication to exercise (assessed by treating oncologist)
* unwilling to attend, travel to or participate in the assessments at all 3 time points
In addition, 10 patients meeting all of the eligibility criteria who are not scheduled to receive chemotherapy will also be recruited to the study to serve as "surgery only" controls. | 4,771 |
Study Objectives
The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.
Conditions: Sarcoma
Intervention / Treatment:
DRUG: Ridaforolimus
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
* Adequate organ and bone marrow function
Exclusion Criteria:
* Presence of brain or central nervous system (CNS) metastases, unless successfully treated
* Prior therapy with rapamycin or rapamycin analogs
* Ongoing toxicity associated with prior anticancer therapy
* History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient | 22,702 |
Study Objectives
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: Treosulfan, DRUG: Treosulfan
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* patient with relapsed ovarian cancer
* study therapy of third regime
* measurable or evaluable tumor lesions or progression defined as CA-125 more than \>= 100 U/ ml.
* Age \>= 70 years
* ECOG 0-2
* written informed consent
Exclusion Criteria:
* Pretreatment with treosulfan
* patient without measurable or evaluable tumor lesions or CA-125 more than \>= 100 U/ ml.
* no adequate bone marrow function (leukocyte \<= 2,9 x 109/l, platelets \<= 100 x 109/ l
* creatinin and bilirubin within \>= 1,25 x fold of the reference laboratory´s normal range
* simultaneous radiotherapy | 6,399 |
Study Objectives
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of biological therapy plus chemotherapy in treating patients with metastatic or recurrent kidney cancer.
Conditions: Kidney Cancer
Intervention / Treatment:
BIOLOGICAL: aldesleukin, BIOLOGICAL: recombinant interferon alfa, DRUG: fluorouracil, DRUG: isotretinoin, PROCEDURE: surgical procedure
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically proven metastatic and/or recurrent renal cell carcinoma Bidimensionally measurable disease No concurrent brain metastases Patients with prior brain metastases who have undergone radiation and/or surgery, with stable response, confirmed by MRI, and off corticosteroids are eligible
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious illness or active infection requiring antibiotics Not HIV positive No active substance abuse
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior interleukin-2 therapy At least 6 months since prior interferon alfa therapy At least 1 month since other prior biologic therapy No other concurrent biologic therapy (e.g., filgrastim or sargramostim) Chemotherapy: At least 6 months since prior fluorouracil therapy At least 1 month since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 1 month since prior endocrine therapy No concurrent hormone therapy No concurrent corticosteroids except if inhaled or topical Radiotherapy: At least 1 month since prior radiotherapy (to less than 25% of the bone marrow only, and there must be measurable disease outside of radiation field) No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery Other: No concurrent ongoing therapy with investigational drugs | 36,551 |
Study Objectives
RATIONALE: 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma.
PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.
Conditions: Lymphoma
Intervention / Treatment:
BIOLOGICAL: Rituximab, BIOLOGICAL: Sargramostim (GM-CSF)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Patients must have histologically confirmed newly diagnosed follicular B-cell lymphoma.
2. Patients must have measurable disease, defined as at least one lesion 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.
3. Patients should not have received prior therapy of any kind for follicular B-cell lymphoma.
4. Age \>/= 18 years. Because no dosing or adverse event data are currently available for the use of rituximab in combination with sargramostim in patients (males or females) \<18 years of age, children are excluded from this study.
5. Eastern Cooperative Oncology (ECOG) performance status \</= 2 (Karnofsky \>/= 60%).
6. Patients must have normal organ and marrow function as defined below: - leukocytes \>/= 3,000/microL; - absolute neutrophil count \>/= 1,500/microL; - platelets \>/= 100,000/microL; -total bilirubin within normal institutional limits; - AST(SGOT)/ALT(SGPT) \</= 2.5 X institutional upper limit of normal; - creatinine within normal institutional limits OR - creatinine clearance \>/= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
7. Hemoglobin \>/= 8.0 gm/dL
8. The effects of rituximab and sargramostim on the developing human fetus at the recommended therapeutic doses are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
9. Ability to understand and the willingness to sign an informed consent document.
Exclusion Criteria:
1. Prior therapy of any kind for follicular B-cell lymphoma.
2. Patients may not be receiving any other investigational agents.
3. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab or other agents used in the study.
5. Rituximab is contraindicated in patients with known anaphylaxis or IgE-mediated hypersensitivity to murine proteins. Sargramostim is contraindicated in patients with excessive leukemic myeloid blasts, with known hypersensitivity to GM-CSF or yeast-derived components of the recombinant, and for concomitant (or within 24 hours ± of) uses with chemotherapy or radiotherapy.
6. 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.
7. Pregnant women are excluded from this study.
8. Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions.
9. Patients with evidence of active or prior infection of Hepatitis B are excluded. (Note: Persons vaccinated for Hepatitis B who have positive antibodies are not excluded). | 26,003 |
Study Objectives
Background:
* Combined therapy with rituximab and fludarabine is the treatment of choice for advanced stage chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
* A new technology called deoxyribonucleic acid (DNA) microarray can be used to gain knowledge about the genetic basis of CLL/SLL.
* Genetic studies of CLL/SLL may improve our understanding of what happens in the disease, help determine which patients are most likely to respond to treatment with fludarabine and rituximab, and identify new treatments.
Objectives:
-To gain further knowledge about CLL/SLL and the role of rituximab and fludarabine in treating the disease.
Eligibility:
-Patients 18 years of age and older with low, intermediate or high-risk CLL/SLL.
Design:
* Patients with low-risk CLL/SLL do not receive treatment, but are followed every 3 to 6 months and donate cells (through apheresis) or lymph nodes, or both, for research purposes.
* Patients with intermediate or high-risk CLL/SLL receive standard treatment with rituximab and fludarabine for six 28-day treatment cycles. Rituximab is given on day 1 and fludarabine is given on days 1-5. (For the first cycle only, fludarabine treatment starts on day 2. This delay permits blood sampling on day 1 for the effect of rituximab on white blood cells.)
* Laboratory tests and imaging studies are done periodically to monitor drug side effects and the response to treatment. Tests include bone marrow biopsy and aspiration, blood tests and x-rays, including positron emission tomography (PET) and computed tomography (CT) scans.
Conditions: Chronic Lymphocytic Leukemia
Intervention / Treatment:
BIOLOGICAL: Rituximab, DRUG: Fludarabine phosphate, OTHER: Leukemic or stroma cells
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | * INCLUSION CRITERIA:
Diagnosis of chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) will be made according to the World Health Organization (WHO) diagnostic classification. A lymphocyte count in excess of 5000/mcl is typically found in the leukemic variant but is not a pre-requisite for a diagnosis of SLL. Low, Intermediate or High-Risk Category of CLL/SLL, using the Modified Three-Stage Rai Staging System as follows:
Risk Category: Low Risk
Rai Stage: 0
Clinical Features: Elevated blood and marrow lymphocyte numbers only (L). (lymphocytes greater than 5000/microl in blood, and lymphocytes greater than 30 percent in marrow).
Risk Category: Intermediate Risk
Rai Stage: I
Clinical Features: L + enlarged lymph nodes (LN)
Risk Category: Intermediate Risk
Rai Stage: II
Clinical Features: L + enlarged spleen or liver
Risk Category: High Risk
Rai Stage: III
Clinical Features: L + anemia (Hemoglobin less than 11 gm/dl)
Risk Category: High Risk
Rai Stage: IV
Clinical Features: L + thrombocytopenia (platelets less than 100,000/microl)
Patients in the modified Rai high risk group and select patients in the intermediate risk group will undergo treatment with Rituximab Fludarabine. To meet treatment criteria patients in the intermediate risk group should have evidence of active disease as demonstrated by at least one of the following criteria:
1. massive or progressive splenomegaly or lymphadenopathy;
2. presence of weight loss greater than 10% over the preceding 6 months;
3. constitutional symptoms of extreme fatigue, night sweats or recurrent fever of greater than 100 degrees F (documented fevers must be occurring without evidence of specific infection), and bone pain;
4. progressive lymphocytosis with an increase of greater than 50% over a 2 month period, or an anticipated doubling time of less than 6 months;
5. chronic infections either increased number or prolonged infections;
6. other high risk prognostic indicators such as excess elevation of beta-2-microglobulin, cluster differentiation 38 (CD38) expression and adverse cytogenetics may be used to better appraise the risk in each individual patient.
Patients with a diagnosis of CLL/SLL who do not meet the eligibility criteria for receiving Rituximab and Fludarabine (are not intermediate- or high-risk CLL/SLL), can enroll on the protocol for the purpose of donating cellular products. Such patients will not receive rituximab and fludarabine chemotherapy. At a later date, if it is documented that the patient does meet the criteria, then the patient may receive Rituximab and Fludarabine (after discussion with the Principal Investigator).
In a limited number of cases, patients with low-risk CLL/SLL may be initiated on Rituximab and Fludarabine treatment. For example, individuals who are candidates for bone marrow transplantation may be started on Rituximab Fludarabine as an induction regimen prior to transplantation. Additionally, some low-risk patients may be started on Rituximab and Fludarabine for psychological reasons (patient insistence on starting chemotherapy prior to disease progression). However, it must be stressed that low-risk CLL/SLL patients will be discouraged from initiating therapy except in these specific cases.
Age greater than or equal to 18 years of age.
Patients must have received no prior cytotoxic or monoclonal antibody therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Required initial laboratory tests: Blood urea nitrogen (BUN) and Creatinine values must be less than or equal to 1.5 times the normal values; alternatively, patients with creatinine clearance of greater than 50 ml per minute will also be eligible. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values must be less than or equal to 2.0 times normal values; patients with laboratory values greater than these levels may be enrolled on the protocol (after a specific approval from the Principal Investigator) if the values are due to a known, pre-existing liver disease. Bilirubin must be less than or equal to 2.0 mg/dl unless due to Gilbert's disease.
The patient must be competent to sign an informed consent, and sign the protocol consent form.
EXCLUSION CRITERIA:
Patients must not be pregnant or breastfeeding.
Patients with active autoimmune hemolytic anemia (AIHA)) grade III or higher (transfusion or steroids indicated) or immune thrombocytopenia (ITP) grade III or higher (platelets less than 50,000/microL) shall not be enrolled. Patients with a history of prior therapy to control either AIHA or ITP will be eligible, provided they do not require maintenance corticosteroids, and have not received monoclonal antibody therapy in the past 6 months. Patients developing AIHA or ITP on protocol may be managed as medically indicated on protocol but will generally not undergo fludarabine/rituximab treatment until resolution of hemolysis or thrombocytopenia to less than grade III.
Any patient with a medical condition that requires chronic use of corticosteroids shall not be enrolled. | 9,451 |
Study Objectives
Background:
* Research suggests that occupational exposure to formaldehyde is associated with increased risk for myeloid leukemia, but the significance of these findings is uncertain because of inconsistencies among studies and lack of knowledge of how formaldehyde can cause leukemia.
* Damage to the DNA of myeloid cells (type of white blood cell) or an environmental factor not affecting the cell genetic machinery may be involved.
Objective: To determine if formaldehyde exposure is associated with genetic or other changes in myeloid cells.
Eligibility: Workers exposed to high levels of formaldehyde and unexposed workers in Guangdong Province, China.
Design:
* 40 exposed workers and 40 unexposed workers will be enrolled.
* Subjects wear small instruments at work that measure chemicals in the air for 1 or 2 days.
* Subjects have a brief physical examination and provide blood, urine, and mouth rinse samples.
* Subjects answer a questionnaire about work, smoking and drinking, use of medicines, medical history, general health, exposure to radiation and exposure to various substances at home.
Conditions: Epidemiology, Industrial Hygiene, Neoplasms
Intervention / Treatment:
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | * Subjects will be recruited from a factory that manufactures plastic utensils and that has had a stable manufacturing process for the past five years. | 36,663 |
Study Objectives
RATIONALE: 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. AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given together with docetaxel in treating patients with solid tumors.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: AEG35156, DRUG: docetaxel
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor
* Locally advanced, metastatic, or recurrent disease that is refractory to standard curative therapy or for which no curative therapy exists
* Clinically and/or radiographically documented disease
* Docetaxel single-agent therapy must be a reasonable treatment option
* No newly diagnosed CNS metastases
* Previously treated, intracranial disease that has been stable for ≥ 6 months allowed
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin normal
* Creatinine normal
* AST and ALT ≤ 1.5 times upper limit of normal
* PT or INR normal
* PTT normal
* No known bleeding disorder
* No preexisting peripheral neuropathy ≥ grade 2
* No prior serious allergic reaction to taxanes (e.g., paclitaxel or docetaxel)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other serious illness or medical condition that would be aggravated by treatment or preclude study requirements, including any of the following:
* Serious uncontrolled infection
* Significant cardiac dysfunction
* Significant neurological disorder
PRIOR CONCURRENT THERAPY:
* No more than 2 prior chemotherapy regimens for metastatic or recurrent disease
* No more than 1 prior adjuvant chemotherapy regimen
* No more than 1 prior taxane-containing regimen
* At least 4 weeks since prior chemotherapy and recovered
* At least 4 weeks since prior external-beam radiotherapy provided \< 30% of marrow-bearing areas are irradiated\*
* At least 4 weeks since prior investigational agents or new anticancer therapy
* At least 2 weeks since prior hormonal therapy or immunotherapy
* At least 2 weeks since prior surgery and recovered
* No prior nephrectomy
* No concurrent anticoagulant therapy in therapeutic doses
* Nontherapeutic dose anticoagulant therapy (e.g., 1 mg warfarin once daily) allowed
* No other concurrent experimental drugs or anticancer therapy
* No other concurrent cytotoxic therapy or radiotherapy
* Small-volume, nonmyelosuppressive palliative radiotherapy allowed NOTE: \*Exceptions are made for prior low-dose non-myelosuppressive radiotherapy | 42,360 |
Study Objectives
The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.
Conditions: Hemangiomas
Intervention / Treatment:
DRUG: prednisolone, DRUG: methylprednisolone
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas)
* 1-4 months of age
* signed consent form
Exclusion Criteria:
* refusal to participate
* age \> 4 months
* complicated nonvisible hemangiomas
* congenital heart disease | 21,298 |
Study Objectives
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).
Conditions: Cancer
Intervention / Treatment:
DEVICE: Entia Liberty
Location: United Kingdom
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Age \>18 years old
* Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle
* Blood samples that have been stored in K2-EDTA vacutainers only
* For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
* Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
* Neutrophils (We assume WBC to behave similarly in the same ranges) Low: 0.5-1.2 x 109/L (3 samples), 1.2-2 x 109/L (2 samples) Normal: 2-7 x 109/L (3-4 samples) High: 7-12 x 109/L (1-2 samples)
* Platelets Low: 50-150 x 109/L (5 samples) Normal: 150-400 x 109/L (3 - 4 samples) High: \>400 x 109/L (1-2 samples)
* Haemoglobin Low: \<120 g/L (5 samples) Normal: 120-170 g/L (3 - 4 samples) High: \>170 g/L (1-2 samples)
Exclusion Criteria:
* History of haematological malignancy | 754 |
Study Objectives
The purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.
Conditions: Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity
Intervention / Treatment:
BEHAVIORAL: Smart Water Bottle
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Age older than 17 but less than 81.
* Non-metastatic prostate cancer patients undergoing definitive radiation treatment.
* Patients that self-identify as "smartphone owners".
* Patients with either iPhone (iOS 13.0 or higher) or Android (version 5.0.1 or higher) based smartphone access.
* English or Spanish speaking patients.
Exclusion Criteria:
* Patients with any history of pre-existing urinary retention.
* Patients with any history of kidney, urothelial tract or bladder cancer.
* Post-operative prostate patients.
* Patients that plan to be treated with pelvic lymph node radiation coverage.
* Patients without a functional bladder.
* Patients with a history of prior pelvic surgery or penile augmentation (circumcision is okay).
* Patients who have previously received any form of pelvic radiation.
* Patients unable to give informed consent.
* Patients who refuse to drink room-temperature water used for bladder filling.
* Patients without functional vision.
* Patients who are colorblind.
* Patient who refuse to use the smartphone app or who refuse consent. | 14,759 |
Study Objectives
This trial investigates how a communication strategy works in increasing human papillomavirus (HPV) vaccines in community pharmacies among adolescents. Although pharmacies are vaccine providers, low vaccination rates are persistent as a result of low awareness of pharmacy services and poor engagement by pharmacy staff with adolescents about vaccines. The purpose of this study is to test a communication strategy that identifies vaccine-eligible children and teaches pharmacy staff how to effectively communicate with them about HPV vaccination in order to increase HPV vaccination rates.
Conditions: Human Papillomavirus Infection
Intervention / Treatment:
OTHER: Communication Intervention, OTHER: Communication Skills Training, BEHAVIORAL: Healthcare Activity, BEHAVIORAL: Healthcare Activity, OTHER: Survey Administration
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* AIM 1 (PARENTS/GUARDIANS): Individuals with children between the ages of 9-17 in their care who are English speakers, live in Washington state, and have access to a telephone or computer with internet access (up to 12 parents)
* AIM 1 (PHARMACY STAFF): Employed at a Western Washington Bartell Drugs pharmacy sites and have access to a telephone or computer with internet access
* AIM 2: Pharmacy staff employed at up to four independent pharmacies in western Washington state who speak English and have access to a computer with internet access
Exclusion Criteria:
* AIM 1 (PARENTS/GUARDIANS): Those who object to having their interview audio recorded
* AIM 1 and AIM 2 (PHARMACY STAFF): Floaters/per diem. Those who object to having their interview audio recorded | 22,081 |
Study Objectives
Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be eligible for this trial.
OBJECTIVES:
To use quantitative FDG-positron emission tomography (PET), functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy \[Tannock 2004, Matsuda 2005\]. The study is exploratory to obtain proof of feasibility pilot data to support an eventual submission to the NIH.
Neuropsychological Testing A battery of testing will be used to assess the subjective complaints of cognitive impairment in the symptomatic patient cohort. Similarly the same battery of tests will be used to assure that the non-symptomatic patient control group and the age-matched normal controls do not exhibit any cognitive impairment. The following set of clinical tests will be performed to assess the degree of cognitive impairment in all subjects.
Conditions: Cancer
Intervention / Treatment:
DRUG: [18F]fluoro-2-deoxy-D-glucose (FDG)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria: Pre-screening will be conducted to ensure that all subjects are in good neurologic health with no history of seizures or other neurological disorders, and that they have no ferromagnetic implants or clips in their body. Subjects will be right-handed exclusive-English speakers with normal hearing.
Exclusion criteria: If a subject is found to have profound or severe depression after the Neuropsychological and Cognitive Testing session they may be excluded from the imaging portion of the study. This is justified as the imaging session would not be valid as the biologic correlates of depression rather than chemobrain would be imaged. Subjects found to have profound or severe depression will be notified and appropriate referral made to get them the necessary medical care to treat their depression.
Three cohorts of 8 women each under the age of 65 will be recruited for this exploratory pilot study. The "affected patient cohort" will be woman with complaints of cognitive or memory dysfunction who have received adjuvant chemotherapy for the treatment of breast cancer. These patients will be those being treated at Huntsman Cancer Hospital and be the patients of Dr Saundra Buys or Dr John Ward. The second "patient control cohort" will be age-matched woman with breast cancer who have undergone similar adjuvant chemotherapy for the same amount of time who have no complaints of memory dysfunction. Again these are primarily patients of Drs. Buys or Ward. The non-patient cohort will be age-matched woman who have not undergone any type of chemotherapy. These individuals will be recruited from friends of female family members of the two breast cancer cohorts. All individuals will be assessed for dementia and cognitive impairment using the same battery of dementia and cognitive/neuropsychological testing. All subjects will be age-matched as close as possible to eliminate age related cognitive effects. Subjects will be right-handed exclusive-English speakers with normal hearing. Pre-screening will be conducted to ensure that all subjects are in good neurologic health with no history of seizures or other neurological disorders, and that they have no ferromagnetic implants or clips in their body.
Up to 40 subjects may be enrolled to ensure 24 evaluable subjects. | 43,880 |
Study Objectives
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Conditions: Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Intervention / Treatment:
DRUG: Fluorothymidine F-18, PROCEDURE: Positron Emission Tomography, OTHER: Laboratory Biomarker Analysis, DRUG: Run-in (short pre-surgery course) of endocrine-targeted therapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* A new diagnosis of invasive breast cancer \> 1.0 cm in size, ER+ clinical stage I-III
* Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study
* Have tissue block available from core biopsy for correlative biomarkers and genomic assay
* Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as
* A prior documented bilateral oophorectomy, or
* A history of at least 12 months without spontaneous menstrual bleeding, or
* Age 60 or older with a prior hysterectomy without oophorectomy, or
* Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab
* Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients
* Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed
* Be a candidate for \[18F\]FLT PET imaging
* Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
* Be willing and able to comply with scheduled visits and other trial procedures
Exclusion Criteria:
* Current use of aromatase inhibitor as prevention or treatment for breast cancer
* Life expectancy of less than two months
* HER2/neu positive by IHC and/or another FDA approved HER2 testing method
* Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
* Weight exceeding capacity of imaging table | 26,156 |
Study Objectives
This phase I trial is studying the side effects and best dose of vorinostat when given together with bortezomib in treating young patients with refractory or recurrent solid tumors, including CNS tumors and lymphoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Conditions: Childhood Burkitt Lymphoma, Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Germ Cell Tumor, Childhood Central Nervous System Germinoma, Childhood Central Nervous System Mixed Germ Cell Tumor, Childhood Central Nervous System Teratoma, Childhood Central Nervous System Yolk Sac Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Medulloepithelioma, Childhood Meningioma, Childhood Mixed Glioma, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Childhood Oligodendroglioma, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Central Nervous System Embryonal Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: vorinostat, DRUG: bortezomib, OTHER: pharmacological study, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically confirmed solid tumors, including CNS tumors or lymphoma
* Histological confirmation not required for the following diagnoses
* Intrinsic brain stem tumors
* Optic pathway gliomas
* Pineal tumors and elevations of cerebral spinal fluid or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin, allowed
* Relapsed or refractory disease
* Must have measurable or evaluable tumor
* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* Karnofsky performance status (PS) 60-100% for patients \> 16 years of age OR Lansky PS60-100% for patients ≤ 16 years of age
* Neurologic deficits inpatients with CNS tumors must have been relatively stable for a minimum of 1week
* Patients who are unable to walk because ofparalysis, but who are up in a wheelchair, will be considered ambulatory for thepurpose of assessing the performance score
* ANC ≥ 1,000/μL
* Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions within the past 7 days)
* Patients with known bone marrow metastatic disease allowed provided they meet the blood count criteria and are not known to be refractory to platelet transfusion
* Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
* Patients with known bone marrow metastatic disease allowed provided they meet the blood count criteria and are not know to be refractory to RBC or platelet transfusion
* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age and/or gender as follows:
* 0.6 mg/dL (1 to \< 2 years of age)
* 0.8 mg/dL (2 to \< 6 years of age)
* 1.0 mg/dL (6 to \< 10 years of age)
* 1.2 mg/dL (10 to \< 13 years of age)
* 1.5 (male) or 1.4 (female) (13 to \< 16 years of age)
* 1.7 (male) or 1.4 (female) ( ≥ 16 years of age)
* Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 times upper limit ofnormal
* ALT ≤ 110 U/L
* Serum albumin ≥ 2 g/dL
* QTc interval ≤ 450 milliseconds
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be able to swallow capsules or liquids
* Able to comply withthe safety-monitoring requirements of the study, in the opinion of the investigator
* No peripheral neuropathy ≥ grade 2 within the past 14 days
* No known hypersensitivity to vorinostat or bortezomib
* No uncontrolled infection
* No concurrent enzyme-inducing anticonvulsants
* Must be recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
* At least 7 days since prior therapy with any of the following:
* Hematopoietic growth factors
* Biologic (anti-neoplastic) agent
* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
* Corticosteroids unless on a stable or decreasing dose
* At least 7 days or 3 half-lives, whichever is longer, since prior monoclonal antibodies
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior total-body irradiation therapy, craniospinal radiotherapy, or ≥ 50% of pelvis irradiated
* At least 6 weeks since prior substantial bone marrow radiotherapy
* At least 3 months since prior stem cell transplantation or rescue and no evidence of active graft-vs-host disease
* At least 2 weeks since prior and no concurrent valproic acid
* At least 6 weeks since priorimmunotherapy (e.g., tumor vaccines)
* No prior vorinostat
* No other concurrent investigational drugs or other anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy | 34,829 |
Study Objectives
The purpose of this study is to know about the quality of life of patients with metastatic renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or cure such side effects that affect patients.
Conditions: Metastatic Renal Cell Carcinoma
Intervention / Treatment:
Location: Spain
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients ≥ 18 years old and diagnosed with metastatic RCC who, in the investigator's opinion, are candidates for starting first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice.
* Patients who have no contraindications to the treatment.
* Baseline ECOG ≤ 2.
* Patients who are able to give informed consent on their own without the need for a legal representative.
* Committed patients who are able to complete the quality of life questionnaires and patient diary on their own without the need for a legal representative.
Exclusion Criteria:
* Patients who are not candidates for first-line treatment with a tyrosine kinase inhibitor.
* Patients who are receiving the treatment as second-line or subsequent therapy.
* Untreated hypothyroidism.
* Untreated severe anaemia.
* Pregnancy or breast-feeding.
* Myocardial infarction or cerebrovascular accidents (CVA) within the last 6 months.
* Severe hepatic impairment.
* Concomitant use of potent inhibitors or inducers that interact with hepatic cytochrome CYP3A4. | 31,844 |
Study Objectives
Good non-technical skills (NTS) have been shown to prevent adverse events and errors. Improvements of NTS can be achieved by simulation based-team training.The NTS of the operating theatre team performing video-assisted thoracoscopic surgery (VATS) is speculated to differ fra open thoracic surgery, as is the case with technical skills; however, these have not been investigated. The aim of this study is to explore which NTS the members of the VATS team perceive to be most important to patient care and safety. Exploration will be done through a deductive, qualitative analysis of semi-structured group and individual interviews with VATS team members. A theoretical perspective of Hollnagels Safety-II will be taken using the taxonomy of Oxford Non-Technical Skills (NOTECHS) system with the aim of informing patient safety.
Conditions: Lung Cancer
Intervention / Treatment:
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Medical doctors and medical nurses with experience in VATS by purposeful sampling.
Exclusion Criteria:
* Medical doctors and medical nurses with experience in VATS, who are included in the project group of the present study. | 24,152 |
Study Objectives
This randomized phase I trial studies the side effects and best dose of retinoid 9cUAB30 in preventing cancer in healthy volunteers. The use of retinoid 9cUAB30 may keep cancer from forming in healthy volunteers.
Conditions: Healthy Subject
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, OTHER: Placebo, DRUG: Retinoid 9cUAB30
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Normal volunteers, either male or female
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 or Karnofsky \>= 70%
* White blood cell (WBC) \>= 3000/mm\^3
* Platelets \>= 100,000/mm\^3
* Hemoglobin \> 10 g/dL
* Bilirubin =\< upper limit of institutional normal
* Aspartate aminotransferase (AST) =\< upper limit of institutional normal
* Creatinine within institutional normal limits
* Sodium, potassium, chloride, bicarbonate: all =\< upper limit of institutional normal
* Fasting triglycerides =\< 1.5 x upper limit of normal (ULN)
* Fasting cholesterol =\< 1.5 x ULN
* Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
* Heterosexual women and men must agree to use TWO effective forms of birth control for the duration of study participation and for 30 days following the last dose of study medication
* Men must agree not to donate sperm during the study and for three months after receiving the last dose of study drug
* The following persons are not considered to be able to father or bear children and therefore are eligible to participate without the use of concurrent birth control:
* Female with bilateral oophorectomy and/or hysterectomy
* Female with fallopian tubes cut, tied, or sealed
* Female with sterilization implant (e.g. Adiana, Essure) placed \> 3 months prior to randomization
* Female post-menopausal (\> 1 year since last menses)
* Male with vasectomy \> 3 months prior to randomization
* One of the following methods of birth control must be used by women of childbearing potential:
* Combined oral contraceptive pill in continuous use for \> 30 days prior to study entry
* Vaginal ring (e.g. NuvaRing) in continuous use for \> 30 days prior to study entry
* Skin patch (e.g. Ortho Evra) in continuous use for \> 30 days prior to study entry
* Injection (e.g. Depo-Provera, Noristerat) in continuous use for \> 30 days prior to study entry
* Copper intrauterine device (IUD) (e.g. ParaGard)
* Note: The following hormonal methods are NOT acceptable:
* Low dose progesterone only oral contraceptive pill ("mini pills" e.g. Micronor, Nor-Q.D., Ovrette)
* Norplant subdermal implant
* Mirena Hormonal Implanted Uterine Device (IUD)
* In addition to the above method of contraception, one of the following methods of contraception will ALSO be used for the duration of study participation and for 30 days following the last dose of study medication:
* Diaphragm, cervical cap, or cervical shield with spermicide
* Contraceptive sponge (e.g. Today Sponge)
* Condom (male or female type) plus spermicide
* Females of child-bearing potential must have a negative pregnancy test within the current menstrual cycle and within 7 days before starting drug
* Participants must have the ability to understand, and the willingness to sign, a written informed consent document
Exclusion Criteria:
* Participants may not be taking medications that might interact with 9cUAB30
* Participants may not be taking lipid lowering agents
* Participants may not receive any other investigational agents within 30 days of enrollment nor during study participation
* Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition of retinoids
* Participants with an 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
* Breastfeeding must be discontinued for the duration of study participation and for one month after the last dose of the study agent if the mother is treated with 9cUAB30
* Individuals known to be human immunodeficiency virus (HIV)-positive may not participate in this study
* Individuals with a history of cancer diagnosis or reoccurrence \< 5 years from study entry may not participate; however, individuals with a history of squamous or basal cell carcinoma of the skin \< 5 years from study entry will not be excluded from this study | 19,365 |
Study Objectives
A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population.
ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts.
ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus.
ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection.
ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection.
Participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection.
It is hoped this research will provide insight into the best practice for prevention and treatment of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.
Conditions: Cancer, Covid19, Respiratory Viral Infection
Intervention / Treatment:
DRUG: Interferon alfa, DRUG: Selinexor, DRUG: Lenzilumab
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: QUADRUPLE | Inclusion Criteria:
* ARM 1:
1. Age equal to or greater than 18 years old
2. Any haematological or solid tumour
3. Signed written and verbal informed consent
4. Willingness to inform the study nurse/co-ordinator of COVID-19 testing
5. Willingness to perform a self-collect nose/throat swab
ARM 2
1. Age equal to or greater than 18 years old.
2. Any haematological or solid tumour
3. Signed written and verbal informed consent
4. Have been exposed to a known COVID-19 case within the last 72 hours, defined by the current Department of Health and Human services such as household contact, 15 minutes of face to face exposure, 2 hours in close space.
5. Willingness to inform the study nurse/co-ordinator of COVID-19 testing
6. Willingness to perform a self-collect nose/throat swab
ARM 3 1. Age equal to or greater than 18 years of age. 2. Any haematological or solid tumour 3. Current or within the last 12 months received cancer related treatment such as chemotherapy, radiotherapy or targeted small molecule, cellular therapy or immune-modulating therapy 4. Signed written and verbal informed consent 5. Laboratory confirmation of SARS-CoV-2 by PCR as per local laboratory assays 6. Hospitalised 7. Symptoms of COVID-19 such as:
1. Fever equal to or greater than 38 degrees Celsius OR
2. Tachypnoea respiratory rate equal to or greater than 20 breaths/min OR
3. Pulse Oxygen saturation (SpO2) equal to or less than 94% 8. Concurrent standard of care antimicrobials, antivirals are allowed. 9. Female and male patients of child bearing potential will use highly effective contraception. In female child bearing potential participants a negative urine pregnancy test will be required.
ARM 4
1. Age equal to or greater than 18 years of age.
2. Any haematological or solid tumour
3. Current or within the last 12 months received cancer related treatment such as chemotherapy, radiotherapy or targeted small molecule, cellular therapy or immune-modulating therapy
4. Signed written and verbal informed consent by participant or proxy capable of giving consent
5. Laboratory virological confirmation of SARS-CoV-2 by PCR as per local laboratory assays and COVID-19 diagnosis prior to randomisation
6. Hospitalised but has not required mechanical ventilation
7. Pneumonia diagnosed by chest x-ray or computed tomography (CT) revealing infiltrates consistent with pneumonia and SpO2 equal to or less than 94% on room air or requires low-flow oxygen supplementation or requires high-flow oxygen supplementation or non-invasive positive pressure ventilation (NIPPV).
8. Has not participated in other clinical trials for COVID-19 using an immunomodulating monoclonal antibody or kinase inhibitor. Note that participants on dexamethasone, corticosteroids, remdesivir, convalescent plasma and/or hydroxychloroquine with or without azithromycin are not excluded from the study. Agents that have received emergency use authorization and/or are considered by the study site to be standard treatment at the institution for COVID-19 are permitted provided the agent is not an immunomodulating monoclonal antibody or kinase inhibitor. Participation in clinical trials with remdesivir or convalescent plasma is permitted provided that all other eligibility criteria are met.
9. Females of childbearing potential must have a negative serum or urine pregnancy test at screening/baseline. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 5 months following their last dose of study drug.
Exclusion Criteria:
* ARM 1
1. Previous diagnosis of COVID-19 (microbiologically proven, either symptomatic or asymptomatic)
2. Have been exposed to a known COVID-19 case within the last 72 hours, defined by the current Department of Health and Human services such as household contact, 15 minutes of face to face exposure, 2 hours in close space.
3. Any contra-indication to intra-nasal IFN-a such as severe nasal bleeding requiring intervention, nasal malignancy, nasal deformity, radiotherapy to the nasopharynx and/or oropharynx
4. Pregnant or breast-feeding women, or women who wish to become pregnant during the course of the study
5. Participant unable to return for regular follow-up
6. Life expectancy of less than 4 months
7. Participant already included in another intervention study on the prevention of COVID-19
8. Currently unwell with influenza-like symptoms - if participant is found to be COVID-19 negative and becomes asymptomatic, they can be reconsidered for participation
ARM 2
1. Previous diagnosis of COVID-19 (microbiologically proven, either symptomatic or asymptomatic)
2. Any contra-indication to intra-nasal IFN-a such as severe nasal bleeding requiring intervention, nasal malignancy, nasal deformity, radiotherapy to the nasopharynx and/or oropharynx
3. Pregnant or breast-feeding women, or women who wish to become pregnant during the course of the study
4. Patient unable to return for follow-up
5. Life expectancy of less than 1 month
6. Patient already included in another intervention study on the prevention of COVID-19
7. Currently unwell with influenza-like symptoms
ARM 3
1. Unable to take oral medication
2. Any known allergic reactions to selinexor or concomitant medication-related contra-indications to selinexor.
3. Severe critical COVID-19 infection defined as:
1. Requiring invasive or non-invasive mechanical ventilation, ECMO
2. Anticipated unlikely to survive within 48 hours
4. In the opinion of the investigator and primary oncologist, participation in the study would not be in the best interests of the participant
5. Severe renal impairment defined as creatinine clearance (CrCL) \< 20ml/min as calculated using the Cockcroft Gault formula
6. Severe hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) \> 5 x upper limit of normal (ULN)
ARM 4
1. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 2. History of pulmonary alveolar proteinosis (PAP). 3. Women of childbearing potential who are pregnant or breastfeeding. 4. Known hypersensitivity to lenzilumab or any of its components. 5 .Use of any FDA-approved anti-IL-6 therapy (eg. tocilizumab, sarilumab, siltukimab), anti-IL-1 therapy (eg. anakinra, canakinumab) or kinase inhibitor (eg.baracitinib, ibrutinib, acalabrutinib) therapy to treat COVID-19 within 8 weeks prior to randomization. Any live vaccine within 8 weeks prior to randomisation. Note that subjects receiving other FDA-approved immunomodulators to treat underlying autoimmune disorders such as rheumatoid arthritis, psoriasis, ankylosing spondylitis, asthma, chronic obstructive pulmonary disease, atopic dermatitis, multiple sclerosis, etc. would not be excluded. Participants on corticosteroids or dexamethasone are not excluded from the study. Note: Participants on convalescent plasma, remdesivir and/or hydroxychloroquine with or without azithromycin are not excluded from the study.
6. Use of GM-CSF agents (e.g., sargramostim) within 8 weeks prior to randomisation.
7. Expected survival \< 24h in the opinion of the investigator. 8. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the subject at unacceptably high risk from the study.
9. Participation in another interventional study of COVID-19 | 11,124 |
Study Objectives
The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients diagnosed with lung cancer. Participants will be enrolled in four groups according to their primary therapy (A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy). According to sample size calculations the investigators will include a total of N = 450 patients, but inflating the recruitment goal is permissible.
Conditions: Lung Cancer
Intervention / Treatment:
OTHER: Surgery, OTHER: Radiochemotherapy, OTHER: Targeted therapy, OTHER: Immunotherapy
Location: Germany
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* histologically confirmed diagnosis of lung cancer
* no previous primary or recurrent tumour
* ability to understand the language of the questionnaire
* mental fitness to complete a questionnaire
* 18 years of age or above
* written informed consent.-
Exclusion Criteria:
* no histologically confirmed diagnosis of lung cancer-
* previous primary or recurrent tumour
* not mentally fit to complete a questionnaire
* not able to understand the language of the questionnaire
* younger than 18
* refusal of informed consent. | 20,564 |
Study Objectives
This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1 inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer who no longer have evidence of disease. Antigens (such as cancer/testis antigen \[NY-ESO-1\] protein) are found on many cancer cells. Vaccines made from NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells. By finding them, the immune system may then work to control or eliminate the remaining cancer cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase (IDO). This enzyme is produced by tumor cells to disable immune cells, and limit the efficacy of immune attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC and IDO1 inhibitor INCB024360 may generate stronger and more long lasting anti-cancer immune responses in patients with ovarian, fallopian tube, and primary peritoneal cancer in remission.
Conditions: Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma
Intervention / Treatment:
BIOLOGICAL: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, DRUG: Epacadostat, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, DRUG: Poly ICLC
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Eligible patients will be women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease; this may or may not be measurable; these patients would normally enter a period of observation after standard management
* Any human leukocyte antigen (HLA) type; (historic HLA typing is permitted)
* Tumor expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) and/or reverse transcriptase polymerase chain reaction (RTPCR)
* Life expectancy \> 6 months
* Absolute neutrophil count (ANC) \>= 1,000/uL
* Platelets (PLT) \>= 100,000/uL
* Hemoglobin (Hgb) \>= 8 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Serum aspartate aminotransferase (serum glutamic oxaloacetic transaminase \[SGOT\]/AST) or serum alanine aminotransferase (serum glutamate pyruvate transaminase \[SGPT\]/ALT) =\< 3 x ULN
* Serum creatinine =\< 2 x ULN
* Have been informed of other treatment options
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* The ability to swallow and retain oral medication
* Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
* Patients may have received previous NY-ESO-1 vaccine therapy; patients who received maintenance paclitaxel or bevacizumab are eligible for enrollment provided they have discontinued therapy (at least 4 weeks for prior taxane or prior bevacizumab) prior to randomization and recovered from toxicities to less than grade 2
Exclusion Criteria:
* Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available
* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
* History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
* Concomitant systemic treatment with chronic use (based on the investigator's judgment) of corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs, and other platelet inhibitory agents
* Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study drug (6 weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
* Subjects being treated with a monoamine oxidase inhibitor (MAOI), or drug which has significant MAOI activity (e.g., Meperidine, linezolid, methylene blue) within 3 weeks prior to screening
* Subjects who are currently receiving therapy with a potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir)
* Use of UDP glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: diclofenac, imipramine, and ketoconazole
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study drug
* Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
* Lack of availability of a patient for immunological and clinical follow-up assessment
* Evidence of current drug or alcohol abuse or psychiatric impairment, which in the Investigator's opinion will prevent completion of the protocol therapy or follow-up
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the patient's risk by participating in this study)
* Known hypersensitivity to any of the study drugs that will be given to the participant
* Additional exclusion criteria for exploratory cohort ONLY: Known pulmonary hypertension | 43,645 |
Study Objectives
RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system in children who are undergoing stem cell transplantation.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in reducing inflammation of the mouth and digestive system in children who are undergoing peripheral stem cell transplantation.
Conditions: Oral Complications, Unspecified Childhood Solid Tumor, Protocol Specific
Intervention / Treatment:
DIETARY_SUPPLEMENT: glutamine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS: Undergoing allogeneic or autologous stem cell transplant (including bone marrow, cord blood, or peripheral blood stem cells) Conditioning regimen must have at least 50% risk of grade III or IV mucositis No grade III or IV hepatic toxicity
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No grade III or IV toxicity at admission for stem cell transplant No altered mental status
PRIOR CONCURRENT THERAPY: No concurrent vancomycin paste or nonabsorbable antibiotics | 39,488 |
Study Objectives
The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF), rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term disease-free survival. Though less grave, the prognosis for cure for other high-risk patients is approximately 50%. New treatment strategies, including the identification of highly active new agents, maximizing the dose intensity of the most active standard drugs, and the development of improved methods of consolidation to eradicate microscopic residual disease, are clearly needed to improve the outcome of these patients. This protocol will address these issues by commencing with a Phase II window, for the highest risk patients, to evaluate a series of promising drugs with novel mechanisms of action. All patients will then receive 5 cycles of dose-intensive "best standard therapy" with doxorubicin (adriamycin), vincristine, and cyclophosphamide (VAdriaC). Patients at high risk of relapse will continue onto a phase I consolidation regimen consisting of three cycles of dose-escalated Melphalan, Ifosfamide, Mesna, and Etoposide (MIME). Peripheral blood stem cell transfusions (PBSCT) and recombinant human G-CSF will be used as supportive care measures to allow maximal dose-escalation of this combination regimen.
Conditions: Ewing's Sarcoma, Neuroblastoma, Rhabdomyosarcoma
Intervention / Treatment:
DRUG: ADR-529, DRUG: Topotecan, DRUG: G-CSF
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | The patient must fall into one of the following diagnostic categories:
Ewing's sarcoma family of tumors (ESF): Includes Ewing's sarcoma (classic, atypical, extra-osseous), primitive sarcoma of bone, ectomesenchymoma, or peripheral primitive neuroectodermal tumor (peripheral neuroepithelioma).
Rhabdomyosarcoma: The patient must have either
High-risk arm: Metastatic disease at diagnosis (any site, any histology);
OR
Moderate-risk arm: Incompletely resected ( Clinical Group III) Stage II tumors and ALL stage III tumors (regardless of degree of surgical resection).
Neuroblastoma: Any patient with metastatic disease at diagnosis (POG stage D or Evans' stage IV); or, patients with loco-regional metastatic disease (POG stage C) or tumor infiltrating across the midline (Evans' stage III) IF they have an elevated serum ferritin (greater than 142 ng/ml), an amplified N-myc copy number (greater than 10 copies on Southern analysis), or a DNA index of greater than 1.1.
The patient must not have been previously treated with chemotherapy or radiation therapy.
Patients must be greater than or equal to 1 year of age but less than or equal to 25 years of age. Patients weight must be greater than or equal to 15 kg.
The patient (or his/her guardian if less than 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected.
Potentially fertile female patients must have a documented negative urine or serum pregnancy test.
Patients must have a documented negative HIV serologic evaluation (Western Blot and/or ELISA).
Patients must not have abnormal cardiac function (left ventricular ejection fraction less than 45% as measured by gated equilibrium radionuclide angiography \[MUGA scan\] and confirmed by echocardiography).
Patients must not have impaired renal function (serum creatinine greater than or equal to twice the upper limit of normal for age).
Patients with a total bilirubin of greater than 4.0 mg/dl (or a direct bilirubin of greater than 2.0 mg/dl) or SGOT/SGPT greater than five times the upper limits of normal (NOT on the basis of hepatic involvement by tumor) will be excluded.
Patients with a second malignancy following previous therapy will be excluded.
Patients previously treated with chemotherapy or radiation therapy (other than limited, emergency radiation therapy) will be excluded.
Patients who are HIV-infected will be excluced. | 25,531 |
Study Objectives
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month, less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. However, its overall effect is not yet satisfactory. As a result, concerning the research of drug for liver cancer and improving the overall efficacy of the treatment of liver cancer has a very real and important clinical significance and social value. Licartin (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
Conditions: Unresectable Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: Licartin, PROCEDURE: Transcatheter arterial chemoembolization
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
2. diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
3. confirmed to recurrent after surgery by pathology;
4. KPS score of physical state ≥ 60 points;
5. liver function is Child-Pugh A or B class
Exclusion Criteria:
1. General situation is poor and liver function Child-Pugh is C class;
2. there is a serious heart, kidney and blood system diseases in patients;
3. poor compliance;
4. there is allergy history of biological agents or in a state of allergy;
5. pregnancy and breast-feeding women | 7,369 |
Study Objectives
The purpose of the study to assess the efficacy of adding L-carnitine to clomiphene citrate for increasing the ovulation and the pregnancy rate in women with PCOS.
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
DRUG: oral clomiphene citrate, DRUG: oral carnitine supplementation
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
1. Age ranging from 18-35 years.
2. Normal Hysterosalpingo-graphy (HSG).
3. Normal Semen analysis of the husband.
4. Diagnosed with PCOS based on the (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria 2003).
Exclusion Criteria:
1. Patient's refusal.
2. Male factors of infertility and/or abnormal HSG.
3. Hyperprolactinemia (prolactin ≥ 22 ng/dl).
4. FSH on day 3 \> 15 mIU/mL.
5. Gross ovarian pathology diagnosed by ultrasound. | 36,633 |
Study Objectives
To enhance information transfer and decision making for women with breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: Standard Decision Board, PROCEDURE: Computer Decision Board, PROCEDURE: Paper Decision Board
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose:
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
Chemotherapy Group:
* Female
* Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy
* Axillary node dissection
* Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option
Surgery Group:
* Female
* Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy
* Clinical stage I or II disease
* Candidate for breast conserving surgery
Exclusion Criteria:
Chemotherapy Group:
* Candidate for CEF chemotherapy
* Clinical evidence of metastatic disease
* Serious comorbidity that would preclude receiving chemotherapy treatment
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making
Surgery Group:
* Previous surgery for breast cancer
* Previous breast irradiation
* Pregnant
* Clinical suspicion of bilateral breast cancer
* Serious comorbidity that would preclude definitive surgery
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making | 19,007 |
Study Objectives
The study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria.
Conditions: Primary Central Nervous Lymphoma, Intraocular Lymphoma
Intervention / Treatment:
DRUG: Ibrutinib
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Histologically confirmed diagnosis of PCNSL or cytologically proven diagnosis of IOL or lymphomatous meningitis of B-cell type. In case of CNS lymphoma relapse or refractory PCNSL, cerebral biopsies are not required if imaging reveals typical images of PCNSL. In case of isolated IOL relapse, vitrectomy is not required if i) vitrectomy was part of the initial diagnosis workout, and ii) ocular examination and dosage of IL-10 in the anterior chamber of the eye performed at relapse or progression are highly in favour of IOL relapse (\> 50 pg/ml in aqueous humor or 400 pg/ml in vitreous).
2. Aged 18 years and older.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
4. Life expectancy ≥ 3 months.
5. No more than 4 lines of anti-cancer treatment received.
6. Patients must have recovered within 28 days to a grade ≤ 1 from all toxicities related to prior treatments.
7. Adequate Laboratory Parameters within 14 days:
8. Measurable PCNSL as diagnosed on MRI
9. Highly effective method of birth control during and after the study consistent. Men must agree to not donate sperm during and after the study. These restrictions apply for 1 year after the last dose of study drug.
10. Women of childbearing potential must have a negative serum beta-hCG or urine pregnancy test at Screening.
11. Sign of an informed consent document.The informed consent document can be signed by a person of confidence in case neurologic disorders related to the disease prevent the patient to sign himself.
Exclusion Criteria:
1. Contraindication to any excipients of the drug.
2. T-cell lymphoma.
3. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast), prior history of systemic lymphoma, unless the patient has been free of the disease for ≥ 3 years.
4. Prior history of organ transplantation or other cause of severe immunodeficiency.
5. Major surgery, within 4 weeks prior to the first dose of study drug.
6. History of stroke or intracranial hemorrhage within 6 months prior to randomization. Patients with post-biopsies hemorrhagic sequela defined as a small hyperdense lesion \< 3 mm on T2\* sequence won't be excluded.
7. Requires anticoagulation with warfarin or equivalent vitamin K antagonists or ongoing warfarin medication or other equivalent vitamin K antagonists.
8. Any anti-platelet aggregant medication except acetyl salicylic acid ≤ 75 mg/day.
9. Requires treatment with strong CYP3A4 inhibitors.
10. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or Class 4 cardiac disease as defined by the New York Heart Association Functional Classification.
11. Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study drug.
12. Known history of HIV or active Hepatitis C Virus (HCV; RNA polymerase chain reaction \[PCR\]-positive) or active Hepatitis B Virus (HBs Ag positive or DNA PCR-positive) infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
13. Any life-threatening illness, medical condition, or organ system dysfunction which could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
14. Inability to swallow capsules.
15. Pregnancy or lactation.
16. Use of anti-cancer drug therapy within 21 days prior to the first dose of study drug.
17. Previous treatment by BTK inhibitors and PI3K inhibitors.
18. Known bleeding diathesis.
19. Inclusion in another experimental anti-cancer drug therapy\*.
20. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
21. Patient under measure of legal protection.
22. No social security affiliation. | 14,940 |
Study Objectives
BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.
Conditions: Multiple Myeloma
Intervention / Treatment:
OTHER: No Intervention
Location: Japan
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study
Exclusion Criteria:
* Not Applicable | 41,488 |
Study Objectives
The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be analysed.
Conditions: Insulin Resistance, Polycystic Ovary Syndrome, Hyperandrogenism, Obesity
Intervention / Treatment:
DIETARY_SUPPLEMENT: Lactobacillus group, DIETARY_SUPPLEMENT: Dietary group
Location: Poland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion criteria:
* patients diagnosed with PCOS,
* BMI\> 28 kg/m2 (overweight or obesity),
* patients not participating in other similar research programs at the same time,
* no previous operations on ovaries such as: laparoscopy, ovarian cautery etc.,
* written agreement to take part in the research.
Exlusion criteria:
* the use of antibiotics or probiotics within 6 months before the start of the experiment,
* the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months,
* the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
* failure to comply with dietary recommendations established during the nutritional intervention,
* the use of weight loss supplements during the study,
* clinical diagnosis of digestive disease (for example: irritable bowel syndrome, ulcerative colitis, Crohn's disease, celiac disease),
* pregnancy and breast feeding. | 24,896 |
Study Objectives
In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for autologous transplantation. One of the cited advantages of this procedure is the avoidance of bone marrow harvest, which frequently requires general anesthesia. Other advantages include faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the amount of tumor contamination and technical ability to obtain stem cells from patients previously considered unharvestable because of marrow fibrosis or because of prior radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell mobilization based on its safety profile and the positive experience in granulocyte donors however, the number of circulating CD34+ cells does not occur until the third day after starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of neutrophil precursors and enhances the functions of mature neutrophils in the same manner as filgrastim. Data form normal volunteers and in studies of patients with cancer have shown prolonged serum levels of the cytokine, with "self-regulation" of pegfilgrastim levels as a function of the neutrophil count. This confers a therapeutic advantage in clinical settings by allowing a less frequent dosing.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Pegfilgrastim (Neulasta), PROCEDURE: Apheresis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: PREVENTION
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. 1. Age 18 years or older
2. Patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation and PBPC cell collection without chemopriming.
3. Zubrod performance status \< 3 (Appendix E)
4. Serum bilirubin \< 1.5 times the upper limit of normal, serum SGOT and SGPT \< 2 times the upper limit of normal, serum creatinine \< 2.0 mg/dl
5. WBC \> 3,500/ul
6. Platelet count \> 100,000/ul prior to first apheresis procedure
7. Patients should not have received prior chemotherapy. Only patients who have been treated with thalidomide, bortezomib, +/- dexamethasone will be eligible.
8. Sufficient peripheral venous access or central venous catheter
9. Informed consent
Exclusion Criteria:
1. Serious intercurrent medical illness
2. History of bleeding disorders (except patients with treated, myeloma related bleeding disorders)
3. Untreated hypercoagulation abnormalities
4. Patients with prior history of pulmonary embolism, deep venous thrombosis requiring anticoagulant therapy, or placement of a venous filter.
5. Untreated symptomatic cardiac disease defined as left ventricular EF of \<40% and NYHA functional class of \> II (Appendix F)
6. Uncontrolled infection defined as fever or antibiotics within 72 hours of registration.
7. History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
8. Palpable splenomegaly or craniocaudal spleen length greater than 12 cms
9. Pregnancy
10. Use of aspirin, ibuprofen containing products within 7 days of enrollment
11. History of uncontrolled autoimmune disorder
12. Sickle cell trait/sickle cell disease
13. Women who are lactating or breast feeding
14. 14. Patients with abnormal cytogenetics that may be secondary to myelodysplasia (-5, -7 and 11q23 abnormalities) will be excluded
15. Peripheral vascular disease | 7,809 |
Study Objectives
The PERCY Quattro trial has been designed to evaluate the survival benefit of two cytokine treatments, Interleukin-2 (IL2) and/or alpha interferon (IFN), for patients with intermediate chance of response in metastatic renal cell carcinoma.
Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and IL2.
The primary objective of the study is overall survival; secondary objectives are progression-free survival, response rate, toxicity, and quality of life.
Conditions: Metastatic Renal Cell Carcinoma
Intervention / Treatment:
DRUG: Interleukin-2, DRUG: Interferon alfa, DRUG: medroxyprogesterone acetate
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Progressive histologically proven metastatic renal cell carcinoma.
* Patient with only 1 metastatic site and Karnofsky = 80% or more than 1 metastatic site and Karnofsky \>= 80%.
* Age \>= 18
* No wide-field radiation therapy for 6 weeks at least.
* No active brain metastasis.
* Blood values within limits of normal (hematocrit \> 30% and leukocyte count \>= 4x109/l and platelet count \>= 120x109/l).
* Creatinine \< 150 µmol/l and bilirubin \<= normal.
* Female patients of childbearing potential: effective method of contraception is necessary.
* Written, voluntary, informed consent.
Exclusion Criteria:
* Previous treatment with cytokines.
* Only one metastatic organ and Karnofsky = 90% or 100% (inclusion in good prognosis group).
* More than one metastatic organ (at least one metastasis to the liver) and \<12 months between initial diagnosis and diagnosis of metastasis.
* Active brain metastases.
* Patient with concurrent grade III/IV heart disorder (congestive heart failure, coronary artery disease, uncontrolled hypertension, severe arrhythmia, etc) and/or stroke volume \< 50%.
* Severe pulmonary, hepatic, or renal disease potentially aggravated by treatment.
* Severe concurrent infection necessitating antibiotics
* Patient with known HIV or AIDS-related disease, or presence of HB antigen or known chronic hepatitis.
* Previous allograft.
* Patient under corticosteroid treatment.
* Previous or concurrent primary malignancies at other sites (except from baso-cellular skin cancer or cervical cancer in situ)
* Pregnant or lactating woman.
* Follow-up difficult because of geography or personal circumstances. | 8,295 |
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