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Study Objectives
This multicenter, open-label study will evaluate the effect of posaconazole on the pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781 formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with solid tumors.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: RO5503781, DRUG: RO5503781, DRUG: RO5503781, DRUG: RO5503781, DRUG: posaconazole
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose:
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed advanced malignancies, except all forms of leukemia and lymphoma, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
* Measureable or evaluable disease (by RECIST criteria version 1.1 for solid tumors prior to the administration of study drug
* Life expectancy of \>/= 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Female patients of childbearing potential and male patients who are not surgically sterile must be willing to use effective methods of contraception as defined by protocol during the treatment period and for 10 days after the last dose of RO5503781.
* There are no limitations on additional, allowable type and amount of prior anti-tumor therapy. Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy must have resolved to NCI-CTCAE version 4.03 Grade \</= 1. The last dose of prior therapy must \>/= 21 days prior to the first administration of study drug RO5503781 (or \>/= 5 x terminal half-life of that therapy).
* Adequate bone marrow, hepatic and renal function
* Patients with stable CNS metastases (have had therapy or do not require therapy, are off steroids, have no change on screening CT or MRI and are asymptomatic), are eligible
Exclusion Criteria:
* Any form of leukemia except for Stage 0 and 1 chronic lymphocytic leukemia (CLL) not requiring treatment in addition to the underlying malignancy
* Hormonal therapy within the 2 weeks prior to the first dose of study medication. Patients with prostate cancer who are not surgically castrated should remain on GnRH analogues.
* Patients who are using other investigational agents or who received investigational drugs \</= 4 weeks prior to study treatment start.
* Pre-existing GI disorders that may interfere with proper absorption of the drug(s), as per investigator discretion.
* History of allergic reactions attributed to components of the formulated product
* History of seizure disorders or unstable CNS metastases
* Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Patients who must receive CYP2C8 inhibitors, substrates or inducers, strong CYP 3A4 inducers or moderate/strong CYP3A4 inhibitors listed in protocol while on study. Substrates, inducers, and inhibitors listed in protocol must be discontinued 7 or 14 days prior to start of study medication.
* Evidence of electrolyte imbalance (treatment for correction of electrolyte imbalances is permitted during screening to meet eligibility)
* Pregnant or breast feeding women
* HIV-positive patients who are currently receiving combination anti-retroviral therapy
* Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia.
* Patients receiving oral or parenteral anticoagulants/antiplatelet agents (e.g., chronic daily treatment with aspirin (\> 325 mg/day), clopidogrel, low molecular weight heparin, or subcutaneous anticoagulant prophylaxis). A washout period of at least 7 days prior to the start of study is required. Patients may receive anticoagulant flushes for maintenance of indwelling catheters.
* Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
* Part 1 only: Hypersensitivity to posaconazole, or any of the other ingredients, or any other azole antifungal
* Part 1 and Part 3: Patients who cannot tolerate high-fat and/or full meals. | 24,253 |
Study Objectives
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may stop the growth of tumor cells in bone. Giving bevacizumab together with cyclophosphamide and zoledronic acid may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving bevacizumab together with cyclophosphamide and zoledronic acid in treating patients with recurrent or refractory high-risk neuroblastoma.
Conditions: Neuroblastoma
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: cyclophosphamide, DRUG: zoledronic acid
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must be no more 30 years of age when enrolled on study.
* Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to standard treatment.
* Patients who have at least a partial response to standard treatment who still have neuroblastoma that can be seen on CT/MRI or MIBG scans must have a surgical biopsy done of the tumor to confirm that it is neuroblastoma. Patients with relapsed or refractory neuroblastoma do not need to have a biopsy done to enter on study.
* Patients must have adequate heart, kidney, liver blood clotting and bone marrow function. Patients who have bone marrow disease must meet the bone marrow function criteria to enter the study.
* Patients must have recovered from all prior chemotherapy and surgical procedures
Exclusion Criteria:
* They are known to be sensitive to Bevacizumab.
* They have a history of very high blood pressure which required intensive intervention
* They are pregnant or breastfeeding
* Neuroblastoma is present in the brain on a CT or MRI scan done at study entry. Patients with neuroblastoma found in the bones of the skull are eligible if there is no tumor mass associated with them pressing on the brain.
* They have a history non healing wounds | 1,016 |
Study Objectives
The objective of this study is to characterize the safety profile and determine the maximum tolerate dose (MTD) of BXQ-350, when given as a single agent at escalating doses, according to the investigational product (IP) related dose-limiting toxicities (DLTs) in patients with advanced solid tumors. Secondarily to assess the preliminary antitumor activity of BXQ-350 in solid tumors and recurrent high grade gliomas.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: BXQ-350
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:
* Each patient must meet the following criteria:
1. Provide signed, written informed consent prior to the initiation of any study-specific procedures
2. Have histologically or cytologically confirmed diagnosis of advanced solid tumor cancer (excluding lymphomas) for which there is no further standard therapy or when standard therapy is contraindicated. Patients with HGG must have shown unequivocal evidence for recurrence or progression by MRI scan or must have histologically proven tumor recurrence.
3. Patients with HGG: Have previously received radiotherapy and temozolomide
4. For patients with HGG and receiving glucocorticoid therapy, must be on stable or decreasing equivalent daily dose of glucocorticoids for 2 weeks (14 days) prior to dose assignment
5. Have measurable or non-measurable disease per RECIST 1.1 criteria for solid tumors and RANO criteria for HGG
6. Are males or females aged ≥ 18 years
7. Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2
8. Have acceptable liver function defined as:
* Total serum bilirubin ≤ 1.5 × upper limit of normal for the study site (ULN) (in patients with known Gilbert Syndrome, total bilirubin ≤ 3 × ULN, with direct bilirubin ≤ 1.5 × ULN)
* Aspartate Transaminase (AST), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alanine Transaminase (ALT), Serum Glutamic-Pyruvic Transamine (SGPT) ≤ 3 × ULN (if liver metastases are present, then ≤ 5 × ULN is allowed)
* Serum albumin ≥ 3 g/dL
9. Have acceptable renal function defined as:
Serum creatinine ≤ 1.5 × ULN, OR calculated creatinine clearance ≥ 45 mL/min for patients with creatinine levels above 1.5 mg/dL
10. Have acceptable bone marrow function defined as:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
* Platelet count ≥ 100,000 cells/mm3
* Hemoglobin \> 9.0 g/dL
11. Have acceptable coagulation parameters defined as:
* International normalized ratio (INR) ≤ 2 × ULN
* Activated partial thromboplastin time (aPTT) within normal limits
12. Have a negative serum pregnancy test result at screening (for females of child bearing potential (FCBP); not applicable to patients who are unable to become pregnant, including those with tubal ligation, bilateral oophorectomy and/or hysterectomy, post-menopausal is defined as \> 12 months since last menstrual cycle)
13. FCBP and male patients whose sexual partner(s) are FCBP must agree to abstain from heterosexual activity or use a double barrier method of contraception (e.g., condom and occlusive cap with spermicide) or highly effective contraception (intrauterine device or system, established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle, or vasectomized partner with confirmed azoospermia) from the time of study entry to 1 month after the last day of treatment
Exclusion Criteria:
* Patients must not meet any of the following criteria:
1. Have a concurrent malignancy or have had another malignancy within 1 year prior to initiation of screening (with the exception of adequately treated basal or squamous cell carcinoma, melanoma in situ, early-stage prostate cancer (T1a-cN0M0), ductal carcinoma in situ of the breast or cervical carcinoma in situ)
2. Patients with solid tumors: Have received anticancer therapies, including radiation therapy, cytotoxic agents, targeted agents or endocrine therapy within 2 weeks prior to dose assignment
3. Patients with HGG: Have received anticancer therapies including: radiation therapy to current site of disease within 12 weeks of dose assignment, targeted agent therapy within 2 weeks of dose assignment, nitrosoureas within 6 weeks of dose assignment, procarbazine within 3 weeks of dose assignment, or other cytotoxic agents within 4 weeks of dose assignment
4. Have not recovered from toxicity of prior therapy defined as a return to \< grade 1 at the time of dose assignment, graded according to CTCAE v4.03 (excluding alopecia, neuropathy, and lymphopenia)
5. Have received prior treatment with any investigational drug within 4 weeks prior to dose assignment
6. Have had major surgery other than a minor outpatient procedure within 4 weeks prior to dose assignment or have not recovered from major side effects of the surgery if more than 4 weeks have elapsed since surgery
7. Have a history of cardiac dysfunction including:
* Myocardial infarction within 6 months prior to initiation of screening
* History of documented congestive heart failure (New York Heart Association functional classification III-IV) within 6 months prior to initiation of screening
* Active cardiomyopathy
* ECG with correctd QT interval (QTc) \>450 msec in males or \>470 msec in females at screening
8. Have a known history of HIV seropositivity
9. Are pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test
10. Have symptomatic brain metastases or leptomeningeal disease
11. Have active (acute or chronic) or uncontrolled severe infections
12. Have active poor wound healing (delayed healing, wound infection or fistula)
13. Have poorly controlled hypertension defined as blood pressure \>160/90 on at least 2 repeated determinations on separate days within 2 weeks (14 days) prior to initiation of screening
14. Have evidence of active clinically significant bleed (e.g., gastrointestinal bleed, hemoptysis, or gross hematuria) at screening
15. Have other concurrent severe and/or uncontrolled medical condition that would, in the site Investigator's judgment contraindicate the patient's participation in the clinical study | 25,851 |
Study Objectives
This study evaluates a web-based decision aid, named RealRisks, in promoting genetic testing intention among Orthodox Jewish women. 50 Orthodox Jewish women will take a baseline survey, self-administer the decision aid, and then complete two more surveys: one within one month of completing the decision aid and one at 6 months after completing the decision aid.
Conditions: Breast Cancer
Intervention / Treatment:
BEHAVIORAL: RealRisks
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* \>= 25 years of age
* Completed a previous cross-sectional survey and agreed to future contact
* Eligible for BRCA testing based on Six Point Scale
Exclusion Criteria:
* Personal history of breast or ovarian cancer
* Prior genetic counseling or genetic testing for BRCA mutations
* Participated in previous RealRisks workshop | 40,397 |
Study Objectives
Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years, much more than children, suffer from delay in diagnosis, lack of centralization of care, age-adjusted expertise and follow-up care. The distribution of tumor types, biology, risk factors, developmental challenges and treatment regimens are different in AYAs compared to children. Therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Likewise, several large tumor-specific cohort studies exist that do not specifically address unique AYA age-specific issues. Globally, so far, the identification of AYA patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed. The role of sociodemographic and treatment-associated risks, external exposures (e.g. lifestyle) and host factors (e.g. genetic); or combinations of influences for impaired (age-specific) health outcomes, remains largely unknown. Understanding who is at risk and why, will support the development of evidence-based AYA prevention, treatment and supportive care programs and guidelines.
Objective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (health-related quality of life and late effects) among a population-based sample of AYA cancer survivors. Study design: Retrospective, population-based, observational cohort study.
Study population: AYA cancer survivors, diagnosed at age 18-39 years between 1999-2015, identified from the Netherlands Cancer Registry (NCR), and alive 5-20 year after diagnosis Main study parameters/endpoints: Health-related quality of life; late effects
Conditions: Quality of Life, Late Effect, Survivorship, Lifestyle, Cancer
Intervention / Treatment:
Location: Netherlands
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Pathological confirmed cancer diagnosis;
* Age 18 - 39 years at time of first cancer diagnosis;
* Provide written informed consent.
* Treated in an Academic hospital or Netherlands Cancer Institute | 29,127 |
Study Objectives
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.
Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
Conditions: Breast Cancer
Intervention / Treatment:
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* females between 18 and 75 years of age
* signed written informed consent
* willing to take part in the trial and to follow the instructions
* breast tumour, histologically documented
* patients who have undergone curative surgery
* patients for whom a 6-treatment course of adjuvant chemotherapy (3FEC100 + taxanes) and radiotherapy has been scheduled
* patients with HER2-negative cancer.
Exclusion Criteria:
* metastatic cancer
* other primary tumours
* disability preventing a proper understanding of the instructions for the trial
* chemotherapy strictly contra-indicated
* patients who are subject to a court protection, wardship or guardianship order
* uncontrolled hypertension
* family history of sudden death in a first-degree relative
* unstabilised heart disease
* current treatment with beta-blockers
* chronic or acute pulmonary disease associated with dyspnoea upon moderate effort
* uncontrolled thyroid dysfunction
* uncontrolled diabetes
* any other serious conditions that are unstabilised, disabling or in which physical exercise is contra-indicated
* unable to attend for follow-up throughout the duration of the study
* ventricular ejection fraction (vef) \< 50%, pregnancy or suckling. | 11,534 |
Study Objectives
In this study, participants with esophageal squamous cell carcinoma will receive preoperative chemoradiotherapy with paclitaxel,carboplatin and pembrolizumab then undergo surgery. The primary study hypothesis is that adding pembrolizumab will increase complete pathologic response rate at surgery.
Conditions: Esophageal Squamous Cell Carcinoma
Intervention / Treatment:
DRUG: MK-3475(pembrolizumab)
Location: Korea, Republic of
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 ESCC
2. Clinical stage T1N1-2 or T2-34aN0-12 (AJCC 7 TNM classification)
3. No evidence of metastasis
4. Be willing and able to provide written informed consent/assent for the trial.
5. Be 20 years of age on day of signing informed consent.
6. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
7. Have a performance status of 0 or 1 on the ECOG Performance Scale.
8. Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
9. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
10. Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after the last dose of study medication.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
11. Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
3. Has a known history of active TB (Bacillus Tuberculosis)
4. Hypersensitivity to pembrolizumab or any of its excipients.
5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
7. Has another malignancy within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative surgery, or in situ cervical cancer.
8. Has active autoimmune disease that has required systemic treatment in the 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.
9. Has known history of, or any evidence of active, non-infectious pneumonitis.
10. Has an active infection requiring systemic therapy.
11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
12. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
13. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
16. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
17. Has received a live vaccine within 30 days of planned start of study therapy. | 32,606 |
Study Objectives
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of obrindatamab administered in combination with retifanlimab in patients with B7-H3- expressing tumors.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
BIOLOGICAL: obrindatamab, BIOLOGICAL: retifanlimab
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-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy ≥ 12 weeks
* Measurable disease, with the exception of prostate cancer
* Tissue specimen available for B7-H3 and PD-L1 expression testing
* Acceptable laboratory parameters
* Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to ≤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.
Exclusion Criteria:
* Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment:
1. No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids \>10 mg prednisone/day or equivalent)
2. No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases
3. No concurrent leptomeningeal disease or cord compression
* Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing
* Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration
* Treatment with any systemic chemotherapy within 3 weeks
* Treatment with radiation therapy within 2 weeks
* History of allogeneic bone marrow, stem-cell, or solid organ transplant
* Treatment with systemic corticosteroids (\> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks
* Clinically significant cardiovascular or pulmonary disease
* Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.
* Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
* Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction | 33,763 |
Study Objectives
RATIONALE: Finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. It is not yet known which communication method is more effective in increasing how often participants undergo colorectal cancer screening.
PURPOSE: This randomized clinical trial is studying traditional print communication methods to see how well they work compared with simple electronic communication methods or usual care in increasing how often older women undergo colorectal cancer screening.
Conditions: Colorectal Cancer
Intervention / Treatment:
OTHER: educational intervention via internet, OTHER: educational intervention mailed, OTHER: No additional educational intervention
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS:
* At average risk for colorectal cancer (CRC) as defined by the following criteria:
* Asymptomatic without a personal history of colorectal polyps or cancer
* No inflammatory bowel disease
* No family history of familial adenomatous polyposis or hereditary nonpolyposis CRC
* No CRC in more than one first-degree relative
* Nonadherent with standard CRC screening recommendations at the time of index OB/Gyn appointment
PATIENT CHARACTERISTICS:
* Email accessible at home and/or work
* Able to communicate with ease in English
PRIOR CONCURRENT THERAPY:
* Not specified | 26,557 |
Study Objectives
In breast cancer patients late-term upper limb sequelae, such as shoulder pain and impaired shoulder function remain common after primary breast cancer surgery. The aim of this trial is to evaluate whether an expert assessment of shoulder impairments, followed by an individualised treatment plan, is superior to a minimal physiotherapeutic rehabilitation program in reducing shoulder symptoms, assessed 12 weeks after initiation of treatment, among women with late-term shoulder impairments after primary breast cancer surgery.
Conditions: Shoulder Pain, Late Effect, Breast Cancer, Rehabilitation
Intervention / Treatment:
OTHER: The expert assessment of shoulder impairments and individualised treatment plan, OTHER: A minimal physiotherapeutic rehabilitation program delivered in a pamphlet
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
1. Breast cancer patients who underwent unilateral BCS or mastectomy on the left or right side, including SLND or +/- ALND within the last 3-7 years (2015-2019)
2. Currently living in the Region of Southern Denmark or Central Denmark Region with a radius of 75 km from Vejle Hospital
3. Between 18 and 71 age on time of surgery for primary breast cancer
4. Indicate pain in chest and/or shoulder area (shoulder impairments) as the biggest problem/late-term effect in everyday life
5. Indicate impaired shoulder function due to pain or due to tightness/tension
6. Indicate shoulder pain at rest, during general activities, during sleep or during flexion, rotation or abduction of the shoulder
7. A score ≥15 on the Disabilities of the Arm, Shoulder and Hand (Quick DASH)
8. Agree to participate in this trial and signs written informed consent
Exclusion Criteria:
1. No previous breast cancer (before 2014)
2. Cancer relapse after the date of index surgery, cancer spread outside of thorax and axilla, tumor fixed to chest wall
3. Primary- or secondary breast reconstruction performed at any time
4. Severe lymphedema (an average score ≥ 70% in the first 7 questionnaires on the LYMPH-ICF-DK
5. Bilateral breast cancer surgery
6. Previous surgery in the affected shoulder (prior to inclusion)
7. Previous shoulder or upper limb fractures (left/right)
8. Currently receiving chemo, immuno- or radiotherapy
9. Co-morbidity expected to influence shoulder function (e.g. rheumatoid arthritis, previous stroke, multiple sclerosis)
10. Other reasons for exclusion (e.g. pregnancy, not legally competent, unable to comprehend the information or unable to consent) | 37,065 |
Study Objectives
Endobronchial lung cancer tend to manifest in three different patterns. It can present as a bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from peribronchial disease. Bronchoscopy with differents techniques as forceps biopsy, bronchial brushing and bronchial washing is recognized as the gold standard to diagnose central airways lung neoplasms. Some authors suggested that the addition of endobronchial needle aspiration (EBNA) to these conventional diagnostic methods may increase the sensitivity of bronchoscopy in submucosal and peribronchial disease but few prospective trials have been performed and this procedure is still underutilized in many centers. Rapid on-site evaluation (ROSE) showed to improve yield of transbronchial needle aspiration (TBNA) of mediastinal nodes and pulmonary peripheral lesions, reducing the number of inadequate specimens and costs. However, its utility during endobronchial needle aspiration has not been substantiated.
This prospective study has two primary objectives: to compare the sensitivity of ROSE-EBNA with that of the conventional technique and to investigate the diagnostic yield of endobronchial needle aspiration and its contribution to CDM in the evaluation of patients with endobronchial lesions.
Conditions: Lung Cancer
Intervention / Treatment:
PROCEDURE: EBNA with ROSE, PROCEDURE: standard EBNA
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* consecutive adult patients with a suspected central lung cancer at a chest CT scan who need a bronchoscopy for diagnostic purposes
Exclusion Criteria:
* presence of uncontrolled coagulopathy, preexisting known malignancies, and the refusal to sign an informed consent | 161 |
Study Objectives
The proposed study is an open-label, single institution, single arm phase 1b study of neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.
Conditions: Locally Advanced Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: Cabozantinib, DRUG: Nivolumab
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:
1. Must have locally advanced/borderline resectable hepatocellular carcinoma.
2. Must have measurable disease.
3. Age ≥18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
6. Patients must have adequate liver remnant and function.
7. Antiviral therapy per local standard of care for hepatitis B.
8. Woman of child bearing potential must have a negative pregnancy test.
9. Must use acceptable form of birth control while on study.
10. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
1. Fibrolamellar carcinoma or mixed HCC.
2. Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months prior to trial registration.
3. Concomitant Anticoagulation therapy.
4. Any GI or pulmonary risks of bleeding.
5. History of HIV Infection.
6. Active co-infection with hepatitis B and hepatitis C.
7. Active co-infection with hepatitis B and hepatitis D.
8. Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.
9. History of any autoimmune disease requiring systemic treatment within the past 2 years. Any patient bearing an allograft is not eligible.
10. Any additional malignancies with treatment or life-limiting cancers. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial.
11. Uncontrolled intercurrent illness.
12. Corrected QT interval calculated by the Fridericia formula.
13. Uncontrolled high blood pressure.
14. Are pregnant or breastfeeding.
15. Any gastrointestinal (GI) disorders.
16. Any certain study-specified heart conditions 6 months prior to enrollment.
17. Major surgery within 2 months before enrollment.
18. Have any evidence of moderate or severe ascites.
19. Any untreated or incompletely treated varices with bleeding or high-risk bleeding.
20. Inability to swallow intact tablets.
21. Known or suspected hypersensitivity to study treatment. | 5,675 |
Study Objectives
This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.
Conditions: Metastatic Breast Cancer, Neoplasms, Breast
Intervention / Treatment:
DRUG: Lapatinib, DRUG: capecitabine
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria:
* Subjects eligible for enrolment in the study must meet all of the following criteria:
* Patients who have consent to this study participation and signed into Informed consent form.
* Subjects must have histologically confirmed invasive breast cancer with stage IIIB, stage IIIC with T4 lesion, or stage IV disease.
* Documentation of ErbB2 overexpression \[IHC3+ or IHC2+ with FISH confirmation\] is required based on local laboratory.
* Subjects must have documented progressive advanced or metastatic breast cancer.
* Subjects must have refractory breast cancer defined as progression in the locally advanced or metastatic setting or relapse within 6 months of completing adjuvant therapy. Prior therapies must include, but are not limited to:
* Taxane containing regimen for at least 4 cycles or 2 cycles provided disease progression occurred while on taxane.
* Anthracycline containing regimen for at least 4 cycles or 2 cycles provided disease progression occurred while on anthracycline.
* Subjects who relapse \>6 months after completion of adjuvant anthracycline-containing chemotherapy, and for whom further anthracycline is not indicated, will be considered to have met the anthracycline prior exposure requirement.
* Taxanes and anthracyclines may have been administered concurrently or separately.
* Prior treatment with capecitabine is not permitted.
* Prior treatment must have contained trastuzumab alone or in combination with other chemotherapy for at least 6 weeks of standard doses in the adjuvant or advanced/metastatic setting.
* Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.
* Subjects with stable CNS metastases (asymptomatic, and off systemic steroids and anticonvulsants for at least 3 months) are eligible.
* Measurable disease according to modified RECIST (Response Evaluation Criteria in Solid Tumors) (see Section 6.2, Efficacy p.49).
* Subjects must have archived tumor tissue available for biomarker assessment.
* Female subjects must be ≥20
* ECOG Performance Status of 0 or 1.
* Life expectancy of ≥12 weeks.
* Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.
* Cardiac ejection fraction within the institutional range of normal as measured by ECHO (or MUGA if ECHO is not available). If no institutional range is available, cardiac ejection fraction must be ≥50%.
* Adequate hematologic value, hepatic and renal function as defined below. Hematologic ANC (absolute neutrophil count) ≥1.5×109/L Hemoglobin ≥9 g/dL Platelets ≥100× 109/L Hepatic Serum bilirubin ≤1.5×ULN
* 2.5×ULN if subject has Gilbert's syndrome AST and ALT ≤5×ULN if documented liver metastases
* 3×ULN without liver metastases Renal Serum creatinine Creatinine clearance\* ≤50 mL/min
* Calculated by the Cockcroft and Gault Method
Exclusion criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
* Pregnant or lactating females.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. In addition, subjects with ulcerative colitis are excluded.
* History of other malignancy. Subjects who have been disease-free for at least 5 years or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior anticancer therapy.
* Active or uncontrolled infection.
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
* Known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart failure.
* No prior anti-ErbB1/ErbB2 inhibitor for breast cancer other than trastuzumab.
* Known history or clinical evidence of leptomeningeal carcinomatosis.
* Concurrent anticancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine.
* Bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of study medication. Prophylactic use of bisphosphonate in subjects without bone disease is not permitted, except for prevention of osteoporosis.
* Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
* Participation in other studies or use of other investigational drugs during this study.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients of lapatinib.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Patients who an investigator judges ineligible to this study in consideration of patient's safety (e.g., complications). | 6,873 |
Study Objectives
Immune therapy represents a promising option for the treatment of an increasing number of malignancies. New immunotherapeutic strategies are currently under development and will be further studied starting from refractory settings of heavily pre-treated mCRC patients. On this basis, a specific immunological characterization of CRC metastasis will be relevant to direct future clinical and pharmacological research.
As surgery is a therapeutic option in the treatment of mCRC, a percentage of mCRC patients undergo to resection of metastasis before or after medical treatment. These tumour samples could be useful to define the immune signature of colorectal metastatic disease.
On the basis of the above reported considerations, an exploratory, prospective, observational study for the immunophenotypical characterization of colorectal cancer metastasis from pre-treated vs chemo-naive patients has been planned.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
Location: Italy
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Histological diagnosis of colorectal cancer
* Metastatic disease
* Surgery for metastatic disease
* Availability of clinical data
Exclusion Criteria:
* Non-metastatic disease | 9,692 |
Study Objectives
This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.
Conditions: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
Intervention / Treatment:
DRUG: Nilotinib
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Diagnosed as Ph+ ALL who are either relapsed after or refractory to standard therapy
* Diagnosed as CML in blast crisis or accelerated phase or chronic phase who are resistant or intolerant to imatinib
* Performance status is normal or ambulatory and capable of all self-care Exclusion Criteria
* A history of significant or serious uncontrolled cardiovascular disease
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib
* Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
Exclusion Criteria:
* Cytopathologically confirmed CNS infiltration NB: in absence of suspicion of CNS involvement, lumbar puncture is not required
* Impaired cardiac function, including any one of the following
* LVEF \< 45% as determined by echocardiogram
* Complete left bundle branch block
* Use of a cardiac pacemaker
* ST depression of \> 1mm in 2 or more leads and/or T-wave inversions in 2 or more contiguous leads
* Congenital long QT syndrome
* History of or presence of significant ventricular or atrial tachyarrhythmias
* Clinically significant resting bradycardia (\< 50 beats per minute)
* QTc \> 480 msec on screening ECG (using the QTcF formula)
* Right bundle branch block plus left anterior hemiblock, bifascicular block
* Myocardial infarction within 3 months prior to starting AMN107
* Uncontrolled angina pectoris
* Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107 (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
* Use of therapeutic warfarin
* Acute or chronic liver or renal disease considered unrelated to tumor (e.g., hepatitis, cirrhosis, renal insufficiency, etc.)
* Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
* Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF) ≤ 1 week prior to starting study drug.
* Patients who are currently receiving treatment with any of the medications listed in (cf. Post-text suppl. 5) that cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in (cf. Post-text suppl. 5) have the potential to prolong the Q-T interval.
* Patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose chemotherapy (6 weeks for nitrosurea or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy. Hydroxyurea is permitted at the investigator's discretion prior to enrollment.
* Patients who have received Glivec® ≤ 1 week or who have not recovered from side effects of such therapy.
* Patients who have received immunotherapy ≤ 1 week prior to starting study drug or who have not recovered from side effects of such therapy.
* Patients who have received any investigational drug (excluding STI571/Glivec) ≤ 4 weeks or investigational cytotoxic agent within 1 week (or who are within 5 half-lives of a previous investigational cytotoxic agent) prior to starting study drug or who have not recovered from side effects of such therapy.
* Patients who have received wide field radiotherapy ≤ 4 week or limited field radiation for palliation ≤ 2 week prior to starting study drug or who have not recovered from side effects of such therapy.
* Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
* Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of AMN107). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
* Patients unwilling or unable to comply with the protocol
Other protocol-defined inclusion and exclusion criteria may apply. | 40,757 |
Study Objectives
The purpose of this study is to investigate the efficacy of mechanical stimulation on mastectomy scars in:
(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
Conditions: Breast Cancer
Intervention / Treatment:
OTHER: Mechanical stimulation (LPG system; Cellu M6 Integral I), OTHER: Conventional treatment
Location: Hong Kong
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Women aged 18 years old or above with mastectomy performed in recent 6 weeks;
* Able to attend physiotherapy treatment and follow-ups during the study period.
Exclusion Criteria:
* Altered mental state for cooperation and informed consent;
* Signs and symptoms of mastectomy scar infections or inflammations;
* Unhealed mastectomy wounds;
* History of lymphoedema;
* Diagnosed bilateral breast cancers;
* Unstable medical or cardiovascular conditions;
* Pre-existing arm impairments/dysfunctions that will affect testing or exercising the affected arm;
* Receiving radiotherapy during the study period;
* Known sensitivity to mechanical stimulation;
* Skin cancer on the treatment area;
* Unclear cut margins of the cancer;
* Known metastasis to other areas;
* HIV positive. | 13,417 |
Study Objectives
Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST).
Conditions: Germ Cell Tumor, Yolk Sac Tumor
Intervention / Treatment:
DRUG: sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. The child must have histological evidence of an extracranial malignant germ cell tumor (vitelline sac tumor).
2. Children must be no more than 14 years old at the time of study participation.
3. The child must be resistant to at least two platinum-containing chemotherapy regiments or have relapse within 3 months of chemotherapy.
4. The child must have measurable lesions (recorded according to RECIST criteria) or non-evaluable disease with tumor marker AFP greater than 5 times the upper limit of normal.
5. Lansky performance status score ≥50.
6. The life expectancy of the child must exceed 6 weeks.
7. The child must have recovered from the response to all previous anticancer treatments.
8. No serious organ dysfunction: normal cardiac function (ejection fraction \> 50% or BNP \< 2000pg/ml); Liver function: alanine aminotransferase increased less than 5 times the upper limit of normal, bilirubin increased less than 3 times the upper limit of normal; Renal function: creatinine and urea nitrogen levels below the normal range; The white blood cells were greater than 3×109/L, and the platelets were greater than 100×109/L.
9. Obtain the informed consent of the guardian and sign the informed consent.
Exclusion Criteria:
1. Patients with other tumors.
2. Heart, brain, liver, kidney and other organ failure patients. | 43,573 |
Study Objectives
Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Zoledronic acid, DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;
Exclusion Criteria:
Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).
Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).
Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.
Other protocol-defined exclusion criteria may have applied. | 11,653 |
Study Objectives
The current standard for locally advanced cervical cancer is concurrent cisplatin-based chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and chemotherapy effects.
Objective. To determine response rate, safety and biological effects of hydralazine and magnesium valproate when added to cisplatin chemoradiation.
Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase the clinical complete response rate to 95% as compared to 75% as seen in historical controls treated with cisplatin chemoradiation in FIGO stage IIIB patients.
Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical carcinoma with no previous treatment will be included. Patients will be typed for acetylator status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at 40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical response rate, safety and transcriptome changes will be analyzed.
Conditions: Cervical Cancer
Intervention / Treatment:
DRUG: Hydralazine and magnesium valproate, PROCEDURE: Punch biopsy of the primary tumor
Location: Mexico
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* informed consent, histological diagnosis of cervical carcinoma (epidermoid, adenoesquamous and adenocarcinoma), clinical stage III B, untreated, aged 18-70 years, performance status 0-2 according to ECOG classification, and adequate liver, hematological and renal function, as defined by: hemoglobin \>10 g/L, leukocytes \>4000/mm3, platelets \>100 000mm3; normal creatinine value and creatinine clearance \>60 mL/min; total bilirubin \< 1.5 upper normal limit value; no evidence of systemic disease or para-aortic lymph node involvement.
Exclusion Criteria:
* History of allergy to hydralazine or valproate; past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding. Other exclusion criteria included uncontrolled systemic disease or infection. | 1,021 |
Study Objectives
Background
Hepatic intra-arterial chemoembolization (TACE) is proposed when potentially curative therapy (eg. surgical resection, percutaneous ablation)is no longer possible. Prospective and non-randomized retrospective studies showed TACE to be capable to increase survival vs controls. In 2002 the first results of two RCTs were published which had been conducted on unresectable HCC patients, designed to assess the impact produced by TACE on survival, demonstrated a statistically significant advantage in TACE treated patients compared to controls. The same results have been confirmed by a meta-analysis conducted on 14 trials published in literature. The limitations of TACE are represented however by the difficulties in obtaining a complete necrosis of the lesion treated and for this reason new embolization agents are being developed to increase the efficacy of TACE in HCC as the microsphere, in poly vinyl alcohol and co-acrylic acid that are not reabsorbable and induce permanent embolization. The first experimental studies using microsphere showed the good tolerability and the higher rate of tumor necrosis, but no RCTs have been conducted to investigate their impact on survival. Objectives. The primary aim of this study is to compare 2 years survival of patients randomized to selective traditional TACE or selective TACE via microspheres loaded with Doxorubicin. Secondary objectives investigate the time to progression of disease (radiologic and symptomatic) by radiologic, laboratory tests and the QoL questionnaire administration. Methods. This is a multicentre, randomized, open-label, active controlled study in HCC patients treated with standard TACE vs TACE with doxorubicin - loaded microsphere. The study comprises a selection period, a treatment period and a follow up phase with a total duration of 2 years from randomization. Expected results. The sample size(alfa 5%, power 80%) is adequate to detect a 20% difference between TACE with microsphere vs traditional TACE.
Conditions: Carcinoma, Hepatocellular
Intervention / Treatment:
PROCEDURE: Selective TACE via microsphere loaded with Doxorubicin, PROCEDURE: Selective traditional TACE
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Diagnosis of HCC: based on the Guidelines issued by AASLD (American Association for the Study of Liver Diseases) (latest diagnostic radiological imaging performed within 1 month from enrolment)
* HCC for which transplantation, surgical resection or percutaneous ablation are not indicated
* Absence of extrahepatic cancer involvement
* Absence of portal vein thrombosis, with the exception of thrombosis of a segment branch of the portal vein
* Child-Pugh class A or B
* Performance status: ECOG 0-2 (WHO)
* Target liver lesion measurable as per WHO modified EASL criteria
* Life expectancy of at least 3 months in absence of treatments.
* Prior surgical or locoregional ablation or TACE treatments are allowed for lesions other than the target lesion treated and monitored to define tumor response.
* The following laboratory parameters must be met:
Creatinine ≤ 1.50 mg/dL, Bilirubin ≤ 2.5 mg/dL, Albumin \>= 30 g/L White blood cells \>= 1.5 x 109/L, PLT \>= 50 x 109/L, PT \>= 50%
* Signature of informed consent obtained.
Exclusion Criteria:
* Infiltrative HCC
* Liver tumor is undefined, unmeasurable or not assessable
* Occlusive thrombosis of the common portal trunk or of a main branch (right or left).
* Ascites, F3-type varices.
* Contraindications to arteriography
* Hepatofugal portal flow
* Presence of hemodynamically relevant abnormalities of hepatic arterial structure, such as not to allow for a correct and safe delivery of microspheres.
* Prior TACE to the target lesions
* Presence of chronic or acute co-morbidities (to lungs, heart, kidneys or brain) because of which the patient is not eligible to receive the treatment foreseen by the protocol.
* Prior neoplasias in the 5 preceding years or concomitance of other neoplasias at enrolment, wtih the exception of cutaneous basal cell or squamous cells carcinoma or carcinoma in situ of the uterine cervix
* Presence of localized or systemic infections (with the exception of HIV infecton responsive to therapy).
* Pregnant women (women of child-bearing potential will have a pregnancy test done) and breastfeeding women;
* Known or suspect hypersensitivity to the investigational drug or to the investigational pharmacological class;
* Patients presenting with severe clinical conditions which in the opinion of the investigator contraindicate patient participation in the study;
* Use of investigational drugs in the last month prior to inclusion into the study
* Patients who are not capable of complying with the procedures established by the protocol and of signing the informed consent. In case of minors or incapacitated patients unable to release their informed consent to take part in the study, the consent must be released and signed also by the parents/guardian or by the legal representative. Minors or incapacitated patients must as well sign the informed consent to the best of their ability. | 19,457 |
Study Objectives
The long-term goal of this research is to increase breast cancer screening rates in NYC Chinese immigrants. The researchers plan to accomplish this objective by developing and testing a culturally- and linguistically-adapted Witness Project program for Chinese immigrants. To inform the intervention development, the study team will identify barriers and facilitators to breast cancer screening in Chinese immigrants through individual qualitative interviews.
A total of 156 participants will be recruited during the entire study.
In Aim 1 which started in July 2021, 60 women were recruited for in-depth interviews to assess their breast cancer knowledge, perceived barriers and benefits/risks to completing mammography, perceived susceptibility to breast cancer, fatalism, screening intention, acculturation, language preference, and health literacy.
In Aim 2, 96 women will be recruited to participate in the pilot testing of the intervention. Recruitment will take place at community sites that serve Chinese immigrants in New York City. Enrollment for Aim 2 is anticipated to start in March of 2022.
Conditions: Screening Mammogram
Intervention / Treatment:
BEHAVIORAL: Narrative breast health education
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* ≥ 40 years of age
* female
* born in China
* read and speak Cantonese, Mandarin, or English
Exclusion Criteria:
- none | 23,939 |
Study Objectives
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
Conditions: Leukemia, Myeloid, Acute
Intervention / Treatment:
DRUG: Placebo, DRUG: Volasertib, DRUG: Cytarabine
Location: Argentina, Taiwan, Korea, Republic of, South Africa, Portugal, India, Austria, Norway, Greece, Spain, France, Czechia, Mexico, Netherlands, Hungary, Germany, United States, Canada, Russian Federation, Italy, Finland, Poland, Belgium, Japan, Brazil
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion criteria:
1. Age \>= 65years.
2. Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
3. Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed.
4. Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions).
5. Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
6. Eastern co-operative oncology group (ECOG) performance score \<= 2 at screening.
7. Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.
Exclusion criteria:
1. Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed.
2. Treatment with any investigational drug within 2 weeks before first administration of present trial drug.
3. Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3).
4. Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukaemic CNS involvement (no lumbar puncture required, clinical assessment per investigator´s judgement is sufficient).
5. Hypersensitivity to one of the trial drugs or the excipients.
6. Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC.
7. Corrected QT interval according to Fridericia (QTcF) prolongation \> 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
8. Total bilirubin \> 3 x upper limit of normal (ULN).
9. Creatinine clearance (CLcr) \< 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
10. Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.
11. HIV infection.
12. Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
13. Any significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s safety or compliance, interfere with consent, study participation, or interpretation of study results.
14. Known or suspected active alcohol or drug abuse.
15. Patient unable to comply with the protocol, in the opinion of the investigator.
16. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment. | 3,943 |
Study Objectives
Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage is used routinely to reduce incidence of seroma. Usually two drains are used in patients who underwent MRM to reduce post operative seroma. It is often associated with significant patient discomfort and prolonged fluid drainage.
The aim of this study is to evaluate effect of number of drains on seroma formation rate, postoperative pain and hospital stay during the immediate postoperative period after mastectomy for breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DEVICE: Drain
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* All female patients underwent MRM for biopsy proven carcinoma breast
Exclusion Criteria:
* Immediate reconstruction
* Patient refusal to participate in study | 1,585 |
Study Objectives
Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer: diagnostic performance and impact on the patient management.Determine the lowest cost strategy according to the precise clinical circumstances.
Conditions: Prostate Cancer
Intervention / Treatment:
DEVICE: performance of PET/CT and whole-body MRI
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Age \> 18
* Histologically proven prostate cancer.
* Abnormal plasmatic level of prostate specific antigen dating less than 3 months, initial Gleason score available
* Written informed consent.
Exclusion Criteria:
* Other active cancer or bone infection.
* Chemotherapy or change in hormone therapy since the last PSA assay
* Contraindication to MRI without contrast agent (claustrophobia, pace maker, metallic foreign body, some cardiac valves). Metallic joint prostheses are NOT a contraindication.
* Allergic reaction to radiopharmaceuticals that will be used.
* Patient who seems not capable of staying in the gantry of the machines during the examinations without moving. | 26,531 |
Study Objectives
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
Conditions: Breast Cancer
Intervention / Treatment:
DEVICE: GeneSearch™ Breast Lymph Node (BLN) Assay
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Previous diagnosis of carcinoma of the breast
* Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
* 18 years or older
* Female or male, and
* Able and willing to give consent to participate in the study
Exclusion Criteria:
* Patients taking part in other research studies that would interfere with their full participation in this study | 35,920 |
Study Objectives
In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: IM-SLNB, RADIATION: 99mTc-SC, DEVICE: Histologic Examination, DEVICE: LSG, DRUG: Methylthioninium
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* primary breast cancer
* clinically axilla-positive
Exclusion Criteria:
* enlarged internal mammary nodes by imaging | 14,541 |
Study Objectives
There are various techniques to obtain tissue samples by using fine needle guided by endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material with the best quantity and quality for analysis. Currently studies that compare the results concerning capillary technique versus wet technique are not available. In this sense, the authors consider necessary to explore both techniques documenting the results that can define which could be the best method so that it can routinely be used in cases of digestive neoplasia.
Conditions: Digestive Cancer
Intervention / Treatment:
PROCEDURE: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Location: Mexico
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Low or moderate suspicious of malignancy lesion in pancreas, liver or metastatic lymph nodes
* Initial diagnosis according to the characterization by endoscopic ultrasound
Exclusion Criteria:
* Bleeding
* Complications during biopsy procedure
* Needed to use procedures other than those contemplated in the study.
* Patients who not require endoscopic ultrasound evaluation
* Patients who not accept the procedures of the study | 40,994 |
Study Objectives
The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab.
A standard anonymous data collection form will be used to collect data and to analyze it.
Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Nivolumab 10 MG/ML
Location: Spain
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP)
2. Alive patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care
Exclusion Criteria:
1. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form
2. Patients who were accepted in the EAP but do not receive treatment | 44,974 |
Study Objectives
Stem cell transplantation may be used to cure childhood cancers, and other diseases. Traditionally, stem cell transplants use high doses of chemotherapy and radiation. This regimen may cause significant problems after transplant such as infertility, infection, and graft versus host disease (GVHD).
Reduced intensity transplant (RIT) uses medications which weaken the immune system, allowing donor cells to take over. The goal of a RIT is to reduce the risk for complications after transplant. Usually medication is used to weaken the immune system, but there are other options such as extracorporeal photopheresis (ECP) that may be less toxic.
ECP is currently used for the treatment of GVHD and certain lymphomas. ECP uses a machine that filters white blood cells from the blood, treats them with ultraviolet (UV) light, and then gives all the cells back to the patient. The patient's immune system becomes weaker, allowing the donor cells to replace those of the patient. Studies involving the use of ECP for conditioning have shown fewer side effects than the use of medications.
The primary purpose of this clinical research trial is to evaluate the safety and feasibility of ECP as part of a preparative regimen for RIT in children and young adults.
Conditions: Leukemia, Cancer
Intervention / Treatment:
PROCEDURE: Extracorporeal Photopheresis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Weight \> 25 kg
* Patients with acute lymphoblastic leukemia (ALL) who are in CR (complete remission; \< 5% blasts in bone marrow and no active central nervous system disease) who:
* Are in second remission with an initial remission of \< 36 months.
* Patients with "high risk" disease in CR1, defined by karyotype abnormalities such as presence of (9;22) translocation, monosomy 7, or monosomy 5; and/or patients with slow initial response (initial remission not reached within four weeks from diagnosis).
* Are in third (or subsequent) remission
* Experience isolated extramedullary relapse while on therapy
* Have experienced relapse following myeloablative stem cell transplant
* Are WT1+ following induction therapy
* Patients with acute myelogenous leukemia (AML) who:
* Are in first remission and remain WT1 positive.
* Are in second remission
* Are in initial partial remission (\< 20% blasts in bone marrow)
* Experience relapse following myeloablative stem cell transplant
* Patients with relapsed lymphoma whose residual disease appears to be chemo-responsive and non-bulky (\< 5 cm largest diameter)
* Patients with chronic myelogenous leukemia (CML) in chronic phase who:
* Don't achieve remission (molecular or cytogenetic) by 1 year of diagnosis with therapy (imatinib mesylate or interferon)
* Have a rising quantitative bcr/abl on imatinib mesylate (molecular relapse)
* Had developed accelerated phase regardless of therapy but are now back in second chronic phase
* Patients with recurrent solid tumors (neuroblastoma, Ewing's sarcoma, melanoma, rhabdomyosarcoma)
* Patients with myelodysplastic syndrome
* Patients with refractory anemia (RA) and refractory anemia with excess blasts (RAEB) are eligible, but refractory anemia with excess blasts in transformation (RAEB-T) patients are only eligible if treated to \< 20% blasts with chemotherapy
* Patients with selected immunodeficiencies such as Wiskott-Aldrich syndrome or hyper-IgM syndrome
* Patients with metabolic diseases such as Niemann-Pick or adrenoleukodystrophy
* Patients with bone marrow failure syndromes, including aplastic anemia
* Adequate venous access | 17,159 |
Study Objectives
Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
Conditions: Malignant Glioma, Astrocytoma, Glioblastoma
Intervention / Treatment:
DRUG: nivolumab, BIOLOGICAL: DC
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Age 18-80 years of age
* First or second recurrence of MG (WHO Grade III or IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of MG
* Bevacizumab-naïve - no prior exposure to Bevacizumab
* Karnofsky Performance Status (KPS) of ≥ 70%
* Radiation Therapy (RT) with ≥ 45 Gray (Gy) tumor dose, completed ≥ 8 weeks prior to study entry
* Laboratory values must meet the following criteria:
1. White Blood Count (WBC) ≥ 2000/microliters (uL)
2. Neutrophils ≥ 1500/uL
3. Platelets ≥ 100x103/uL
4. Hemoglobin ≥ 9.0 g/dL
5. Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min (using the Cockcroft-Gault formula) c. Female CrCl = (140 - age in years) x weight in kg x 0.85 /72 x serum creatinine in mg/dL d. Male CrCl = (140 - age in years) x weight in kg x 1.00/72 x serum creatinine in mg/dL
6. Aspartate Aminotransferase (AST) ≤ 3x ULN
7. Alanine Aminotransferase (ALT) ≤ 3x ULN
8. Bilirubin≤ 1.5x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
9. Subjects must have resting baseline O2 saturation by pulse oximetry of ≥ 92% at rest.
* Patients of child bearing potential or with partners of child-bearing potential must practice recommended contraceptive methods to prevent pregnancy during treatment and for 5 months after the last dose of nivolumab for women, 7 months after the last dose of nivolumab for men, and for 6 months after the last dose of bevacizumab for subjects receiving bevacizumab.
Exclusion Criteria:
* Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)
* Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
* Pregnant or need to breast feed during the study period (Negative human chorionic gonadotropin (β-HCG) test required), or unable to maintain use of contraception while on study and for 31 weeks after the last dose of nivolumab
* Active infection requiring treatment or an unexplained febrile (\> 101.5o F) illness
* Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C
* Known allergy or hypersensitivity to tetanus, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine (i.e., aluminum phosphate, formaldehyde)
* Known severe (Grade 3 or 4) infusion-related allergy or hypersensitivity to any monoclonal antibody
* Previous radiation therapy with anything other than standard radiation therapy (such as previous stereotactic radiosurgery) or previous treatment with an immune checkpoint inhibitor (i.e., nivolumab, pembrolizumab, ipilimumab)
* Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 \< 50%) disease, uncontrolled diabetes mellitus
* Corticosteroid use \> 4 mg/day at time of consent
* Prior inguinal lymph node dissection. | 23,483 |
Study Objectives
Background:
B-cell lymphoma is a cancer of white blood cells that are found in lymph nodes. Some kinds of these cancers, such as gray-zone and extra-nodal, are rare and often aggressive. They are usually resistant to current treatments. Researchers want to see if a drug called pembrolizumab may treat these types of lymphoma.
Objective:
To collect data to see if it may be effective to give pembrolizumab to people with certain types of rare, aggressive B-cell lymphomas.
Eligibility:
People ages 18 and older who have a B-cell lymphoma, including gray-zone lymphoma or extra-nodal lymphoma
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Scans. They will lie in a machine that takes images.
A tissue sample from a previous procedure will be tested.
The study will be done in 21-day cycles. During the study, participants:
Will repeat the screening tests.
Will get the study drug as an infusion into a vein over about 30 minutes.
Will have a cheek swab and/or saliva sample collected.
May have a bone marrow aspiration. A needle will be put into the hipbone, and a small amount of bone marrow will be taken out.
May have a lumbar puncture. If cerebrospinal fluid is collected, researchers will study it.
May have an eye exam.
May provide tissue samples.
May have tumor samples taken.
Participants will have a visit about 30 days after the last dose of the study drug. They will then have 4 visits in year 1, 2 visits a year in years 2-5, and once each year thereafter. They will also be contacted by phone.
Conditions: Non-Hodgkin Lymphoma, Lymphoma, Diffuse Large B-Cell Lymphoma, Gray-zone Lymphoma, Primary Central Nervous System Lymphoma
Intervention / Treatment:
BIOLOGICAL: Pembrolizumab
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 a diagnosis of B-cell lymphoma confirmed by Laboratory of Pathology, National Cancer Institute (NCI), that is relapsed from or refractory to prior therapy as follows:
* Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
* Cohort 2: Extranodal diffuse large B-cell lymphoma involving one or more of the specified extranodal sites (i.e., extranodal diffuse large B-cell lymphoma (DLBCL). The following subtypes are included (they do not have to be confirmed as non-germinal center (non-GCB) subtype for study entry):
* Primary central nervous system (CNS) lymphoma (PCNSL)
* Primary testicular lymphoma (PTL)
* Primary breast lymphoma (PBL)
* Primary cutaneous DLBCL, leg-type
* Intravascular large B-cell lymphoma (IVBCL)
* Diffuse large B-cell, not otherwise specified (NOS), activated B-cell type, involving 1 or more extranodal site
NOTE: For GZL, diagnosis will be in accordance with the 2016 World Health Organization classification of lymphoid malignancies. Patients diagnosed with other extranodal DLBCL subtypes or that are not otherwise specified (NOS) must involve at least 1 extranodal site and must be considered non-GCB by local immunohistochemistry algorithms. Cases that are non-GCB by the Hans criteria are considered eligible as well as cases of DLBCL that are both cluster of differentiation 10 positive (CD10+) and multiple myeloma 1 positive (MUM1+).
* Evaluable disease by clinical exam (i.e., palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e., lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and/or imaging (measurable lymph nodes or masses on computed tomography (CT) or magnetic resonance imaging (MRI) and/or evaluable fluorine-18-deoxyglucose (FDG)-avid lesions on positron emission tomography (PET)
* Adequate tumor tissue (archival or fresh) must be available for correlative studies. NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. If prior tissue is not available, patient must be willing to undergo baseline tumor biopsy.
* Be 18 years of age or older on day of signing informed consent
* Adequate performance status (PS) as follows:
* Patients greater than or equal to 18 years must have Eastern Cooperative Oncology Group (ECOG) 0-1 (and Karnofsky greater than or equal to 60%)
NOTE: Patients greater than or equal to 18 years with an ECOG PS of 2 and Karnofsky greater than or equal to 60 will be considered eligible at the discretion of the Principal Investigator if decreased ECOG performance status is felt to be related to residual neurologic deficits caused by CNS disease involvement that are not progressive or anticipated to cause clinical management problems during study participation.
- Adequate organ function as evidenced by the following laboratory parameters (unless related to lymphoma infiltration at the discretion of the investigator):
* Absolute neutrophil count (ANC) greater than or equal to 750 /mcL
* Platelets greater than or equal to 50,000/mcL (transfusions not permitted)
* Hemoglobin greater than or equal to 9 g/dL (transfusions permitted)
* Serum creatinine: Adults: less than or equal to 1.5 times upper limit of normal (ULN). Children: age greater than or equal to 14: less than or equal to 1.5 mg/dL OR measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl):
Greater than or equal to 30 mL/min/1.73 m(2) for subject with creatinine levels \> 1.5 times institutional ULN (CrCl should be calculated per institutional standard)
--Serum total bilirubin less than or equal to 1.5 times ULN
OR
Direct bilirubin less than or equal to ULN for patients with total bilirubin levels \> 1.5 ULN
* Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times ULN (less than or equal to 5 X ULN if liver involvement)
- The effects of pembrolizumab on the developing human fetus are unknown. For this reason, the following measures apply:
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose of pembrolizumab.
* Men and women of childbearing potential (WOCBP) who are sexually active must agree to adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 120 days after the last dose of pembrolizumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Participants must not be planning to conceive or father children within the projected duration of the trial, starting with the pre-screening/screening visit through 120 days after the last dose of pembrolizumab.
* WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.
* Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document
EXCLUSION CRITERIA:
* Patients with DLBCL who best fit the criteria of Epstein-Barr virus (EBV)+ DLBCL, NOS are not eligible
* Current or prior anti-cancer treatment prior to the first dose of pembrolizumab as defined below:
* Chemotherapy, targeted small molecule therapy, or other anti-cancer treatment not otherwise specified below within 2 weeks
* Radiation therapy within 2 weeks
* Anti-cancer monoclonal antibody (mAb) treatment within 4 weeks
* Use of an investigational agent (e.g., biologic, drug, or other) within 4 weeks
* Allogeneic stem cell transplant within 100 days
* Prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed death ligand 2 (PD-L2) agent at any time
* No current use of systemic corticosteroids at physiologic doses \> 10 mg/day of dexamethasone or equivalent are permitted. Patients receiving current systemic steroids must be on a stable steroid dose (i.e., less than or equal to 10 mg/day of dexamethasone or equivalent at the same dose for at least 7 days). Patients who recently discontinued systemic steroids must have completed them at least 7 days prior to entry.
* Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:
* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV):
---Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody \[HBcAb\] and negative HBsAg) may be included if HBV deoxyribonucleic acid (DNA) is undetectable.
* Uncontrolled and/or symptomatic thyroid disease
* Active graft-vs-host disease (GVHD) requiring treatment or any history of greater than or equal to grade II acute GVHD
* Seizure activity within the past 4 weeks
* Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.
* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding must be discontinued if the mother is treated with pembrolizumab
* Received a live vaccine within 30 days of planned start of study therapy. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab unless felt to be in the best interests of the patient in the opinion of the investigator
* Known additional malignancy that requires active systemic treatment | 2,612 |
Study Objectives
Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting for patients undergoing liver resection. This treatment is given either to keep the tumor at bay or reduce its size before the time of resection. While many metastatic tumors might appear to respond well and even radiographically disappear following neoadjuvant therapy, it is unclear whether grossly or radiographically negative areas of previous disease are microscopically free of tumor cells. As such, when possible, resection boarders typically follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be necessary to encompass all histologically present disease or they might be unnecessarily large, serving only to increase the mortality and morbidity of the operation. This study begins to address this question by a histological examination of the pattern of cell death in areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined to determine whether there is an increased rate of recurrence despite "negative" resection boundaries in these cases.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients must be ≥ 18 years old.
* Patients must have colon cancer metastases to the liver.
* Patients must be candidates and be scheduled for liver resection.
* Patients must have received and have had a response to neoadjuvant therapy prior to liver resection.
* Patients must have signed Institutional Review Board (IRB) approved written consent form prior to registering in the study.
Exclusion Criteria:
* Patients who are \< 18 years old.
* Patients who do not have colon cancer metastases to the liver.
* Patients who are not surgical candidates.
* Patients who do not schedule or who cancel a liver resection.
* Patients who have not received neoadjuvant therapy.
* Patients who have received neoadjuvant therapy but who have had no response or who have had tumor progression. | 23,897 |
Study Objectives
This research study is looking at kidney and blood pressure changes in patients receiving bevacizumab, aflibercept, sunitinib, or cediranib for cancer. Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment with an antiangiogenic drug.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
OTHER: laboratory biomarker analysis
Location: Canada
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Planning to start treatment with one of the following antiangiogenic drugs as single agents or in combination with chemotherapy for their cancer:
* Cediranib (AZD2171 )
* Bevacizumab (Avastin)
* Sunitinib (Sutent)
* Aflibercept (VEGF Trap)
* Urinalysis negative for protein OR 24-hour urine for protein \< 500 mg
* Prior chemotherapy within the past 12 months allowed
* More than 12 months since prior antiangiogenic drugs, including monoclonal antibodies that bind to VEGF or tyrosine kinase inhibitors that block VEGFR2
* At least 6 weeks since prior and no concurrent aldosterone receptor antagonists (e.g., spironolactone \[aldactone\] or eplerenone)
* No other concurrent investigational agents | 11,016 |
Study Objectives
The purpose of this study is to determine the safety and effectiveness of oral SCIO-469 in patients with myelodysplastic syndromes. SCIO-469 belongs to a new class of treatments that inhibit expression and activity of cytokines that play a role in the progression of MDS.
Conditions: Bone Marrow Diseases, Myelodysplastic Syndromes, Hematologic Diseases, Bone Marrow Neoplasms
Intervention / Treatment:
DRUG: SCIO-469, DRUG: SCIO-469, DRUG: SCIO-469, DRUG: SCIO-469
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patients with a diagnosis of low/intermediate-1 MDS (for at least 12 weeks)
* Patients with anemia (average Hemoglobin \< 10 g/dL or \> or = to 4 units of Red Blood Cell counts in the last 8 weeks)
* Patients who have failed prior erythropoietin treatment
* Patients with an ECOG (Eastern Collaborative Oncology Group) score of 0, 1 or 2
Exclusion Criteria:
* Patients with a International Prognostic Scoring System risk category high/intermediate-2
* Patients with treatment-related MDS associated with radiation, chemotherapy, and/or autologous transplant
* Patients with myelosclerosis (or myelofibrosis) occupying \> 30 % marrow space
* Patients who have received decitabine (DacogenTM) for MDS
* Patients who have received lenalidomide (RevlimidTM), steroids, erythropoietin, hydroxyurea, or growth factors within 4 weeks before study drug administration
* Patients who have received thalidomide within 8 weeks before study drug administration | 43,001 |
Study Objectives
RATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's ability to fight cancer.
PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma that can be removed during surgery.
Conditions: Brain and Central Nervous System Tumors
Intervention / Treatment:
BIOLOGICAL: recombinant adenovirus-p53 SCH-58500, PROCEDURE: conventional surgery
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma Progressive or recurrent disease following radiotherapy (54-64 Gy) and/or chemotherapy Tumor recurrence must have anatomic characteristics that allow safe and reasonable surgical intervention Measurable disease by serial MR or CT imaging No Li-Fraumeni syndrome or known germline defect in p53 gene No radiographically or surgically proven gliomatosis cerebri No tumors requiring immediate excision due to impending neurologic decline
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 25% Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2.5 times upper limit of normal (ULN) PT or PTT no greater than ULN Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No uncontrolled hypertension No uncontrolled or unstable angina pectoris No uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study HIV negative No other active malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled or serious concurrent infection or other serious medical illness that would preclude study therapy No viral syndrome diagnosed within 2 weeks prior to study No other underlying medical condition that would increase risk of study or obscure interpretation of adverse results No active adenoviral infection
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered No concurrent biologic therapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No prior interstitial chemotherapy such as Gliadel wafer implantation for present brain tumor No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy Radiotherapy: See Disease Characteristics No prior brachytherapy for present brain tumor At least 3 months since other prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics No prior radiosurgery for present brain tumor At least 3 weeks since other prior oncologic surgery No other concurrent oncologic surgery Other: No other concurrent investigational drugs | 8,433 |
Study Objectives
This is a randomized clinical trial that aims to investigate the effect of therapeutic listening anxiety and preoperative fear of patients hospitalized for surgical treatment of colorectal cancer. Physiological variables will be evaluated (heart rate, blood pressure and respiratory rate), cortisol and salivary amylase and anxiety scores by State-Trait Anxiety Inventory and fear for Surgery Fear Questionnaire. The data of the variables will be compared at two different times (before and after the intervention).
Conditions: Anxiety, Fear
Intervention / Treatment:
OTHER: Therapeutic listening
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* be 18 years of age;
* be hospitalized for performing surgical oncology;
* not be performing another treatment for cancer;
* not be participating in another study;
* be clinically well and / or stable (have score less than or equal to 3 by the Eastern Cooperative Oncology Group - Performance Status).
Exclusion Criteria:
* being illiterate, a condition that will prevent the participant to answer the questionnaires and instruments of the study, which are self-administered;
* be in possession of psychiatric disorders;
* be using medication containing corticosteroids. | 43,021 |
Study Objectives
The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels.
Conditions: Ovarian Cancer, Primary Peritoneal Carcinoma
Intervention / Treatment:
DRUG: Å6 subcutaneous injection
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Females ≥18 years of age
* Histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the Fallopian tube, or primary peritoneal carcinoma
* Completion of first-line chemotherapy
* Clinical remission as a result of chemotherapy
* History of normal CA125 level after initial course of therapy
* CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually \>= 28 days apart, provided that:
1. the 3rd sample is above the institution's ULN, and
2. the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's ULN
* No clinically evident disease progression, as assessed by history, physical examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI)
* ECOG Performance Status of 0 or 1
* No clinically significantly abnormal clinical laboratory tests or concomitant illnesses
* Ability and willingness to self-administer subcutaneous injections
* Although pregnancy is extremely unlikely in this patient population because of the disease and prior treatment, patients who have the potential to become pregnant must have a negative pregnancy test and must agree to practice an effective method of contraception throughout the trial.
Exclusion Criteria:
* Persistent adverse events due to agents administered more than 4 weeks earlier
* More than 1 course of previous chemotherapy for the qualifying cancer
* Disease requiring chemotherapy or radiotherapy
* Ascites
* Recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation | 43,323 |
Study Objectives
This is a Phase II trial non-randomized study to evaluate the objective response rate and stable disease rate (primary endpoints), progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous diagnostic procedures and baseline blood specimens for future correlative studies.
Conditions: Adenoid Cystic Carcinoma
Intervention / Treatment:
DRUG: doxorubicin and bortezomib
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 locally advanced, recurrent, or metastatic adenoid cystic carcinoma of the head and neck which is considered incurable by known therapies, as judged by the investigator.
* Patients should have cytologically or histologically confirmed adenoid cystic carcinoma of the head and neck.
* Patients must have unidimensionally measurable disease (RECIST criteria). If the only site of measurable disease is a previously irradiated area, the patient must have documented progression of disease in this area.
* All available prior computed tomography (CT) or magnetic resonance imaging (MRI) scans should be reviewed and noted, and measurements showing progression of disease should be documented whenever possible. However, documentation of disease progression is not mandatory for enrollment.
* Patients must have multigated acquisition scan (MUGA) scan showing left ventricular ejection function (LVEF) at or above the institutional lower limits of normal.
* Patients must have ECOG performance status 0-2.
* Patients should have recovered from prior surgery or radiation therapy. A minimum time period of 3 weeks should elapse between the completion of extensive radiation therapy for recurrent/metastatic disease and enrollment in the study.
* Patients must have normal organ and marrow function (as defined below) measured within one week prior to registration:
* Absolute neutrophil count \>1,500/mm3.
* Platelets greater than or equal to 100,000/mm3.
* Total bilirubin within normal institutional limits.
* Transaminases (AST and ALT) \<3 X ULN.
* Creatinine within normal institutional limits or creatinine clearance (CrCl) greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. CrCl will be calculated using the Cockcroft-Gault formula:
* Calculated Creatinine Clearance = (140-age) X actual body wt.(kg) 72 X serum creatinine. Multiply this number by 0.85 if the patient is female.
* Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. Patients must not have history of congestive heart failure of any grade according to Heart Association (NYHA) (see Appendix 2).
* Age \> 18 years and capacity to give informed consent.
* All patients must have given signed, informed consent prior to registration to the study.
Exclusion Criteria:
* No prior chemotherapy for recurrent / metastatic adenoid cystic carcinoma. Up to 1 prior biologic/targeted therapy regimen is allowed. Also, chemotherapy as part of initial potentially curative therapy (i.e. concurrent chemoradiotherapy) is allowed, if it was completed \>6 months earlier.
* Patients must not have any prior anthracyclines (doxorubicin, epirubicin, daunorubicin, idarubicin) or mitoxantrone, or bortezomib.
* No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
* Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, boron or mannitol.
* Patients must not have any pre-existing neuropathy of grade \> 1.
* Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Female patients who are pregnant or breast feeding or patients of reproductive potential not using an effective method of birth control will be excluded. Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of the first administration of chemo. Also, male patients whose sexual partners are women of child bearing potential not using effective birth control will be excluded.
* Patients with known positivity for human immunodeficiency virus (HIV) will be excluded due to possible pharmacokinetic interactions with bortezomib. Appropriate studies will be undertaken in HIV-positive patients who are receiving or not receiving combination anti-retroviral therapy when indicated.
* Patient must not have received other investigational drugs within 14 days before enrollment. | 8,792 |
Study Objectives
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
Conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Fulvestrant, DRUG: Exemestane
Location: Argentina, Belgium, Hungary, Germany, United States, South Africa, Israel, Canada, Spain, Brazil, France, United Kingdom, Denmark, Sweden, Russian Federation
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Biopsy confirmation of Breast Cancer
* Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
* Postmenopausal women defined as a women who has stopped having menstrual periods
* Evidence of hormone sensitivity
* Written informed consent to participate in the trial
Exclusion Criteria:
* Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
* Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
* Treatment with an investigational or non-approved drug within one month
* An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
* A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol) | 10,627 |
Study Objectives
This proof-of-principle clinical trial at Mayo Clinic studies how patients and their physicians understand and utilize predictive genetic risk assessment. A critical goal of this clinical trial is to understand how individual patients and their doctors perceive and respond to genetic risk information that is largely uncertain.
Conditions: Colon Cancer, Lung Cancer, Atrial Fibrillation, Diabetes Type 2, Obesity, Breast Cancer, Graves Disease, Osteoarthritis, Celiac Disease, Myocardial Infarction, Prostate Cancer
Intervention / Treatment:
GENETIC: SNP analysis
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* must be established EH patient or physician
Exclusion Criteria:
* pregnant women
* patient who have already purchased Navigenics Health Compass | 21,777 |
Study Objectives
Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies comparable to standard histology. Specifically, EM allows targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, which will improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as well as flat mucosa.
EM will provide accurate place and size of IEN which will impact the physician's decision to biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the number of unnecessary biopsies and as well as enable the physician to perform EMR at the time of the initial examination, rather than delaying endoscopic treatment after the pathology is available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.
Conditions: Barrett's Esophagus, Esophageal Intraepithelial Neoplasia
Intervention / Treatment:
PROCEDURE: endomicroscopy
Location: Germany, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Surveillance of Barrett's esophagus or suspected or known BE associated neoplasia
Exclusion Criteria:
* Allergy or prior reaction to the fluorescent contrast agent fluorescein sodium
* Unable to give informed consent.
* Pregnant or breastfeeding women
* Known advanced adenocarcinoma in the esophagus
* Dysplastic or suspected malignant esophageal lesion 0 BE lesions 2 cm or more in size with Paris classification of 0-Ip (polypoid), 0-Is (protruding sessile), 0-IIa (flat elevated), or 0-IIb (flat)
* Lesions of any size with Paris 0-IIc (superficial shallow depressed) or 0-III (excavated)
* Acute gastrointestinal bleeding
* Coagulopathy defined by Partial Thromboplastin Time (PTT) \> 50 sec, or International Normalized Ratio (INR) \> 2.0, platelets \< 40,000, or on chronic anticoagulation
* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy.
* History of a severe allergic reaction (anaphylaxis)
* Known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope | 14,502 |
Study Objectives
The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.
Conditions: Advanced Solid Tumor
Intervention / Treatment:
DRUG: LY3039478
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic.
* In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate.
* Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Adequate organ function, including hematologic, hepatic, and renal.
* Estimated life expectancy of ≥12 weeks.
Exclusion Criteria:
* Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively.
* Have serious preexisting medical conditions.
* Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea.
* Have an active bacterial, fungal, and/or known viral infection.
* Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results. | 30,740 |
Study Objectives
Women with metastatic breast cancer, receiving first line treatment of any kind (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this trial. In connection to treatment, blood samples for determination and enumeration of circulating tumour cells will be collected at different time points. Serum and plasma will be collected and stored for future analysis of RNA and DNA.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
Location: Sweden
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Women with metastatic breast cancer
* ECOG performance status 0-2
* Age over18 years
* Signed informed concent
* Predicted life expectancy over 2 months
* Planned for first line systemic treatment for metastatic disease (chemotherapy, antibody treatment or endocrine treatment)
* Standard imaging evaluation within 4 weeks of inclusion
* Planned for standard imaging within 16 weeks after start of therapy
Exclusion Criteria:
* Prior medical therapy for metastatic disease (prior adjuvant chemotherapy, radiotherapy or endocrine therapy is permitted)
* Inability to understand information about the study
* Other malignant disease with the exception of curatively treated basal cell or squamous cell cancer of the skin and cancer in situ of the cervix | 41,606 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.
Conditions: Esophageal Cancer
Intervention / Treatment:
DRUG: Docetaxel, DRUG: Floxuridine, DRUG: Leucovorin, DRUG: Oxaliplatin, GENETIC: Microarray analysis, GENETIC: reverse transcriptase-polymerase chain reaction, PROCEDURE: 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 | DISEASE CHARACTERISTICS:
* Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:
* Stage II or III disease
* Resectable disease
* Previously untreated disease
* No stage I (mucosal only) or stage IV (metastatic) disease
PATIENT CHARACTERISTICS:
* WBC \> 3,000/mm\^3
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Creatinine ≤ 2.0 mg/dL
* Bilirubin \< 2 times normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must have central venous access
* No other malignancy within the past 5 years
* No concurrent medical or psychiatric problem that would preclude study treatment
* No contraindications to paclitaxel
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy to the esophagus
* No oral cryotherapy (e.g., ice chips) on day 1 of each course | 3,890 |
Study Objectives
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
DRUG: paclitaxel, DRUG: FOLFIRI, DRUG: ABT-165, DRUG: ABBV-181
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
* Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
* Subject has adequate bone marrow, renal, hepatic and coagulation function.
* Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).
* Women of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline prior to the first dose of study drug. Female subject considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year. Women of childbearing potential and men must agree to use adequate contraception.
* Subjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects in the combination therapy cohorts who are to receive ABBV-181, an anti-PD1 antibody, must also meet other criteria described in the Protocol.
Exclusion Criteria:
* Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.
* Subject has uncontrolled metastases to the central nervous system (CNS).
* Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
* Subject has history (within previous 5 years) of clinically significant pulmonary hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic heart failure, cardiomyopathy, myocardial infarction, unstable/severe angina pectoris, cardiac arrhythmia requiring medication, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, cerebrovascular accident, transient ischemic attack or the left ventricular ejection fraction (LVEF) less than 50%.
* Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects receiving ABBV-181 must not meet other exclusion criteria described in the Protocol. | 3,556 |
Study Objectives
The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg in combination with Temozolomide in subjects with unresectable advanced neuroendocrine tumours of the lung or thymus as Disease Control Rate at 9 months.
Conditions: Neuroendocrine Tumours
Intervention / Treatment:
DRUG: Lanreotide (Autogel formulation) and Temozolomide
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological documented unresectable advanced (locally or metastatic) well or moderately differentiated neuroendocrine tumors of the lung or thymus (typical and atypical carcinoids according to the World Health Organisation (WHO) 2004 criteria);
* Imaging documented progression within 12 months before screening visit (V1), according to RECIST criteria v 1.1;
* Measurable disease, as defined by RECIST criteria v 1.1, on a CT scan performed at screening visit (V1);
* Octreoscan or Ga68-DOTA-TATE/TOC/NOC-PET-TC within 12 months before screening visit (V1);
* Adequate liver, renal and bone marrow function.
Exclusion Criteria:
* Poorly differentiated neuroendocrine carcinoma and mixed Neuroendocrine tumours (NET), according to WHO 2004 criteria
* Neuroendocrine tumours other than lung or thymus
* Non-neuroendocrine thymic neoplasm
* Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
* Treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit (V1)
* Treated with a number of systemic therapy lines \> 3 prior to screening visit (V1), and any of the following:
1. for chemotherapy no more than 1 line prior to V1
2. for somatostatin analogue no more than 1 line therapy, considered as treatment lasting more than 6 months, prior to V1 no therapy with Temozolomide (TMZ) prior to V1
3. Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
* Received external palliative radiotherapy within the last 28 days prior to screening visit (V1)
* Received locoregional therapies (Transarterial embolization, Transcatheter arterial chemoembolization, thermo-ablation with radio-frequency) and Selective internal radiotherapy within 3 months prior to screening visit (V1)
* Presence of symptomatic brain metastasis
* Subjects with symptomatic cholelithiasis at screening visit (V1) | 11,394 |
Study Objectives
RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.
Conditions: Non-melanomatous Skin Cancer
Intervention / Treatment:
DRUG: imiquimod, PROCEDURE: conventional surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model:
Masking: DOUBLE | DISEASE CHARACTERISTICS:
* Histologically confirmed basal cell skin cancer
* Superficial or nodular disease
* No aggressive disease
* At least 1 lesion at least 7 mm in diameter that meets the following criteria:
* Primary tumor (no recurrent or previously treated disease)
* Located on the scalp, face (including ears), trunk, or proximal extremities
* Qualifies for surgical excision as primary therapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No evidence of a clinically significant or unstable medical condition that would adversely affect blood circulation
Other
* No dermatological disease (e.g., psoriasis or eczema) at the treatment site that may be exacerbated by treatment with imiquimod or interfere with examination
* No febrile viral infection within the past 4 weeks
* No evidence of a clinically significant or unstable medical condition that would adversely affect immune function
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior interferon, interferon inducers, or immunomodulators
* No concurrent interferon, interferon inducers, or immunomodulators
Chemotherapy
* More than 6 months since prior anticancer chemotherapy
* No concurrent anticancer chemotherapy
Endocrine therapy
* More than 4 weeks since prior oral or inhaled (more than 600 mcg/day for fluticasone or equivalent) corticosteroids
* More than 4 weeks since prior topical steroids to the target tumor
* Concurrent topical steroids in non-target areas are allowed provided amount used is ≤ 2 g of fluorinated steroids daily for \> 1 week or 6 g of beclomethasone for \> 1 week
* No concurrent oral or inhaled corticosteroids
Radiotherapy
* Not specified
Surgery
* More than 4 months since prior biopsy
Other
* More than 4 weeks since prior immunosuppressive therapies
* More than 4 weeks since prior cytotoxic or investigational drugs
* No concurrent immunosuppressive therapies
* No other concurrent cytotoxic or investigational drugs | 31,551 |
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 3-AP in treating patients who have advanced cancer.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: triapine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic malignancy Failed one or more prior standard therapies or considered unlikely to respond to any currently available therapy Measurable or evaluable disease No active, untreated CNS metastases (stable for at least 2 months and no evidence of new CNS metastases)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) No bleeding disorder (except occult blood for gastrointestinal cancers) Hepatic: Bilirubin no greater than 2.0 mg/dL ALT, AST, and alkaline phosphatase no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN with liver metastases) PT and PTT no greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active heart disease No myocardial infarction within the past 3 months No symptomatic coronary artery disease or heart block No uncontrolled congestive heart failure Pulmonary: No moderate to severe compromise of pulmonary function Other: No active infection No mental deficits and/or psychiatric history that would preclude study No other concurrent life threatening illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 18 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No persistent chronic toxicity from prior chemotherapy greater than grade 1 Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Concurrent radiotherapy to single site of progressive disease allowed during first course of study treatment Surgery: Not specified Other: At least 3 weeks since any prior treatment for malignancy and recovered No other concurrent investigational drug | 1,267 |
Study Objectives
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Nivolumab 360mg, DRUG: Paclitaxel 80mg/m^2, DRUG: Doxorubicin 60mg/m^2, DRUG: Cyclophosphamide 600mg/m^2, DRUG: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2, DRUG: Trastuzumab 8mg/kg and 6 mg/kg, DRUG: Pertuzumab 840mg and 420mg
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:
* Newly diagnosed inflammatory breast cancer without distant metastases and have not received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed: Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and HER2-positive
Exclusion Criteria:
* Clinical or radiologic evidence of distant metastases
* Malignancy that progressed within the last five years.
* Cardiac disease (history of and/or active disease)
* HIV positive
* Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0
* Allogeneic stem cell or solid organ transplantation
* Autoimmune disease where in the opinion of the Investigator would preclude the use of immunotherapy
* Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonitis
* Tuberculosis
* Pregnancy or lactation
* Treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunosuppressive medications
* Cardiopulmonary dysfunction
* Clinically significant history of liver disease, including cirrhosis, autoimmune hepatic disorders, HIV infection, or active Hepatitis B or Hepatitis C
* Subject is pregnant or nursing
* Known hypersensitivity to the components of the study drugs(s) | 1,899 |
Study Objectives
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
Conditions: Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment
Intervention / Treatment:
DRUG: 145 mg/m2 NKTR 102, DRUG: 120 mg/m2 NKTR 102, DRUG: 50 mg/m2 NKTR 102
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Relapsed or progressive advanced solid tumor malignancies
* Measurable or non-measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy greater than 3 months
* Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments
* Adequate bone morrow and kidney function
* No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis
* Agree to use adequate contraception
Exclusion Criteria:
* Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
* Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
* Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1
* UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1\*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1\*37)
* Major surgery within 4 weeks prior to day 1
* Undergone a liver or other organ transplant
* Concurrent treatment with other anti-cancer therapy
* Untreated central nervous system metastases
* Ongoing or active infection
* Chronic or acute GI disorders resulting in diarrhea
* Pregnancy or lactation | 35,773 |
Study Objectives
This research will examine the feasibility of conducting a strict whole-food, plant-based dietary intervention in women with stable metastatic breast cancer currently undergoing conventional treatments. In addition, this research will provide preliminary data on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood biomarkers linked to cancer progression, and numerous symptom questionnaires.
Conditions: Metastatic Breast Cancer, Breast Cancer Stage IV
Intervention / Treatment:
BEHAVIORAL: Plant-Based Diet
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Women with a confirmed diagnosis of metastatic breast cancer with a stable treatment regimen, demonstrated by no changes in primary cancer therapy 6 weeks prior to consent and no anticipated changes in primary cancer therapy in the 4 weeks following consent.
* Systemic therapy may consist of any conventional treatment including anti-hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have previously declined conventional cancer therapy are also eligible provided they meet all other eligibility criteria.
* Expected to survive for at least 6 months.
* Eligibility classification for enrollment into the study - T: any; N: any; M:1.
* Any ER/PR/HER2 status is eligible.
* Age \> 18 years.
* Must be willing to adopt a strict, whole-foods, plant-based diet.
* Participant must be willing and able to comply with the protocol for the duration of the study including scheduled testing and weekly office visits.
* Able to speak and read English fluently.
Exclusion Criteria:
* Inability to tolerate a normal diet.
* Current use of insulin or sulfonylureas.
* Active malabsorption syndrome at time of consent (ie. Crohn's disease, major bowel resection leading to permanent malabsorption).
* Current eating disorder.
* Uncontrolled diarrhea.
* Plant-based food allergies or intolerances.
* Recent consumption (in the past 6 months) of a vegan diet.
* GFR \< 30 on 2 or more lab tests in the past 90 days.
* Serum potassium \> 5.3 on 2 or more lab tests in the past 90 days.
* Major surgery within 2 months of starting study program.
* Psychiatric disorder that prohibits giving informed consent.
* Current smoking.
* Current high risk alcohol use (\> 7 drinks per week).
* Current illicit substance use.
* Current warfarin use. | 19,118 |
Study Objectives
This is a global randomized, placebo-controlled, double-blinded Phase 2 study designed to compare treatment of ARQ 197 versus placebo in patients with unresectable HCC who had radiographic disease progression after systemic first line therapy or were unable to tolerate the therapy.
Conditions: Unresectable Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: ARQ 197, DRUG: Placebo
Location: Belgium, Germany, United States, Canada, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Written informed consent granted prior to initiation of any study-specific screening procedures
* 18 year of age or older
* Histologically or cytologically confirmed HCC
* Archival, fresh core needle biopsy or fine needle aspiration (FNA) tumor samples
* Received at least one cycle of prior systemic therapy (at least 3 weeks for continuously administered drugs) and experienced radiographic disease progression or was unable to tolerate therapy. If intolerance was manifested by a Grade 3 or 4 event of such nature that re-challenge is not acceptable, less than 3 weeks of continuous administration will be allowed
* Discontinued prior treatment for at least 4 weeks, or at least 2 weeks (14 days) if drug was administered continuously and orally (e.g. sorafenib or sunitinib), prior to the study randomization
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1
* Local or loco-regional therapy (i.e., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ≥4 weeks prior to randomization
* Measurable disease as defined by a modified version of the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (see section 9). Tumor lesions previously treated with local therapy should demonstrate clear dimensional increase by radiographic assessment in order to be selected as target lesion(s) at baseline. (Radiological assessment needs to be redone within 7 days prior to randomization if the pre-study AFP level has increased by more than 30% since the last AFP level taken one to four months prior to randomization)
* Adequate bone marrow, liver, and renal functions at Pre-Study Visit, defined as:
* Platelet count ≥ 60 × 10\^9/L
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L
* Total bilirubin ≤ 2 mg/dL
* Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5 × upper limit of normal (ULN)
* Serum creatinine ≤1.5 × ULN
* International normalized ratio (INR) 0.8 to 1.4 or ≤3 for patients receiving anticoagulant such as coumadin or heparin. Patients who are therapeutically anticoagulated are allowed to participate provided that no prior evidence of underlying abnormality exists in these parameters
* Albumin ≥ 2.8 g/dL
* Women of childbearing potential must have a negative pregnancy test performed within ten days prior to the start of study drug
* Male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
Exclusion Criteria:
* More than 1 prior systemic regimen
* Child-Pugh B-C cirrhotic status
* Previous or concurrent cancer that is distinct from HCC in primary site or histology, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \>3 years prior to enrollment is permitted
* History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification within 6 months prior to study entry; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as ≥Grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring \>6 months prior to study entry is permitted)
* Active clinically serious infections defined as ≥ Grade 3 according to NCI CTCAE, version 4.0.
* Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance
* Known human immunodeficiency virus (HIV) infection
* Pregnancy or breast-feeding
* History of liver transplant
* Inability to swallow oral medications
* Clinically significant gastrointestinal bleeding occurring ≤4 weeks prior to randomization | 189 |
Study Objectives
In recent years, the development of lung cancer has been improved from pathological level to the molecular level. Research showed that there are many gene mutations in non-small cell lung cancer (NSCLC), and some activating mutations have become the hotspots in target therapy area. With the development of targeted drug research, the molecular classification of NSCLC will be more and more important. But a large number of clinical data showed that gene mutation in Chinese NSCLC patients is significantly different from Caucasian population, which suggesting that it is necessary to identify gene mutation profile in Chinese patients with NSCLC.
Six hundred NSCLC paraffin tissue samples was collected during operation from Tianjin Cancer hospital in 2009-2012, which including lung squamous cell carcinoma and adenocarcinoma. The target area of 295 genes, including lung cancer drive genes, important signal pathway genes, drug resistance genes will be detected by next-generation sequencing deep (average 1000X). We will identify gene mutation profile for Chinese lung squamous cell carcinoma and adenocarcinoma patients. The aim is to find related predictor and prognostic factors by analysing the relationship between these gene mutations and clinical characteristics and follow-up treatment.
Conditions: NSCLC
Intervention / Treatment:
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients enrolled from 2009 to 2012. Histological confirmed NSCLC.
Exclusion Criteria:
* Received any systemic or local treatment before surgery. Along with other malignant tumors. Lack up intact follow-up information. | 2,747 |
Study Objectives
This phase I trial studies the side effects and best dose of sapanisertib and ziv-aflibercept in treating patients with solid tumors that have come back (recurrent) and have spread to another place in the body (metastatic) or cannot be removed by surgery (unresectable). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ziv-aflibercept may stop the growth of solid tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving sapanisertib with ziv-aflibercept may kill more tumor cells.
Conditions: Advanced Malignant Solid Neoplasm, Fibrolamellar Carcinoma, Metastatic Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Neuroendocrine Tumor, Recurrent Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Solid Neoplasm
Intervention / Treatment:
DRUG: Sapanisertib, BIOLOGICAL: Ziv-Aflibercept
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:
* Patients with advanced or metastatic cancer that is refractory to standard therapy or relapsed after standard therapy; patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* Patients enrolled in the expansion cohort must have biopsiable disease; there will be preferential enrollment of patients with pancreatic neuroendocrine tumors or ovarian cancer during the dose expansion cohort
* Patients must be \>= 4 weeks beyond treatment of any chemotherapy, other investigational therapy, hormonal, biological, targeted agents or radiotherapy, and must have recovered to =\< grade 1 toxicity or previous baseline for each toxicity; exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Life expectancy of greater than 3 months
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 9 g/dL
* Total bilirubin =\< 1.5 x institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
* Creatinine =\< 1.5 x institutional upper limit of normal OR creatinine clearance \>= 60 mL/min for patients with creatinine levels above institutional normal
* Fasting serum glucose =\< 130 mg/dL
* Fasting triglycerides =\< 300 mg/dL
* Glycosylated hemoglobin (HbA1c) \< 7.0%
* Patients must have evaluable or measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Women of child-bearing potential MUST have a negative serum or urine pregnancy test within 7 days unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; women of child-bearing potential must agree to use 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling \[e.g.; United Surgical Partners International (USPI), Summary of Product Characteristics (SmPC), etc;\]) after the last dose of study drug; or agree to practice true abstinence; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or
* Agree to completely abstain from heterosexual intercourse
* Ability to understand and the willingness to sign a written informed consent document
* Ability to swallow oral medications
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to =\< grade 1 adverse events due to agents administered more than 4 weeks earlier
* Patients who are receiving any other investigational agents
* 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
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228) or ziv-aflibercept
* Uncontrolled intercurrent illness including active infection
* Pregnant women are excluded from this study because MLN0128 (TAK-228) and ziv-aflibercept are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MLN0128 (TAK-228) and ziv-aflibercept, breastfeeding should be discontinued if the mother is treated with MLN0128 (TAK-228) and ziv-aflibercept; these potential risks may also apply to other agents used in this study
* Patients with known human immunodeficiency virus infection are not to be enrolled in the study
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days or manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease that may alter the absorption of MLN0128 (TAK-228)
* New York Heart Association class III or greater congestive heart failure within last 6 months or uncontrolled hyperlipidemia (cholesterol \> 300 mg/dl; triglyceride 2.5 X upper limit of normal \[ULN\] despite lipid lowering agent) within last 3 months
* Uncontrolled diabetes (fasting serum glucose \> 130 mg/dl) despite best medical management or poorly controlled diabetes mellitus defined as hemoglobin (Hb)A1c \> 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met
* History of uncontrolled hypertension, defined as blood pressure \> 150/95 mmHg, or systolic blood pressure \> 180 mmHg when diastolic blood pressure \< 90 mmHg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment
* Urine protein should be screened by dipstick or urine analysis; for proteinuria \> 1+ or urine protein: creatinine ratio \> 1.0, 24-hour urine protein should be obtained and the level should be \< 2000 mg for patient enrollment
* Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of- therapeutic range international normalized ratio (INR) (\> 3) within the 4 weeks prior to drug administration
* Evidence of clinically significant bleeding diathesis or underlying coagulopathy, non-healing wound
* History of any of the following within the last 6 months prior to study entry:
* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures
* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)
* Placement of a pacemaker for control of rhythm
* Pulmonary embolism
* Significant active cardiovascular or pulmonary disease at the time of study entry, including:
* Uncontrolled high blood pressure (i.e., systolic blood pressure \> 150 mm Hg, diastolic blood pressure \> 95 mm Hg)
* Pulmonary hypertension
* Uncontrolled asthma or oxygen (O2) saturation \< 90% by pulse oximetry on room air
* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement
* Medically significant (symptomatic) bradycardia
* History of arrhythmia requiring an implantable cardiac defibrillator
* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g. repeated demonstration of QTc interval \> 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
* Psychiatric illness/social situations that would limit compliance with study requirements
* Have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
* Patients who are taking proton pump inhibitor (PPI) within 7 days before receiving the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug
* Patients with known history of hepatitis B surface antigen-positive, or known history or suspected active hepatitis C infection are not to be enrolled in the study | 18,431 |
Study Objectives
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed \< one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.
Conditions: Acute Myelogenous Leukemia
Intervention / Treatment:
DRUG: clofarabine (IV formulation)
Location: 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:
* note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
* Diagnosis of AML according to FAB classification
* Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory
* A Karnofsky Performance Status (KPS) of greater than or equal to 60.
* If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
* Signed, written informed consent.
* Ability to comply with study procedures and follow-up examinations.
* Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration.
* Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study.
Exclusion Criteria:
* note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
* Received previous treatment with CLOFARABINE.
* Received more than two previous induction regimens or cycles for the treatment of AML.
* Relapsed \> 1 year.
* Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
* Are pregnant or lactating.
* Have psychiatric disorders that would interfere with consent, study participation or follow-up.
* Are receiving any other chemotherapy or corticosteroids. Patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
* Have any other severe concurrent disease.
* Have symptomatic CNS involvement.
* Have chronic myelogenous leukemia (CML) in lymphoid blast crisis). | 18,942 |
Study Objectives
This study evaluates the use of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed/refractory solid tumors or leukemia. The medications cyclophosphamide and etoposide are standard drugs often used together for the treatment of cancer in children with solid tumors or leukemia.
Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults with multiple myeloma (a type of cancer). However, this drug is not approved to treat children with relapsed/refractory solid tumors or leukemia. With this research, we plan to determine the DLTs and MTD of Carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors.
Conditions: Relapsed Solid Tumors, Refractory Solid Tumors, Relapsed Leukemia, Refractory Leukemia
Intervention / Treatment:
DRUG: Carfilzomib, DRUG: Cyclophosphamide, DRUG: Etoposide
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Patients must have either of the following:
1. Relapsed/refractory leukemia in 2nd or greater relapse or who have failed at least one re-induction attempt after relapse or for refractory disease. Patients must meet the WHO classification with ≥ 5% blasts in the bone marrow or must have definitive extramedullary disease (e.g. chloromas, skin lesions). Patients may have asymptomatic CNS 1 or CNS 2 disease, but not CNS 3 or symptomatic CNS disease.
OR
2. Relapsed/refractory non-CNS solid tumor that has not responded or has relapsed and for which no standard treatment is available. Patients may not have primary CNS tumors or CNS metastases. Lymphoma patients are permitted. Patients do not need to have measurable disease.
2. Age 6 months - 29.99 years at enrollment
3. Life expectancy ≥ 3 months
4. Lansky or Karnofsky ≥50
5. Prior therapy
1. Patient must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, radiotherapy, or surgery prior to study entry.
2. Myelosuppressive therapy- At least 14 days must have elapsed since the administration of previous therapy. Six weeks must have elapsed from the administration of nitrosureas or mitomycin C. For patients with ALL on maintenance therapy, they may be eligible if 7 days have elapsed and they are recovered from the toxic effects of the chemotherapy. This restriction does not include intrathecal chemotherapy, which is permitted.
3. Biologic agents- At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody. Seven days must have elapsed since the last dose of retinoids
4. Radiation therapy - At least 14 days must have elapsed for local XRT. At least 90 days must have elapsed if prior radiation to ≥50% of the pelvis, the spine, or other substantial bone marrow radiation including TBI.
5. Hematopoietic growth factors- At least 7 days must have elapsed since the last dose of G-CSF or GM-CSF. At least 14 days must have elapsed since last dose of pegfilgrastim (Neulasta®).
6. Patient must be ≥ 3 months from hematopoietic stem cell transplant, must not have active GVHD, and must be off all immunosuppression
7. Organ function:
1. Either a serum creatinine ≤ ULN for age, or calculated or measured GFR ≥ 70 mL/min/1.73 m2
2. Total bilirubin ≤ 1.5 x ULN for age, direct bilirubin ≤ ULN for age
3. AST and ALT ≤ 3 x ULN for age unless elevation can be clearly attributed to liver leukemia or metastases
4. ECHO shortening fraction ≥ 27%
5. Pulse Oximetry measurement ≥ 95% saturation without supplemental oxygen
8. Bone marrow function:
1. Hgb ≥10 g/dL - can be transfused
2. Plts ≥ 75,000 - cannot be transfused (must be ≥ 7 days from last plt transfusion)
3. ANC ≥ 750 - cannot be transfused (must be ≥ 72 hours from last neutrophil infusion)
However, the plt and ANC requirements can be waived if low counts thought to be secondary to leukemia or tumor bone marrow infiltration
9. Reproductive function:
1. Female patients of childbearing potential must have a negative serum pregnancy test confirmed within 7 days prior to enrollment
2. Female patients with infants must agree not to breastfeed their infants while on the study
3. Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 3 months after study treatment
10. Written informed consent
Exclusion Criteria:
1. Prior treatment with carfilzomib
2. Known allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).
3. Down syndrome
4. Fanconi Anemia or other underlying bone marrow failure syndrome
5. Pregnant or lactating females
6. Known history of Hepatitis B or C or HIV
7. Patient with any significant concurrent illness
8. Patient with uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs/symptoms despite appropriate treatment
9. Patient with illness, psychiatric disorder or social issue that could compromise patient safety or compliance with the protocol treatment or procedures, or interfere with the consent, study participation, follow-up, or interpretation of study results. | 25,658 |
Study Objectives
The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 4 other provinces: British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.
Conditions: Hypertension, Depression, Anxiety, Musculoskeletal Pain, Arthritis, Rheumatoid Arthritis, Osteoporosis, Chronic Obstructive Pulmonary Disease (COPD), Asthma, Chronic Bronchitis, Cardiovascular Disease, Heart Failure, Stroke, Transient Ischemic Attacks, Ulcer, Gastroesophageal Reflux, Irritable Bowel, Crohn's Disease, Ulcerative Colitis, Diverticulosis, Chronic Hepatitis, Diabetes, Thyroid Disorder, Cancer, Kidney Disease, Urinary Tract Problem, Dementia, Alzheimer's Disease, Hyperlipidemia, HIV, Multimorbidity
Intervention / Treatment:
BEHAVIORAL: TIP / IMPACT Plus Care Coordination
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | For Quantitative (Study 2.2):
Inclusion Criteria for Patients:
* 3+ Chronic Conditions
* 18 to 80 years of age
* Eligible for TIP/IMPACT Plus program
* Must live in catchment area for TIP/IMPACT Plus program (Toronto, Ontario, Canada)
Exclusion Criteria for Patients:
* Unable to reasonably respond to questionnaires or provide informed consent (ie. cognitive impairment or language barrier)
* Deemed by provider to be too fragile
For Qualitative (Study 2.1):
Inclusion Criteria:
* Decision Makers: Responsible for policy and financial decisions related to the TIP / IMPACT Plus program
* TIP / IMPACT Providers: Providers that have delivered the TIP / IMPACT Plus intervention to at least one patient, including pharmacist, nurse, nurse practitioner, physiotherapist, social worker, dietitian, occupational therapist, personal care worker / home care coordinator
* Family Physicians / Specialists: Those that take part in the TIP / IMPACT Plus intervention, including internist, psychiatrist, and family physician
* Patients: Need to meet the inclusion criteria of the TIP / IMPACT Plus program, 18 to 80 years of age, 3+ chronic conditions, and have received the intervention a minimum of 4 months prior to the qualitative interview
* Family and Caregivers: Need to be a family member or caregiver of a TIP / IMPACT Plus patient that has received the intervention a minimum of 4 months prior to the qualitative interview.
* Referral Provider: Emergency Department doctor, nurse practitioner, CCAC coordinator or representative community family doctor that has referred patients to the TIP / IMPACT Plus program.
Exclusion criteria:
* Decision Makers that are not knowledgeable about or involved with the TIP / IMPACT Plus program
* Providers/Family Physicians/Specialists that have not ever referred to or taken part in a TIP / IMPACT Plus intervention or have not been active with the program in the last year
* Family and Caregivers of Patients or Patients themselves that haven't yet received the TIP / IMPACT Plus intervention or those that received the intervention within the last 4 months | 41,434 |
Study Objectives
RATIONALE: A home-based exercise and/or diet program may improve the quality of life of breast cancer patients by preventing an increase in body fat and weight and a loss of lean body tissue.
PURPOSE: This randomized phase II trial is studying the effectiveness of three home-based diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.
Conditions: Breast Cancer, Depression, Weight Changes
Intervention / Treatment:
DIETARY_SUPPLEMENT: Calcium-Rich Diet, OTHER: Arm 2: Exercise + Calcium-Rich Diet, OTHER: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage I, II, or IIIA
* Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal Status
* Premenopausal, defined as at least 1 of the following:
* Less than 4 months since last menstrual period at diagnosis
* Follicle-stimulating hormone level in the premenopausal range
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* No calcium-based kidney stones
Cardiovascular
* No angina within the past 6 months
* No myocardial infarction within the past 6 months
* No abnormal MUGA and/or stress test
Other
* Not pregnant or nursing
* Access to a telephone
* Able to read and speak English
* No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* No history of hyperthyroidism or hypothyroidism
* No paralysis
* No osteoarthritis with uncontrolled joint pain that would preclude exercise
* No diverticulitis
* No serious medical or psychiatric illness that would preclude giving informed consent or completing study therapy or quality of life questionnaires
* No medical condition that would interfere with body composition assessment
* No medical condition for which unsupervised exercise is contraindicated
* No medical condition for which a high vegetable and fruit diet or a calcium-rich diet is contraindicated
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* No prior bilateral oophorectomy
* No prior amputation
* No concurrent transverse rectus abdominis myocutaneous surgery
* No concurrent surgery
Other
* No concurrent blood-thinners (e.g., coumadin or warfarin) | 27,480 |
Study Objectives
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
Conditions: Prostate Cancer
Intervention / Treatment:
RADIATION: High Dose brachytherapy boost, RADIATION: External beam radiotherapy
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. Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0.
2. Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
3. The patient will be clinically M0.
4. Zubrod status 0-1.
5. No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable.
6. One of the following combinations of factors:
Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) \>10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20
7. Patients must sign a study-specific consent form prior to registration.
Exclusion Criteria:
1. Stage T4 disease.
2. Lymph node involvement (N1).
3. Evidence of distant metastases (M1).
4. Radical surgery for carcinoma of the prostate.
5. Previous hormonal therapy beginning \> 120 days prior to registration.
6. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
7. Prior transurethral resection of the prostate (TURP).
8. Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
9. Hip prosthesis. | 6,396 |
Study Objectives
This study aims to examine whether the pain of topical photodynamic therapy (PDT) is significantly different when using low irradiance ambulatory light emitting diode (LED) devices compared with conventional higher irradiance hospital based LED light sources when used for superficial non-melanoma skin cancer. The investigators are also investigating the phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.
Conditions: Non-melanoma Skin Cancer
Intervention / Treatment:
DEVICE: Ambulight (Ambicare Health)
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Bowen's disease or superficial basal cell carcinoma referred for PDT and lesion not greater than 2.4cm diameter
Exclusion Criteria:
* Unable to give consent, \>2cm diameter, lesions on highly curved surfaces where ambulatory device would not adhere | 28,693 |
Study Objectives
Flap reconstruction is utilised increasingly for repair of skin and soft tissue defects following pelvic exenteration. Many methods have been proposed but the outcomes associated with each remain largely unknown and the choice dependant on surgeon preference and patient/ disease characteristics. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.
Conditions: Pelvic Cancer, Rectal Cancer, Flap Disorder, Flap Ischemia, Flap Necrosis, Perioperative Complication
Intervention / Treatment:
PROCEDURE: Flap reconstruction
Location: Ireland
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynaecological, Sarcoma)
* Aged over 18 years
* Undergoing a multi-visceral extended pelvic resection and requiring reconstruction of a skin and soft tissue defect as a result
* Time period: 1st July 2016 - 1st July 2021
Exclusion Criteria:
* Strong evidence of metastatic or peritoneal disease
* No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration, or flap reconstruction performed as a delayed procedure or as a response to a complication of prior pelvic exenteration
* Insufficient patient follow-up (Minimum of 30 days) | 19,769 |
Study Objectives
The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Cohort A
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE | Inclusion Criteria:
- Cohort A
1. Documentation of ER-positive and/or PR-positive tumor (\>=1% positive stained cells) .
2. Patients must satisfy the following criteria for prior therapy:
- Progressed during treatment or within 12 months of completion of adjuvant hormone therapy.
or Progressed while prior hormone therapy for advanced/metastatic breast cancer. Two previous line of hormone therapy for advanced/metastatic disease is allowed.
3. Patients who have hormone therapy that can be expected for advanced /metastatic disease.
Cohort B
4. Patients who have come to be non-responsive more than two line of chemotherapy
5. Prior chemotherapy with anthracycline and taxane agent
Cohort A and B
6. Female patients who are histologically or cytologically confirmed to have breast cancer
7. Patients who have distant metastatic lesion as follow
- More than one bone lesion for radiation therapy
8. Patients with cancer confirmed to be HER2-negative.（
9. Patients with a measurable lesion based on RECIST 1.1.
10. Patients aged \>= 20 years at informed consent
11. Patients with ECOG PS of 0 to 1.
12. Patients without any severe disorder in the major organs.
13. Patients expected to survive for ≥ 90 days.
14. Patients of childbearing potential must be using an acceptable method of contraception to avoid pregnancy and must not be breastfeeding for 18 weeks after the last dose of investigational product
15. Patients who have provided written informed consent themselves.
Exclusion Criteria:
-
Exclusion Criteria:
1. Patients who have neuropathy (more than Grade 2)
2. Patients with any active autoimmune disease or a history of known autoimmune disease.
3. Patients who has a history of pneumonitis or interstitial lung disease.
4. Active, untreated central nervous system metastasis.
5. Patients with pericardial effusion, pleural effusion or ascites requiring treatment
6. Patients with uncontrolled diabetes mellitus
7. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment.
8. Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment.
9. Pregnant or breast-feeding women.
10. Prior therapy with Nivolumab, anti CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
11. Patients considered ineligible for participation in this study by their attending physicians | 17,568 |
Study Objectives
If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.
Conditions: Prostatic Intraepithelial Neoplasia
Intervention / Treatment:
DRUG: GTX-006 (Acapodene)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | * Must have confirmed high grade PIN on prostate biopsy within past 6 months.
* Must have a serum PSA \<12 ng/ml.
* Can not have prostate cancer.
* Have significant ocular opacities.
* Can not take finasteride or other testosterone like supplement. | 39,188 |
Study Objectives
Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. However, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA intravenously or switch to Sustained-Release Morphine orally after successful titraton with hydromorphone PCA intravenously in severe cancer pain.
Conditions: Cancer Pain
Intervention / Treatment:
DRUG: PCA IV Hydromorphone (continuous dose = 0), DRUG: PCA IV Hydromorphone (continuous dose ≠ 0), DRUG: Oral morphine
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. The patients were 18-80 years old and diagnosed as malignant tumor by pathology;
2. Patients with cancer pain is NRS pain score ≥ 7 during previous 24 hours;
3. Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study ;
4. Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization ;
5. Patients or his/her caregivers who are able to fill out the questionnaire forms ;
6. Ability to correctly understand and cooperate with medication guidance of doctors and nurses ;
7. Without psychiatric problems;
8. ECOG performance status ≤3;
9. Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）;
10. The subjects voluntarily signed the informed consent.
Exclusion Criteria:
1. The pain is confirmed not due to cancer;
2. Patients with severe post-operative pain;
3. Patients with paralytic ileus;
4. Patients with brain metastasis;
5. Patients hypersensitive to opioids;
6. Patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 fold of upper limit of normal value, or liver function of Child C grade;
7. Patients who cannot take drugs orally;
8. Patients with an incoercible nausea or vomiting;
9. Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;
10. Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;
11. Those with opioid addiction;
12. Alcoholic patients;
13. Those with cognitive dysfunction;
14. Those with severe depression;
15. Patients with other conditions or reasons causing the patients unable to complete the clinical trial. | 37,819 |
Study Objectives
Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy before and after surgery. The chemotherapy regimen used in our institution, called DCF (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia relief. however, it is toxic, causing approximately half of patients severe inflammation of the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting and diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at least equally active, but less toxic.
Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to proceed with the next trial, a randomized comparison of DCF and FLOT
Conditions: Gastric Adenocarcinoma, Esophageal Adenocarcinoma
Intervention / Treatment:
DRUG: FLOT (5-fluorouracil, oxaliplatin, docetaxel)
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction (GEJ), or lower third of the esophagus.
* The tumor must be deemed by the team to be potentially resectable. This includes imaging studies (detailed below) to clinically stage the tumor and rule out the presence of metastatic disease, and includes a preoperative laparoscopic evaluation.
* Stage IB (T1N1 only), II, IIIA, IIIB, and IV (T4N1 only)
* Life expectancy greater than 3 months
* ECOG performance status of 0-2 (i.e. restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work).
* Adequate hematologic reserve: Platelet count greater than or equal to 100,000 microlitre, WBC greater than or equal to 2000 microlitre,
* Creatinine clearance greater than or equal to 30 ml/min, AST \& ALT less than or equal to 2 ULN, Alkaline phosphatase less than or equal to 2.5 ULN, bilirubin less than or equal ULN
Exclusion Criteria:
* Prior systemic therapy for gastric cancer
* Prior docetaxel-containing chemotherapy
* Pre-existing medical conditions precluding treatment, including any contraindication for major surgery
* Pregnancy or lactating mothers. Women of childbearing age must use contraception during and for 3 months following treatment
* Inability to give informed consent
* Inability to maintain nutrition by oral consumption of food alone must have additional enteral feeding.
* Macroscopic disease noted at laparoscopy
* ECOG peformance status of 3 or higher
* Unwillingness to undergo investigations and/or treatment as outlined on the study | 5,311 |
Study Objectives
Purpose: To conduct a one-arm phase II trial to: (1) compare changes in pre- to post-chemotherapy cognitive function in a cohort of patients with breast cancer receiving memantine to historical controls; (2) examine how depression, anxiety, fatigue, baseline Intelligence Quotient (IQ), and cognitive effort relate to objective and self-reported cognitive function; and (3) estimate the feasibility of conducting a clinical trial of memantine for attenuating cognitive decline in patients with breast cancer during chemotherapy.
Participants: Adult patients with stage I-III breast cancer scheduled for adjuvant or neoadjuvant chemotherapy.
Procedures (methods): Cognitive assessments will be performed within one week of initiating and four weeks after completion of chemotherapy. Patients will receive memantine 10 mg twice daily between the pre- and post-chemotherapy study assessments. Cognitive function will be assessed objectively using a computerized cognitive test (Delayed Matching to Sample (DMS) test) and a standard neuropsychological battery. To assess subjective cognitive function, the Patient Reported Outcome Measurement Information System (PROMIS) Cognitive Function measure will be used. Depression, anxiety, fatigue, menopausal status, and sleep will be assessed as covariates.
Conditions: Cognitive Decline, Chemo-brain
Intervention / Treatment:
DRUG: Memantine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: PREVENTION
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Able to provide informed consent
* At least 18 years of age
* Able to speak English
* Diagnosed with breast cancer, Stages I-III
* Scheduled for adjuvant or neoadjuvant chemotherapy
Exclusion Criteria:
* A history of adverse reaction to memantine
* Another cancer diagnosis with an estimated survival of less than five years
* Previous chemotherapy exposure
* Severe cognitive impairment, defined as Blessed Orientation Memory Concentration Test (BOMC) ≥ 11.
* Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment, or breastfeeding
* Current alcohol or drug abuse | 2,433 |
Study Objectives
Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose of this study is to test a stepped-care approach tailored to symptom severity based on recent American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community oncology settings and to examine intervention costs. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.
Conditions: Anxiety, Depressive Symptoms, Sleep Disturbance, Recurrent Disease, Fatigue, Quality of Life, Cancer
Intervention / Treatment:
OTHER: Severe Anxiety/depression: High Intensity Stepped Care, OTHER: Moderate Anxiety/depression: Low Intensity Stepped care, OTHER: Enhanced Usual Care Control
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:
* Age ≥18 years
* Score ≥10 on the GAD-7 and/or a score ≥8 on the PHQ-9, indicating clinically significant anxiety or depressive symptoms, respectively.
* Past history of treated Stage I, II, or III (newly diagnosed or recurrent) breast, colorectal, prostate, gynecologic (to include uterine and cervical) cancers and non-Hodgkin's lymphoma.
* 6-60 months post-treatment (surgery, chemotherapy, and/or radiation therapy) for cancer. Time frame applies to most recent completion of treatment if participant had a cancer recurrence. It is acceptable to be on maintenance or hormonal therapies.
* Participant resides in California, Georgia, Illinois, Kansas, Michigan, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, Tennessee, or Wisconsin
* Study-trained therapist in the state where the participant resides.
* Must be able to speak and understand English.
* Must have access to a telephone
Exclusion Criteria:
* Current psychotherapy \[regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days prior to randomization\].
* Self-reported active alcohol or substance abuse within the last 30 days.
* Past history of prostate cancer or non-Hodgkin's lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy).
* Diagnosis of a second malignancy (except for non-melanoma skin cancers) after a previous diagnosis of breast, colorectal, gynecologic cancers and non-Hodgkin's lymphoma
* Progressive cancer (must be considered no evidence of disease or stable)
* Self -reported history of a diagnosis of dementia from a healthcare provider.
* Self -reported psychotic symptoms in the last 30 days prior to randomization
* Active suicidal ideation (currently reported suicidal plan and intent).
* Any change in psychotropic medications within the last 30 days.
* Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff)
* Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the course of the study. | 769 |
Study Objectives
Pain in cancer patients is estimated to be as high as 90% and results in physical and psychological disability. Behavioral interventions that increase patients' confidence in their ability to manage their pain have been shown to be beneficial. Behavioral interventions for cancer pain teach patients how their thoughts and feelings can influence their pain and specific strategies (e.g., relaxation) for decreasing cancer pain. However, despite guidelines recommending such interventions be used in the care of cancer patients with pain, they are not routinely used. A critical barrier to the use of behavioral interventions is that patients have difficulties attending appointments which are typically offered at the medical center during normal business hours. Mobile health (mHealth) technologies provide new opportunities to decrease such barriers. The investigators have developed a new mHealth approach that may increase the use of behavioral cancer pain interventions and ultimately lead to greater use of interventions that can decrease pain and disability.
The investigators propose to test an approach that uses mHealth technologies to deliver a behavioral cancer pain intervention to patients in their home using a tablet computer (e.g., iPad) and video-conferencing (e.g., Skype). The investigators will randomly assign 160 cancer patients with breast, lung, prostate, or colorectal cancer pain to receive either mHealth Pain Coping Skills Training system (mPCST) or to receive a traditional in-person pain coping skills training intervention protocol (PCST-trad) at the medical center. The investigators will test whether the mPCST is more accessible to patients than PCST-trad. The investigators expect that mPCST, compared to PCST-trad, will: a) be more feasible meaning that more patients will complete it in a timely manner; b) create less burden meaning it is easier for patients physically, emotionally, and financially to participate; c) increase engagement meaning that patients will practice skills more and have more understanding of the material; and d) be more overall acceptable to patients. the investigators also expect that patients who find this intervention more feasible, less burdensome, more engaging, and more acceptable will be more likely to experience decreased pain, physical disability, and psychological disability, and increased confidence in their ability to manage their pain.
The investigators' goal is to use mHealth technologies to facilitate wide-spread use of behavioral cancer pain interventions. Increased use of mHealth behavioral cancer pain interventions will particularly benefit patients living far from medical centers (e.g., rural), experiencing cancer-related physical challenges, and facing other practical barriers (e.g., transportation, work) to in-person interventions. These outcomes could lead to future work evidencing that mHealth behavioral interventions could be applied to other areas of quality of life in cancer patients (e.g., fatigue) and/or in other samples of patients with persistent pain (e.g., arthritis).
Conditions: Mobile Pain Coping Skills Training, In Person Pain Coping Skills Training
Intervention / Treatment:
BEHAVIORAL: Pain Coping Skills Training
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Life expectancy of 6 or more months
* Clinical pain rating of 3/10
* Primary diagnosis of breast, lung, prostate, or colorectal cancer in last year
Exclusion Criteria:
* Cognitive impairment
* Metastases to brain
* Treatment for serious psychological disorder in last 6 months
* Current or past engagement in pain coping skills training for cancer pain | 1,685 |
Study Objectives
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.
Conditions: Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors, Chordoma, Meningioma, Schwannoma, Neurofibroma, Paragangliomas, Arteriovenous Malformations
Intervention / Treatment:
RADIATION: SBRT for Benign Extradural Spine Tumors, RADIATION: SBRT for Vertebral/Paraspinal Metastases
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Eligibility Criteria:
* Patient age \>= 18 years
* performance status of 0-3
* Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
* Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
* Established histologic diagnosis of a benign or malignant tumor of the spine.
* Arteriovenous malformation of the spine identified radiographically (no biopsy)
* Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal segment
* Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor should not be within 5 mm of the spinal cord.
* If chemotherapy is planned, ideally it should not have been given within 30 days of starting radiation and should not resume until at least 2 weeks after completing radiation. In addition, it is not recommended to perform SBRT when targeted anti-angiogenesis therapy is planned within 2 months of the procedure.
* Signed study-specific consent form
Exclusion Criteria:
* Lesion involving \> 3 adjacent vertebral levels
* Overt spinal instability
* Neurologic deficit due to bony fragments/bony compression of neural structures
* Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous radiation exposure at the involved level(s)
* Rapidly progressive spinal cord compromise or neurological deficit
* Paralysis, or otherwise compromised motor function due to radiographically confirmed cord compression
* Patient unable to undergo an MRI
* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent | 41,090 |
Study Objectives
In this evaluation, 3 different versions of mailers promoting annual mammograms are being sent to women on the month of their 50th and 64th birthdays. The researchers hypothesize that the use of behavioral nudges in the mailers should lead to increased uptake in mammogram screening.
Conditions: Breast Cancer
Intervention / Treatment:
BEHAVIORAL: Postcard, BEHAVIORAL: Small Gift, BEHAVIORAL: Loss Frame and Fear Appeals
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: DOUBLE | Inclusion Criteria:
* Female Geisinger Health Plan members turning 50 and 64 in that month
* For the 2020 campaign, birthdays from June 2020 (as opposed to August 2020) will be included due to a temporary suspension of the outreach program due to the COVID-19 pandemic since June
* For the pre-post examination of the 2019 campaign, all months in that year will be included
Exclusion Criteria:
- Members who are on the do not contact list at Geisinger Health Plan | 16,023 |
Study Objectives
Investigation of maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992
Conditions: Neoplasms
Intervention / Treatment:
DRUG: BIBW 2992
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Male or female patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid tumors, of types historically known to express EGFR and/or HER2 (Human Epidermal Growth Factor Receptor), who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment preferably patients with breast, colorectal or prostate cancer
* Age 18 years or older
* Life expectancy of at least three (3) months
* Written informed consent that is consistent with International Conference on Harmonization - Good Clinical Practice guidelines
* Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2
* Patients recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC \<=Grade 1
* Patients must be recovered from previous surgery
The 12 additional patients recruited at the MTD must also meet the following criteria:
* Measurable tumor deposits (RECIST) by one or more techniques (X-ray, CT, MRI) and/or recognized tumor markers such as prostate-specific antigen (PSA) (prostate cancer) or cancer antigen (CA) 125 (ovarian cancer)
Exclusion Criteria:
* Active infectious disease
* Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea
* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
* Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least eight (8) weeks, no history of cerebral edema or bleeding in the past eight (8) weeks and no requirement for steroids or anti-epileptic therapy
* Cardiac left ventricular function with resting ejection fraction CTC \>=Grade 1
* Absolute neutrophil count (ANC) less than 1500/mm3
* Platelet count less than 100 000/mm3
* Bilirubin greater than 1.5 mg /dl (\>26 μmol /L, SI unit equivalent)
* Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
* Serum creatinine greater than 1.5 mg/dl (\>132 μmol/L, Système Internationale unit equivalent)
* Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
* Pregnancy or breast-feeding
* Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (excluding Luteinizing Hormone-Releasing Hormone (LHRH) agonists, or other hormones taken for breast cancer, or bisphosphonates), or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
* Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (eight weeks for trastuzumab)
* Patients unable to comply with the protocol
* Active alcohol or drug abuse
A patient may be eligible for re-treatment after the previous course is finished. A patient will not be eligible if any of the following conditions are met:
* Patients with clinical signs of disease progression or if latest X-ray, CT or MRI reveals disease progression
* Cardiac left ventricular function CTC Grade ≥ 2 at any time during the previous course
* Patients fulfilling any of the Exclusion Criteria (except criterion 5) listed before as determined
* On Day 28 of treatment period 1 or on Visit R1 of the current course when patient is entering the repeated treatment period (treatment period 2),
* On Visit R5 of the previous course or on Visit R1/C1 of the current course when patient is in repeated treatment period (treatment courses 3 to 6) or when entering continuous treatment period (treatment course 7), or
* On Visit C3 of the previous course or Visit C1 of the current course when patient is in continuous treatment period (treatment courses 8 to final discontinuation)
* Patient not recovered from any dose-limiting toxicity (DLT) 14 days after the last administration of BIBW 2992 in the previous course. Recovery is defined as return to baseline level or CTC Grade 1, whichever is higher | 44,131 |
Study Objectives
This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous \[IV\] and 14 cycles of SC trastuzumab).
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Trastuzumab, DRUG: Paclitaxel, DRUG: Docetaxel
Location: Belarus, Kazakhstan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Hormonal therapy allowed as per institutional guidelines
* Left ventricular ejection fraction (LVEF) of greater than or equal to (\>/=) 55 percent (%) measured by echocardiography (ECHO) prior to first dose of trastuzumab
* HER2-positive disease immunohistochemistry (IHC) 3+ or in-situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
* Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
* No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
* Participants who have completed all (neo)adjuvant treatment or participants after adjuvant chemotherapy with doxorubicin and cyclophosphamide (AC) to whom the 4 subsequent cycles of trastuzumab in combination with paclitaxel or docetaxel are indicated per local practice
* Not more than 3 months should have elapsed since the last dose of adjuvant chemotherapy in case of subsequent treatment scheme
Exclusion Criteria:
* Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
* History of other malignancy that can affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and participants with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study
* Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
* Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
* Prior maximum cumulative dose of doxorubicin \>360 mg/m2 or maximum cumulative dose of epirubicin \>720 mg/m2 or equivalent
* Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
* Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Pregnant or lactating women
* Concurrent enrollment in another clinical trial using an investigational anticancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
* Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin®, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g., difficult to control asthma
* Inadequate bone marrow, hepatic, or renal function
* Major surgical procedure or significant traumatic injury within 14 days prior to the first dose of study treatment or anticipated need for major surgery during the course of study treatment | 21,962 |
Study Objectives
The investigators aim is to study the efficacy of mentholyptus drops in improving the palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study is a randomized controlled trial which will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. Patients assigned to the intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while drinking the PEG solution unlike the control arm patients who will only receive the PEG solution. All patients will then be evaluated for the tolerability of the preparation while taking into account the palatability of the solution as main outcome and the remaining volume of the PEG solution and side effects as secondary outcomes.
Conditions: Colon Cancer
Intervention / Treatment:
OTHER: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®), OTHER: PEG solution (Fortrans®)
Location: Lebanon
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose:
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* elective colonoscopy
* consent to the study
Exclusion Criteria:
* pregnant or lactating women
* age less than 18 years
* significant gastroparesis
* gastric outlet obstruction
* ileus
* known or suspected bowel obstruction or perforation
* phenylketonuria
* glucose-6-phosphate dehydrogenase deficiency
* severe chronic renal failure (creatinine clearance \<30 mL/minute)
* severe congestive heart failure (NYHA class III or IV)
* dehydration
* severe acute inflammatory disease
* compromised swallowing reflex or mental status
* uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
* toxic colitis or megacolon
* previous colonoscopy within the last 5 years
* active Inflammatory bowel disease
* previous colectomy or partial colectomy | 37,194 |
Study Objectives
This is a phase 1 study of sildenafil in combination with regorafenib in patients with progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted for the dose escalation of the treatment combination: additional patients will be enrolled at the MTD until a total of 12 patients have been treated at the MTD.
Conditions: Solid Tumor
Intervention / Treatment:
DRUG: Regorafenib, DRUG: Sildenafil Citrate
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:
• Advanced solid tumor that has progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
* Note: patients with solid tumors for which regorafenib would be considered a standard treatment are eligible as long as regorafenib has not been previously administered
* Measurable or evaluable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelets \>= 100,000/mm\^3
* Hemoglobin \> 9 g/dL (untransfused)
* Creatinine =\< 1.5 x upper limit of normal (ULN) for the laboratory or calculated or actual creatinine clearance \>= 60 mL/min
* Proteinuria =\< grade 1 (ie, =\< 1+ \[30 mg/dL\] using a random urine sample or \< 1.0 gm using a 24-hour sample)
* Note: if urine sample indicates \>= grade 2 proteinuria (ie, 2+ \[100 mg/dL\]), a 24-hour urine sample must be collected and tested; urine protein in the 24-hour sample must be \< 1.0 gm/24 hours • Total bilirubin =\< 1.5 x ULN for the laboratory
* Exception: if a patient has documented Gilbert's syndrome and a total bilirubin is \> 1.5 x ULN, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL) for the laboratory
* Aspartate aminotransferase (AST) =\< 2.5 x ULN for the laboratory
* Alanine aminotransferase (ALT) =\< 2.5 x ULN for the laboratory
* Alkaline phosphatase =\< 2.5 x ULN for the laboratory (=\< 5 x ULN for patients with cancer involving the liver and/or bone)
* Non-hematologic toxicities from previous cancer therapies resolved to =\< grade 1
* International normalized ratio (INR) is =\< 1.5
* Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN for the laboratory
* Left ventricular ejection fraction (LVEF) assessed by echocardiogram within 3 months prior to initiation of study treatment indicates an LVEF of \>= 50%
* A woman of childbearing potential (WCBP), defined as a woman who is \< 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
* A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for 2 months following completion of study treatment
* Ability to understand and willingness to sign the consent form written in English
* Note: the consent form must be signed prior to the conduct of any trial-specific procedure
Exclusion Criteria:
* Meningeal metastases or brain metastases that are symptomatic or untreated \* Note: patients who are asymptomatic and have had post-treatment imaging that indicates stable brain disease are eligible; (patients with meningeal metastasis are not eligible even if stable following treatment); also, note that brain imaging is required within 8 weeks prior to initiation of study therapy
* Any investigational agent within 4 weeks prior to initiating study treatment
* Previous therapy with regorafenib
* If sorafenib was previously administered, intolerance to sorafenib
* Inability to swallow medication
* Known or suspected malabsorption condition or obstruction
* Contraindications to sildenafil including:
* Known retinitis pigmentosa
* History of priapism related to PDE5 inhibitors (eg, sildenafil, vardenafil, tadalafil)
* Presence of nonmalignant hematologic disorders, such as sickle cell disease, that may increase the risk of priapism
* Contraindication to antiangiogenic agents, including:
* Serious non-healing wound, non-healing ulcer, or bone fracture
* Major surgical procedure or significant traumatic injury within 4 weeks prior to initiating study treatment
* Pulmonary hemorrhage/bleeding event \>= grade 2 within 12 weeks prior to initiating study treatment
* Any other hemorrhage/bleeding event \>= grade 3 within 12 weeks prior to initiating study treatment
* History of organ allograft including corneal transplant
* Any documented history of thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism within 6 months prior to initiating study treatment
\* Note: patients with a tumor-associated thrombus of locally-involved vessels should not be excluded from participating in the study
* Evidence of bleeding diathesis or coagulopathy
* Resting systolic blood pressure (BP) \< 100 mmHg
* Hypertension defined as systolic BP \>= 140 mmHg or diastolic BP \>= 90 mmHg despite optimal medical management
* Active or clinically significant cardiac disease including any of the following:
* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
* Myocardial infarction within 6 months prior to initiating study treatment
* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
* New York Heart Association (NYHA) class III or IV congestive heart failure
* Seizure disorder requiring medication
* Serious (ie, \>= grade 3) uncontrolled infection
* Known human immunodeficiency virus (HIV) seropositivity
\* Note: HIV testing is not required
* Chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
* Pleural effusion or ascites that causes respiratory compromise (ie, \>= grade 2 dyspnea)
* Untreated or metastatic pheochromocytoma
* Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment, for example:
* Alpha 1-blockers
* Vasodilators, such as nitrates
* Other PDE5 inhibitors, eg, vardenafil, tadalafil
* Therapeutic anticoagulation with vitamin K antagonists (eg, warfarin), heparins and heparinoids, or direct thrombin inhibitors (DTIs) \*\* Note: prophylactic low-dose anticoagulation to maintain vascular access devices or low-dose daily aspirin for cardiac health is permitted
* Immunosuppressants such as tacrolimus, leflunomide or tofacitinib, roflumilast, pimecrolimus
\*\* Note: administration of steroids as part of symptom management or for other supportive care purposes is permitted
* STRONG cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or STRONG CYP3A4 inducers \*\* Note: if such medications have been used, patients must have discontinued these agents \>= 2 weeks prior to initiating study treatment
* Pregnancy or breastfeeding
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements | 16,850 |
Study Objectives
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
Conditions: Liver Cancer
Intervention / Treatment:
BIOLOGICAL: bevacizumab, DRUG: sorafenib tosylate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed hepatocellular carcinoma
* Locally advanced or metastatic disease that is not amenable to treatment with surgery or to orthotopic liver transplant
* Child Pugh class A or B7 disease
* Measurable disease
* No mixed cholangiocarcinoma/hepatocellular carcinoma
* No current or previously resected brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* ANC ≥ 1,200/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 5 times ULN
* Alkaline phosphatase ≤ 5 times ULN
* Urine protein ≤ 1+ by urine protein:creatinine ratio OR 24-hour urine protein \< 1 g
* QTc interval ≤ 500 msec on baseline EKG
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 2 weeks after sorafenib tosylate and 6 months after bevacizumab
* None of the following risk factors for decreased LVEF:
* Prior treatment with anthracyclines
* History of myocardial infarction within the past 12 months
* No uncontrolled hypertension (defined as systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
* No New York Heart Association class III-IV congestive heart failure
* No cardiac ventricular arrhythmias requiring antiarrhythmic therapy
* No history of hypertensive crisis or hypertensive encephalopathy
* No cardiac ventricular arrhythmia requiring anti-arrhythmic therapy within the past 6 months
* None of the following within the past 6 months:
* Transient ischemic attack
* Cerebrovascular accident
* Unstable angina or angina
* Clinically significant peripheral artery disease (i.e., claudication in less than one block) or any other arterial thrombotic event
* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
* Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis
* No active or recent history of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
* No evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation)
* No significant traumatic injury within the past 4 weeks
* No serious or non-healing wound, ulcer, or bone fracture
* No uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
* No other active malignancy within the past 3 years, except nonmelanotic skin cancer or carcinoma in situ of the cervix
* No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or sorafenib tosylate
PRIOR CONCURRENT THERAPY:
* No prior systemic chemotherapy regimens for hepatocellular carcinoma
* No prior external beam radiation to the primary site
* No prior central thoracic radiation therapy (RT), including RT to the heart
* No prior radiation (if given for another malignancy) to ≥ 25% of the bone marrow
* At least 6 weeks since prior chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies
* More than 4 weeks since prior biologic, hormonal, or immune therapy
* More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
* More than 7 days since prior core biopsy or other minor surgical procedure (placement of a vascular access device allowed)
* No concurrent investigational agent which would be considered as a treatment for the primary neoplasm
* No concurrent anticoagulants, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis
* No other concurrent treatment for prior malignancy (other than hormonal therapy) | 6,265 |
Study Objectives
Background:
- TRC105 is an experimental cancer drug. It is designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. People with hepatocellular carcinoma (or liver cancer) sometimes do not respond to standard treatments. This includes the cancer drug sorafenib.
Objectives:
- To test the safety and effectiveness of TRC105 to treat liver cancer that has not responded to standard therapy.
Eligibility:
* People at least 18 years of age who have hepatocellular carcinoma (or liver cancer) that has not responded to standard therapy. Participants also will not be eligible for a liver transplant.
* No anticoagulation therapy is allowed with the exception of low-dose aspirin.
* No history of bleeding disorders, peptic ulcer disease or gastritis.
Design:
* Participants will have a physical exam and medical history. They will also have blood and urine tests, and imaging studies.
* Participants will receive TRC105 once a week. They will also have two daily doses of a steroid the day before each treatment. This will help prevent known side effects.
* Participants will be monitored with blood and urine tests. They will also have imaging studies every two months to study the effect of the drug on tumor growth.
* Participants will continue to have TRC105 as long as they do not have severe side effects and their liver cancer stops growing or shrinks. After stopping TRC105, they will have yearly visits with physical exams and blood tests.
Conditions: Hepatocellular Carcinoma, Hepatocellular Cancer, Carcinoma, Hepatocellular
Intervention / Treatment:
DRUG: TRC105
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 histopathological confirmation of Hepatocellular Carcinoma (HCC) by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this study.
Or
histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of HCC.
* Patients must have disease that is not amenable to potentially curative resection or ablative techniques. In addition, disease must not be amenable to transhepatic arterial chemoembolization (TACE). Patients may have had prior TACE and had disease progression following it. Patients must not be considered potential candidates for liver transplantation. This determination will be made after hepatobiliary surgical input at the NCI multidisciplinary conference.
* All patients enrolled will be required to have measurable disease.
* If liver cirrhosis is present, patient must have a Child-Pugh A classification.
* Patients must have progressed on or been intolerant of prior sorafenib therapy.
* Patients must with cirrhosis have had esophagogastric endoscopy within the previous 6 months prior to study entry for the assessment of varices. If the patient has not had this done they must be willing to undergo this procedure prior to study entry.
* Age greater than or equal to 18 years
* Life expectancy of greater than 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have normal organ and marrow function as defined below:
* Absolute neutrophil count greater than or equal to 1,500/mcL
* Platelets greater than or equal to 60,000/mcL
* Total bilirubin less than or equal to 3 times upper normal limits
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to 10 times upper limit of normal
* Creatinine less than or equal to 1.5 times upper normal limits OR creatinine clearance greater than or equal to 40 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula.
* Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be less than or equal to grade 1 or returned to baseline.
* Patients must not have other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers, carcinoma in situ of the cervix and noninvasive bladder cancer).
* Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 3 months after the end of the treatment.
* Patient must be able to understand and willing to sign a written informed consent document.
EXCLUSION CRITERIA:
* Patients who have had chemotherapy, large field radiotherapy, or major surgery must wait 4 weeks prior to entering the study (2 weeks is sufficient for targeted systemic therapy provided toxicity has recovered to less than or equal to grade 1).
* Patients may not be receiving any anti-cancer agents not approved by the Food and Drug Administration (FDA) within the past 4 weeks.
* Patients with known brain metastases will 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.
* Proteinuria, as demonstrated by a 24 hour protein of greater than or equal to 2000 mg. Urine protein will be screened by urine protein-creatinine ratio (UPC). For urine protein-to-creatinine (UPC) ratio \> 1.0, a 24-hour urine protein will need to be obtained and the level should be \< 2000 mg for patient enrollment.
* Uncontrolled intercurrent illness including, but not limited to, hypertension (systolic blood pressure (BP) 160, diastolic BP \> 100), ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
* No anti-coagulation therapy is allowed with the exception of low-dose aspirin.
* No bleeding diathesis.
* Patients with a history of bleeding varices in previous 1 year are excluded (unless patient has subsequently had a liver transplant). Those with gastric varices or varices that are deemed as high risk by the endoscopist should be placed on appropriate medical therapy as advised by the gastroenterologist.
* History of peptic ulcer disease or hemorrhagic gastritis within 6 months of TRC105 administration, unless patient has received adequate treatment for peptic ulcer disease or hemorrhagic gastritis and has evidence of complete resolution documented by esophagogastroduodenoscopy (EGD). Mild gastritis is allowed.
* Corrected QT interval (QTc) \> 500 msec.
* Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral therapy are excluded from this study due to the possibility of pharmacokinetic interactions between antiretroviral medications and TRC105. HIV positive patients not receiving antiretroviral therapy are excluded due to the possibility that TRC105 may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events with respect to TRC105.
* History of hypersensitivity reaction to human or mouse antibody products.
* Patients with a history of familial bleeding disorders.
* Patients with a history of hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome).
* Pregnancy and breast feeding are exclusion factors. Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 3 months after the end of the treatment.
INCLUSION OF WOMEN AND MINORITIES:
-Men and women of all races and ethnic groups are eligible for this trial. | 11,284 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma (cancer) of unknown primary origin.
Conditions: Carcinoma of Unknown Primary, Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: fluorouracil, DRUG: irinotecan hydrochloride, DRUG: leucovorin calcium, PROCEDURE: conventional surgery, RADIATION: radiation therapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Histologically proven previously untreated stage III or stage IV colorectal carcinoma
* Other carcinomas refractory to standard treatment
* Metastatic adenocarcinoma of unknown primary site
PATIENT CHARACTERISTICS:
Age:
* Under 25
Performance status:
* ECOG 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Hemoglobin at least 10.0 g/dL
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Albumin greater than 3.0 g/dL
* Bilirubin less than 1.5 mg/dL
* SGOT or SGPT less than 2 times normal
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 80 mL/min
* Urinalysis normal
Other:
* Blood glucose normal
* Electrolytes normal
* Prior curatively treated childhood cancer allowed
* Weight greater than 10th percentile for height
* Not pregnant or nursing
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified | 44,732 |
Study Objectives
This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: SGN-40, DRUG: lenalidomide, DRUG: dexamethasone
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:
* Diagnosis of multiple myeloma.
* Received at least one prior systemic therapy other than single-agent corticosteroids.
* Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free light chain (FLC) in serum as determined by serum FLC assay and provided the serum FLC ratio is abnormal.
Exclusion Criteria:
* Received an allogenic stem cell transplant.
* Previous intolerance of lenalidomide or dexamethasone.
* Primary invasive malignancy (other than multiple myeloma) within the last 3 years. | 38,158 |
Study Objectives
This trial studies the use of genetics and shared decision making in improving care for patients with stage IVA-C non-small cell lung cancer. Developing educational tools may help patients with non-small cell lung cancer to increase patient treatment knowledge, reduce decisional conflict, and promote treatment shared decision making with their health care providers.
Conditions: Activating ALK Gene Mutation Negative, Activating EGFR Gene Mutation Negative, Activating ROS1 Gene Mutation Negative, Health Care Provider, Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Intervention / Treatment:
OTHER: Counseling, OTHER: Questionnaire Administration, OTHER: Medical Chart Review
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:
* Newly diagnosed with advanced NSCLC (stage IV a-c) that are wild-type for activating genetic alterations (EGFR, ROS 1, and ALK).
* May or may not be candidates for immune checkpoint therapy.
* May have had 1-any number of prior systemic therapy regimens.
* If prior systemic regimen, must have progression disease at time of evaluation.
* Untreated brain metastases permitted.
* Completed pathological analysis of tumor tissue.
* Patients who have exhausted targeting therapy options.
* Can speak and read English.
* All participants must be willing to comply with all study procedures and be available for the duration of the study.
* Providers: Those who treat NSCLC patients as described above.
Exclusion Criteria:
• There are no specific exclusions in this trial for particular medical conditions, comorbidities, or performance status. Any patient deemed appropriate to be considered for evaluation and/or treatment would be appropriate to include in this trial. | 860 |
Study Objectives
Serious side effects occurs with disease and treatments in survival after lung cancer. For this reason, functional capacity, cognitive status, pain perception and respiratory functions may be affected in lung cancer. The purpose of this study was to evaluate respiratory function, respiratory muscle strength and endurance, functional capacity, pain, cognitive status level, and physical activity in lung cancer patients and compare with the findings of healthy subjects
Conditions: Lung Neoplasm, Survivorship
Intervention / Treatment:
DIAGNOSTIC_TEST: Functional capacity
Location: Turkey
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Cooperation
* lung cancer patients who had a stable condition
Exclusion Criteria:
* Active cancer treatments
* Brain metastasis story
* Any orthopedic disease impairs walking, balance | 15,795 |
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