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Study Title Principal Investigator
0C-11-1 Ph1-66 Phase I Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction
Belinostat looks promising for the treatment of patients with cancer, having activity in several tumor types as a single therapy and in combination. Exploring appropriate dosing for patients with varying degrees of abnormal liver function would benefit patients with many diseases. Belinostat is broken down in the liver and is also excreted primarily through the liver. Therefore, belinostat dosing in patients with abnormal liver function will be explored in this phase I clinical trial to establish dosing guidelines. The primary objectives of this study in patients with varying degrees of liver function are to establish safety and tolerability of belinostat given on days 15 of 21-day cycles, define the maximum tolerated dose (MTD) and recommended dose of belinostat given on days 15 of 21-day cycles, and to evaluate the drug levels (pharmacokinetics (PK)) of one dose of belinostat (400 mg/m2).Patients will be divided into four groups according to their liver function: normal liver function (Cohort 1), mild abnormal liver function (Cohort 2), moderate abnormal liver function (Cohort 3), and severe abnormal liver function (Cohort 4). Patients will have screening tests/procedures done to see if they are eligible for the study. Once they are deemed eligible, they will be assigned to one of the cohorts. Participants will be given belinostat through a vein in their arm for 30 minutes. They will take the study drug on Days 1-5 during each 21 day cycle, except for cycle 1. On Day -7, cycle 1, participants will receive an extra dose of belinostat and have PK blood draws done at the Clinical Trials Unit. During each cycle, they will have a physical exam, vital signs, assessment of performance status, blood draws, assessment of their tumor with radiographic scans, monitoring for compliance to treatment and monitoring for side effects. Patients will continue the treatment until their disease worsens, they cannot tolerate the side effects, they are physically unable to continue, at the decision of the study doctor, or they decide to withdraw from the study. Participants will be followed for 30 days after the last dose is given or until one of the following occurs: they enroll on another study (phase 0 or early phase I), they receive standard of care, or death, whichever comes first. The follow-up will consist of a phone call between Days 27-30 after the last dose to evaluate side effects that were ongoing and any new events that might be related to the therapy. Unacceptable side effects related to the study drug that have not resolved by Day 30 post-treatment will be followed through twice weekly phone calls until they stabilize or resolve. Participants will be removed from study for one of the following reasons: completed 30-day followup period, side effects are unresolved but stabilized, they enroll on another study (phase 0 or early phase I), or receive standard of care. The study uses a 3+3 design. A minimum of 2 and a maximum of 6 participants will be accrued in each abnormal liver function Cohort (2-4) at each dose level, and 12 patients will be entered at the recommended dose level in Cohort 1. MTD will not be established for the normal cohort as that is already known. Three additional patients will be accrued to the MTD levels (following establishment of MTD for that cohort in the first 6 patients at that dose level) for each abnormal liver function cohort to allow additional information to be gained at these levels. Some patients may need to be replaced if they are not evaluable based on protocol guidelines. As long as < 33% of the patients treated at a given dose level experience a dose limiting side effect, that dose level will be considered the MTD.
Recruiting | Lymphoma | Multisite
Heinz-Josef Lenz
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An Open-label, Randomized Phase 3 Study Of Inotuzumab Ozogamicin Compared To A Defined Investigator's Choice In Adult Patients With Relapsed Or Refractory Cd22-positive Acute Lymphoblastic Leukemia (All)
Recruiting | Leukemia | Multisite
3C-14-1: A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer
This is a Phase 2 open-label, multi-center, 2-stage Simon design stage trial of nivolumab (BMS-936558) monotherapy (mStage) or in combination with ipilimumab (cStage) to estimate the response rate in Metastatic Microsatellite MSI-High colon cancer. Ipilimumab is a fully humanized IgG1 monoclonal antibody binding to the anti-cytotoxic T-cell lymphoma-4 antigen (CTLA-4). Ipilimumab is an approved therapy for metastatic melanoma.Nivolumab (BMS-936558; anti-PD-1 mAb) is a fully human monoclonal immunoglobulin (Ig) G4 antibody that binds to the programmed death-1 (PD-1), a negative regulatory molecule expressed by immune cells.Primary Objective of the study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with metastatic MSI-H colon cancer.The study will also contain a safety cohort of subjects with non-MSI-H colon cancer to assess the safety and tolerability of nivolumab in combination with ipilimumab in subjects with non-MSI-H colon cancerBoth Arms N and N+I will follow a two-stage design to test whether nivolumab monotherapy or nivolumab combined with ipilimumab yields an objective response rate (ORR) that is of clinical interest in MSI-H metastatic colorectal cancer mCRC. On treatment stages that meet an ORR threshold will proceed from Stage 1 to Stage 2 (same for both m and cStage). The primary endpoint of this study ORR which is based on tumor assessments at baseline and then at 6 weeks from first dose and continue every 6 weeks for the first 24 weeks and every 12 weeks thereafter until disease progressionThe study will enroll 96 patients out of which 15 will be enrolled at USC
Recruiting | Colon / Rectal Cancer | Multisite
Heinz-Josef Lenz
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13NHL-14-3: Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of lenalidomide (CC-5013) plus R-Chop Chemotherapy (R2-Chop) versus Placebo plus R-Chop Chemotherapy in Subjects with Previously Untreated Activated B-Cell Type Diffuse Large B-Cell Lymphoma
This randomized, placebo controlled study is designed to evaluate the efficacy and safety of R2-CHOP chemotherapy versus placebo-R-CHOP chemotherapy in previously untreated ABC typeDiffuse Large B-Cell Lymphoma (DLBCL). The study is divided into the Screening Period, Treatment Period, and Follow-up Period. There is biological possibility and also preclinical data that provide strong support for whylenalidomide should be expected to enhance the efficacy of the current standard of care R-CHOP in the treatment of the ABC type of DLBCL. Lenalidomide suppresses the proliferation of ABCcells in DLBCLand delays tumor growth in a human mouse model. In addition, studies also show enhancement of antibody dependent cell toxicity to cancer cells. Primary objective is to evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in subjects who have previously untreated ABC type Diffuse Large B-Cell Lymphoma.Participants will receive protocol specified treatments for 6 cycles. Study treatments in a 21-day cycle are: lenalidomide / placebo Days 1 14; rituximab, cyclophosphamide, doxorubicin, and vincristine Day 1; prednisone Days 1 5Primary Endpoint is Progression-free Survival.
Recruiting | Lymphoma | Multisite
Anil Tulpule
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0C-12-1-A Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients [A8081012]
This is a research study for advanced cancer with varying degree of liver function (normal, mild impairment, moderate impairment or severe impairment). The main purposes of this research study are to see whether a newly approved drug, crizotinib (Xalkori), can be used in patients with liver function that is not normal and to see whether crizotinib can prevent or slow down your cancer from growing, and to assess any side effects that you may have. Some other purposes of this study are to measure how much crizotinib is in your blood, and to provide dosing recommendations for patients with impaired liver function. Crizotinib is approved in the United States (US) and is available by prescription for non-small cell lung cancer (NSCLC) patients with Anaplastic Lymphoma Kinase (ALK) mutation. However, the use of crizotinib in this study is experimental. Crizotinib is not currently approved to treat other advanced cancer patients with unclear ALK status and/or with liver function that is not normal. . The participants of this study will be in this study until their disease progresses (gets worse), they experience unacceptable side effects or they withdraw consent. There will be about 50 advanced cancer patients enrolled in this study. The study is being done at about 3-5 different research sites in US. About 45 participants will take part at USC. This is a multicenter, open-label, non-randomized, phase 1 study. The endpoints are how the drug behaves in the body when taken (pK), effectiveness and safety of the study drug. There will be 5 groups (Groups A1, A2, B, C and D) involved in this study. Groups A1 and A2 have normal liver functions. Group A1 will match Group B(mild) and Group A2 will match Group C(moderate).The study drug is given by mouth and should be taken at approximately the same time each day on a continuous daily dosing.One-way analysis of variance (ANOVA) will be used for statistical analysis. Individual concentration of the study drug in the blood will be listed and summarized. The safety analysis population will include all enrolled patients who receive at least one does of crizotinib. The safety analysis population will be the primary population for evaluating patient characteristics, treatment administration and safety. Safety data will be reviewed on an ongoing basis during the study.
Recruiting | Any Cancer Condition or Solid Tumor | Multisite
Anthony El-Khoueiry
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SWOG-1318 A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL
PRIMARY OBJECTIVES: I. To evaluate the 3-year survival rate in elderly patients with newly diagnosed Philadelphia (Ph)-negative acute lymphoblastic leukemia (ALL) treated with blinatumomab followed by POMP (prednisone, vincristine sulfate, methotrexate, and mercaptopurine) maintenance. II. To evaluate in a preliminary manner (feasibility study) the safety of dasatinib-steroid based induction followed by blinatumomab treatment in combination with dasatinib followed by dasatinib-based maintenance in patients with newly diagnosed Ph-positive ALL, relapsed/refractory Ph-positive ALL, and Ph-like dasatinib-sensitive mutations or kinase fusions (DSMKF) ALL (newly-diagnosed relapsed or refractory). SECONDARY OBJECTIVES: I. To evaluate toxicities in these patient populations treated with these regimens. II. To estimate the rates of complete response (CR), complete remission with incomplete count recovery (CRi) and disease-free survival in Ph-negative patients. III. To estimate disease-free and overall survival in Ph-positive ALL and Ph-like DSMKF ALL. IV. To estimate in each cohort the rate of minimal residual disease (MRD) negativity, and the time to achieve MRD negativity (exploratory analysis). V. To determine whether anti-idiotype antibodies directed against blinatumomab develop with blinatumomab treatment in this study. OUTLINE: Patients are assigned to 1 of 2 treatment cohorts according to Philadelphia chromosome status. COHORT I (PHILADELPHIA CHROMOSOME NEGATIVE PATIENTS): INDUCTION: Patients receive blinatumomab intravenously (IV) continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 courses in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone orally (PO) on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity. COHORT II (PHILADELPHIA CHROMOSOME POSITIVE PATIENTS): INDUCTION: Patients receive dasatinib PO twice daily (BID) on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 courses in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO once daily (QD) on days 1-42. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive dasatinib PO BID on days 1-28 and prednisone PO on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually until 10 years from initial registration.
Recruiting | Leukemia | Multisite
Akil Merchant
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A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
This randomized phase III trial studies how well Crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called Anaplastic Lymphoma Kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as Crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Objectives: The primary objective is to evaluate whether adjuvant therapy with Crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection. Study Population: Participants 18 years and older who have undergone complete surgical resection of their stage IB ( 4 cm), II, or IIIA NSCLC and have had negative margins. N3 disease is not allowed. Study Arms: ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Follow up: After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years. Endpoint: Overall survival (OS) is defined as the time from randomization to death from any cause. Patients that have not had an event reported at analysis will be censored at their date of last follow up. Analysis: The primary analysis will include all patients who testing positive for ALK at the central reference lab (Response Genetics), however patients with a local positive test but negative central test can still be randomized on the trial and will be included in a secondary analysis. Secondary analyses will typically include the primary analysis population. Exception to this include: analysis of toxicity data, which will include all patients from the primary analysis who received study drug regardless of eligibility.
Recruiting | Lung Cancer | Multisite
Barbara Gitlitz
CTSU-E1411: Intergroup Randomized Phase II Four Arm Study In Patients >- 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB ’ R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV’ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB ’ LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV ’ LR)
OBJECTIVES: Primary - To determine whether the addition of bortezomib (RBV) to an induction regimen of rituximab-bendamustine hydrochloride (RB) improves progression-free survival (PFS) compared to RB alone in patients ≥ 60 years of age with previously untreated mantle cell lymphoma. - To determine whether the addition of lenalidomide to a consolidation regimen of rituximab following an induction regimen of RB or RBV improves PFS compared to consolidation rituximab alone in this patient population. Secondary - To determine whether the addition of bortezomib to induction therapy improves the positron emission tomography (PET)-documented complete response (CR) rate compared to RB alone. - To determine the objective response rate (ORR) for RB and RBV. - Among patients who do not have PET-documented CR at the end of induction, to determine whether the addition of lenalidomide to consolidation therapy improves CR and ORR compared with rituximab alone. - To determine overall survival (OS) in the treatment arms. - To determine safety, with attention to the addition of bortezomib in the induction regimen and lenalidomide-rituximab (LR) as consolidation therapy. - To collect paraffin-embedded tissue for creation of tissue microarray. - To collect and bank serum and blood mononuclear cells for future studies. - To collect formalin-fixed paraffin-embedded (FFPE) tissue to analyze potential prognostic factors (Ki-67 proliferation index by immunohistochemistry and correlation with proposed 5-gene set of proliferation markers analyzed by RNA PCR; SOX 11 expression by immunohistochemistry; and Micro-RNA levels by microarray). - Using patient-reported outcomes data, to determine the extent and severity of neuropathy associated with the addition of bortezomib to induction treatment. - Using patient-reported outcomes data, to determine the extent and severity of fatigue associated with the addition of lenalidomide to consolidation treatment. - To evaluate the effects of the addition of bortezomib and lenalidomide on patient-reported health-related quality of life. - To evaluate the effects of bortezomib-related neuropathy on patient-reported health-related quality of life. - To evaluate the response of lymphoma-specific symptoms to treatment. - Using longitudinal patient-reported outcomes data, to describe the trajectory of lymphoma symptoms, neuropathy, fatigue, and overall health-related quality of life prior to, during, and following treatment among older adults with MCL. Tertiary - To assess the proportion of patients up and down staging when fludeoxyglucose F 18- (FDG) PET/CT is added to standard Ann Arbor staging. - To assess the ability of pre-treatment FDG-PET/CT (SUVmax) to predict response rate and PFS. - Among patients with interim (post-cycle 3) FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy. - To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs other, and Ki67) in the setting of MCL. - To assess differences in overall and CR rates when using Deauville vs International Harmonization Project FDG-PET/CT interpretation criteria. - To determine whether there is a correlation between FDG-PET/CT response and residual disease assessment by molecular and/or flow cytometric techniques. - To determine whether the number of malignant cells in circulation predict the number of cells in marrow. - To determine whether the number of malignant cells in circulation/in marrow at the end of induction correlate with CR and 2-year PFS. - To determine whether there is a higher rate of minimal residual disease (MRD) negativity among patients randomized to RBV as compared with RB, and among patients treated with LR maintenance compared with rituximab. - To compare the two methods of MRD detection - molecular techniques and flow cytometry - as prognostic markers for outcome. OUTLINE: This is a multicenter study. Patients are stratified according to mantle cell lymphoma International Prognostic Index risk score (low vs intermediate vs high). Patients are randomized to 1 of 4 treatment arms. - Arm A: Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm E: Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. - Arm B: Patients receive induction therapy comprising bortezomib IV or subcutaneously (SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm F: Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. - Arm C: Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm G: Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. - Arm D: Patients receive bortezomib, rituximab, and bendamustine hydrochloride as patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm H: Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo blood and bone marrow sample collection at baseline and during treatment for correlative studies. Patients complete the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym), the FACT/GOG-Neurotoxicity scale (FACT/GOG-Ntx), FACT-Fatigue, and FACT-General questionnaires at baseline and periodically during study and follow up. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 10 years.
Recruiting | Lymphoma | Multisite
Anil Tulpule
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Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes. Objective: The primary objectives are to centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies, and to obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG). Intervention: Cytology specimen collection procedure; correlative studies; cytologic sampling; and laboratory biomarker analysis. Study Population: Participants 18 years or older with stage IB-IIIA non-small cell lung cancer. Study Methodology: Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing. Follow up: After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years. Primary Endpoint: 1. Central clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105, as measured by rate of accrual [ Time Frame: Up to 4 years ] 2. Feasibility of research grade FFPE tissue collection for CCG analysis, as measured by adequate specimens collected per month [ Time Frame: Up to 4 years ] Statistics: It is estimated that up to 8000 patients may need to be genotyped in order to fully accrue to the EGFR (estimated prevalence 15%) and ALK (estimated prevalence 5%) studies. Analysis: Accrual rate to the adjuvant erlotinib and crizotinib studies will be monitored every 3 months, and discussed between the study teams coordinating the ALCHEMIST study and the adjuvant studies. If accrual is inadequate, then the ALCHEMIST study will initiate strategies to improve accrual, including opening the screening study at new centers and developing strategies for genotyping at participating centers to improve catchment.
Recruiting | Lung Cancer | Multisite
Barbara Gitlitz
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