BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
This trial is active, not recruiting.
|Start date||January 2002|
|Trial identifier||NCT00039156, BAYER-100389, CDR0000069358, SUNY-HSC-4553, THERADEX-100389|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Miami Beach, FL||Mount Sinai Comprehensive Cancer Center||no longer recruiting|
|Chicago, IL||University of Chicago Cancer Research Center||no longer recruiting|
|Shreveport, LA||Louisiana State University Health Sciences Center - Shreveport||no longer recruiting|
|Shreveport, LA||Veterans Affairs Medical Center - Shreveport||no longer recruiting|
|New Brunswick, NJ||Cancer Institute of New Jersey||no longer recruiting|
|Bronx, NY||Albert Einstein Clinical Cancer Center||no longer recruiting|
|Brooklyn, NY||HemOnCare, P.C.||no longer recruiting|
|Manhasset, NY||North Shore University Hospital||no longer recruiting|
|Syracuse, NY||State University of New York - Upstate Medical University||no longer recruiting|
|Valhalla, NY||New York Medical College||no longer recruiting|
|Memphis, TN||West Clinic||no longer recruiting|
|Seattle, WA||Seattle Cancer Care Alliance||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin||no longer recruiting|
|Edmonton, Canada||Cross Cancer Institute||no longer recruiting|
|Vancouver, Canada||St. Paul's Hospital - Vancouver||no longer recruiting|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate: - Diffuse large B-cell lymphoma - Transformed NHL - Follicular large cell lymphoma - Peripheral T cell lymphoma - Anaplastic large cell lymphoma - Mantle cell lymphoma - Unclassified aggressive histology - Immunoblastic lymphoma - Failed at least 1 prior therapy (primary resistant) OR - Previously achieved a remission and then progressed or relapsed within 6 months of therapy - At least 1 bidimensionally measurable lesion - Lesions within a previously irradiated field are not considered measurable - No relapse within 6 months after prior autologous bone marrow transplantation - No prior allogeneic bone marrow or stem cell transplantation or post-transplant lymphoproliferative disorder - No parenchymal or meningeal CNS involvement unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic: - Total bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement) - PT, INR, and PTT less than 1.5 times ULN - No chronic hepatitis B or C Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No clinically evident congestive heart failure - No New York Heart Association class III or IV heart disease - No serious cardiac arrhythmias - No active coronary artery disease or ischemia Other: - No prior hypersensitivity to taxane compounds - No known or suspected allergy to the investigational study agent or any agent given in association with this study - No other prior or concurrent malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the bladder or cervix (adequately cone biopsied) - No substance abuse or medical, psychological, or social conditions that would preclude study participation - No active clinically serious infections - No other condition that is unstable or would preclude study participation - No grade 2 or greater pre-existing peripheral neuropathy - No history of seizure disorder - Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - See Chemotherapy - At least 4 weeks since prior anticancer immunotherapy - At least 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF]) - No concurrent anticancer immunotherapy - No concurrent prophylactic G-CSF - Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed - Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months prior to study Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior anticancer chemotherapy - No more than 3 prior systemic chemotherapy regimens for metastatic NHL: - High-dose therapy for autologous hematopoietic stem cell transplantation (SCT) is considered 1 prior regimen - Salvage chemotherapy followed by autologous bone marrow transplant or peripheral SCT is considered 1 prior regimen - Antibody treatment is not considered 1 prior regimen - No prior taxanes or oxaliplatin - No other concurrent anticancer chemotherapy Endocrine therapy: - Patients with prior parenchymal or meningeal CNS involvement: - No concurrent acute or tapered steroid therapy - Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy - Concurrent palliative radiotherapy allowed provided: - No progressive disease - No more than 10% of bone marrow is irradiated - Radiation field does not encompass a target lesion - No other concurrent radiotherapy Surgery: - At least 4 weeks since prior major surgery Other: - At least 4 weeks since prior investigational drugs - No other concurrent investigational therapy or approved anticancer therapy - No concurrent illicit drugs or other substances that would preclude study - Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT - Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints - Concurrent bisphosphonates for prophylaxis or bone metastases allowed
|Official title||An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma|
|Description||OBJECTIVES: - Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma treated with BAY 59-8862. - Determine the overall survival in patients treated with this drug. - Determine the time to progression in patients treated with this drug. - Determine the duration of response (CR and PR) in patients treated with this drug. - Determine the qualitative and quantitative toxicity profile of this drug in this patient population. - Determine the pharmacokinetic profile of this drug in selected patients. OUTLINE: This is a multicenter, open-label study. Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years. PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.|
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