BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: ortataxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ortataxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent grade 3 follicular lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma