Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types: Grade III follicular center Diffuse large B-cell Mantle cell Primary mediastinal B-cell Burkitt's High-grade B-cell (Burkitt-like) Anaplastic large cell of 1 of the following subtypes: CD30-positive T-cell Null cell Hodgkin's-like Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1of the following cohorts: Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy No progressive disease after the most recent prior therapy Measurable disease At least 1 bidimensionally measurable lesion at least 10 mm by conventional techniques or clinical exam Ineligible for or unwilling to undergo hematopoietic stem cell transplantation Patients requiring debulking prior to transplant allowed No known CNS involvement by lymphoma Prior CNS disease that has been successfully treated in patients with relapsed disease exclusively outside of the CNS may be allowed by the principal investigator Performance status - ECOG 0-2 More than 3 months WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,200/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction or hypersensitivity to compounds containing Cremophor EL or agents of similar chemical or biological composition to BMS-247550 No peripheral neuropathy grade 2 or greater No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (previously treated malignancy allowed if considered to be at less than 30% risk of relapse) No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness No colony-stimulating factors (CSFs) within 24 hours of study chemotherapy No CSFs during first course of study therapy No concurrent filgrastim-SD/01 No concurrent immunotherapy See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy No concurrent hormonal therapy At least 4 weeks since prior radiotherapy No concurrent therapeutic radiotherapy At least 4 weeks since prior surgery Recovered from prior therapy At least 7 days since prior cimetidine No concurrent cimetidine No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer medications No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum
Sites / Locations
- University of Chicago
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy)
Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.