Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Epothilone B; Epothilones

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