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

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