Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Condition: Anaplastic Large Cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Anaplastic; Recurrence
Intervention: ixabepilone
Intervention description: Given IV
Intervention MeSH terms: Epothilones; Epothilone B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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