Non Hodgkin Lymphoma Clinical Trial
Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin’s Lymphoma
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.
Full Description
OBJECTIVES:
I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).
II. Determine the safety and toxicity of this drug in these patients. III. Determine the duration of response, overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multi-center study.
Patients receive ixabepilone intravenously (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.
Patients are followed every 8 weeks until disease progression.
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
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There are 2 Locations for this study
Chicago Illinois, 60637, United States
Houston Texas, 77030, United States
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