Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Study Completion Date

2002-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.

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Detailed Description

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OBJECTIVES: I. Determine the objective response rate, response duration and survival of patients receiving bleomycin as salvage therapy for AIDS-related or immunocompetent non-Hodgkin's lymphoma. II. Assess the feasibility and toxicity of treatment for this disease. III. Evaluate the quality of life of AIDS and non-AIDS patients with non-Hodgkin's lymphoma.

OUTLINE: Patients are stratified by number of prior cytotoxic chemotherapy regimens, prior radiotherapy, and HIV/AIDS status. Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve complete remission receive 2 more cycles. Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs. Quality of life assessments are conducted at beginning of therapy, every 3 weeks, and at completion of treatment. Patients are followed every 3 months for overall survival.

PROJECTED ACCRUAL: A total of 32 patients will be accrued.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bleomycin sulfate

Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve complete remission receive 2 more cycles. Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-3 Life expectancy: At least 6 weeks Hematopoietic: WBC at least 1500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Other: May be HIV positive Immunocompetent (HIV-seronegative) NHL patients must be suitable candidates for bleomycin chemotherapy Active infections undergoing drug treatment allowed Negative head CT/MRI scan

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 prior systemic chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy for localized stage I/II disease that has progressed beyond initial radiation therapy port is allowed Surgery: Not specified Other: Concurrent zidovudine, didanosine, or zalcitabine therapy allowed

Eligible Sex

ALL

Accepts Healthy Volunteers

No