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A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent Non-Hodgkin's Lymphoma
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
July 1, 1997
Primary Completion Date
August 1, 2001
Completion Date
December 1, 2002
Last Updated
June 11, 2010
5
ACTUAL participants
bleomycin sulfate
BIOLOGICAL
Lead Sponsor
Case Comprehensive Cancer Center
Collaborators
NCT06337318
NCT07388563
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