A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.
Continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve CR receive 2 more cycles. Patients with PR or stable disease may continue therapy until disease progression or unacceptable toxicity occurs.
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|