A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month. Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. Foscarnet for new episodes of cytomegalovirus infection. Colony-stimulating factors and erythropoietin. Patients must have: Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following: At least 25 mucocutaneous lesions. Ten or more new lesions in the prior month. Documented visceral disease with at least two accessible cutaneous lesions. Two accessible cutaneous lesions with edema. Documented anti-HIV antibody. No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). Life expectancy > 4 months. NOTE: Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinically significant cardiac, hepatic, or renal disease. Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss. Inability to comply with the study. Concurrent Medication: Excluded: Other cytotoxic chemotherapy. Ganciclovir. Patients with the following prior conditions are excluded: Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function. History of idiosyncratic or allergic reaction to bleomycin or vincristine. Prior Medication: Excluded: Prior anthracycline therapy. Cytotoxic chemotherapy or interferon treatment within the past 4 weeks. Prior Treatment: Excluded: Radiation or electron beam therapy within the past 3 weeks.