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.