Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

Concurrent Medication:

Allowed:

• G-CSF.
• Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).
• PCP prophylaxis (required if CD4 count \< 200 cells/mm3).
• Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.
• Up to 14 days of metronidazole.
• Recombinant erythropoietin.

Patients must have:

• Documented HIV infection.
• Advanced stage Kaposi's sarcoma.
• No active acute opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Significant pulmonary insufficiency (unless due to pulmonary KS).
• Significant cardiac insufficiency.
• Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.
• Grade 2 or worse peripheral neuropathy.
• Altered mental status that prevents informed consent.
• Active Mycobacterium tuberculosis.
• Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF).

Concurrent Medication:

Excluded:

• GM-CSF.
• Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine).
• Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair).

Concurrent Treatment:

Excluded:

• Radiation therapy to study marker lesions.

Patients with the following prior condition are excluded:

• Neuropsychiatric history.

Prior Medication:

Excluded:

• Any anti-KS therapy within 21 days prior to study entry.
• Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin.
• Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry.

PER AMENDMENT 11/29/95:

• No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.