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

Inclusion Criteria

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.