Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma

Inclusion Criteria

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.