Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma

Inclusion Criteria

Concurrent Medication:

Allowed:

• Ongoing and/or maintenance therapy for opportunistic infection.
• Medications for nausea, vomiting, and diarrhea resulting from drug.

Patients must have AIDS related Kaposi's sarcoma.

• Patients may demonstrate positive blood cultures for Mycobacterium avium-complex or cytomegalovirus.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions will be excluded:

• Patients with active opportunistic infection.
• Patients with concurrent neoplasm other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
• Patients with significant neurologic, cardiac, or liver disease.

Concurrent Medication:

Excluded:

• Antiretroviral agents.
• Immunomodulators.
• Corticosteroids.
• Experimental drugs.

The following patients will be excluded from the study:

• Patients with lymphadenopathy alone and/or visceral disease alone secondary to Kaposi's sarcoma.

Prior Medication:

Excluded:

• Cytotoxic chemotherapy.
• Excluded within 30 days of study entry:
• Antiretroviral agents.
• Biologic modifiers.
• Corticosteroids.

Prior Treatment:

Excluded:

• Total body electron beam therapy.
• Excluded within 30 days of study entry:
• Radiation therapy.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety