A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma

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

To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin.

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

Patients are stratified for non-therapy purposes into 2 groups; doxorubicin is given intravenously (IV) every week on an outpatient basis. Patients are monitored carefully, and weekly blood samples are taken to determine the effectiveness and safety of treatment. Patients are evaluated for toxicity after one dose of the drug and weekly thereafter. Patients are evaluated for response to the drug after 4 weeks and monthly thereafter.

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.