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

Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month.
* Maintenance therapy for tuberculosis, fungal, and herpes infections.
* Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
* Foscarnet or ganciclovir for CMV infection.
* Colony stimulating factors and erythropoietin.

Patients must have:

* Moderate to severe AIDS-related Kaposi's sarcoma.
* Documented anti-HIV antibody.
* No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).

NOTE:

* Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant cardiac disease.
* Confusion or disorientation.

Concurrent Medication:

Excluded:

* Other cytotoxic cancer chemotherapy.

Patients with the following prior conditions are excluded:

* Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
* History of idiosyncratic or allergic reaction to anthracyclines.
* History of major psychiatric illness.

Prior Medication:

Excluded within the past 4 weeks:

* Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
* Interferon treatment.

Prior Treatment:

Excluded within the past 3 weeks:

* Radiation or electron beam therapy.