Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma

Inclusion Criteria

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.