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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sequus Pharmaceuticals
• Treatments: Doxorubicin; Liposomal doxorubicin

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.