Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine 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 determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.

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

Details

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) 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 infection except with potentially myelotoxic chemotherapy.

• Foscarnet for cytomegalovirus infection.

• Erythropoietin.

Patients must have:

• Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:

• At least 15 mucocutaneous lesions.

• Six or more new lesions in the prior month.

• Documented visceral disease with at least five accessible cutaneous lesions.

• Documented anti-HIV antibody.

• No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING treatment with myelotoxic drugs).

• Life expectancy > 4 months.

NOTE:

• Patients who fail the BV combination or who relapse are eligible to enter the Liposome Technology open trial using DOX-SL alone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Clinically significant cardiac disease.

• Confusion, disorientation, CNS symptoms, or peripheral neuropathy.

Concurrent Medication:

Excluded:

• Other cytotoxic chemotherapy.

• Colony-stimulating factors.

• Ganciclovir.

Patients with the following prior conditions are excluded:

• Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.

• History of idiosyncratic or allergic reaction to anthracyclines, bleomycin, or vincristine.

• History of major psychiatric illness.

Prior Medication:

Excluded:

• Cytotoxic chemotherapy or interferon therapy within the past 4 weeks.

• More than one prior cycle of bleomycin/vincristine at any time.

Prior Treatment:

Excluded:

• Radiation or electron beam therapy within the past 3 weeks.