This trial is active, not recruiting.

Conditions sarcoma, kaposi, hiv infections
Treatments doxorubicin hydrochloride (liposomal), bleomycin sulfate, vincristine sulfate, doxorubicin hydrochloride
Phase phase 3
Sponsor Sequus Pharmaceuticals
Trial size 225 participants
Trial identifier NCT00002318, 134A, LTI-30-10


To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model parallel assignment
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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. - Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. - Foscarnet for new episodes of cytomegalovirus infection. - Colony-stimulating factors and erythropoietin. Patients must have: - Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following: - At least 25 mucocutaneous lesions. - Ten or more new lesions in the prior month. - Documented visceral disease with at least two accessible cutaneous lesions. - Two accessible cutaneous lesions with edema. - Documented anti-HIV antibody. - No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). - Life expectancy > 4 months. NOTE: - Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, 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, hepatic, or renal disease. - Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss. - Inability to comply with the study. Concurrent Medication: Excluded: - Other cytotoxic chemotherapy. - 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 bleomycin or vincristine. Prior Medication: Excluded: - Prior anthracycline therapy. - Cytotoxic chemotherapy or interferon treatment within the past 4 weeks. Prior Treatment: Excluded: - Radiation or electron beam therapy within the past 3 weeks.

Additional Information

Official title Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
Description Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.