A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
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ClinicalTrials.gov Identifier: NCT00002318
Recruitment Status : Unknown
Verified January 1996 by NIH AIDS Clinical Trials Information Service. Recruitment status was: Active, not recruiting
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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.
Other cytotoxic chemotherapy.
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 anthracycline therapy.
Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.
Radiation or electron beam therapy within the past 3 weeks.