randomized, comparative trial of dox-sl (stealth liposomal doxorubicin hydrochloride) versus bleomycin and vincristine in the treatment of aids-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

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.

patients are randomized to receive either dox-sl or the bv combination. infusions are given on day 1 and every 3 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 who respond to therapy will be followed every 2 months for up to 1 year. patients must agree to have one or more representative ks lesions biopsied.

Eligibility 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.

Keywords: vincristine sarcoma, kaposi liposomes doxorubicin drug therapy, combination acquired immunodeficiency syndrome bleomycin drug carriers