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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
220
Beth Israel Hosp
Boston, Massachusetts, United States
Mount Sinai Med Ctr
New York, New York, United States
Twelve Oaks Hosp
Houston, Texas, United States
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.