HIV Infections, Sarcoma, Kaposi
Conditions
Keywords
Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers
Brief summary
To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.
Detailed description
Patients receive DOX-SL every 3 weeks for up to 20 cycles.
Interventions
Sponsors
Sequus Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * AIDS-related Kaposi's sarcoma that requires systemic chemotherapy. * EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL. Prior Medication: Allowed: * Prior anthracyclines.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Cardiac ejection fraction \< 50 percent or clinically significant cardiac disease. * Eligibility for a Liposomal Technology comparative protocol. Concurrent Medication: Excluded: * Other cytotoxic chemotherapy. Patients with the following prior condition are excluded: History of idiosyncratic or allergic reaction to anthracyclines. Prior Medication: Excluded: * Chemotherapy within the past 3 weeks.
Countries
United States
Outcome results
None listed