HIV Infections, Sarcoma, Kaposi
Conditions
Keywords
Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers
Brief summary
To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.
Detailed description
Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.
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
Concurrent Medication: Allowed: * Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy 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 infections except with potentially myelotoxic chemotherapy. * Foscarnet or ganciclovir for CMV infection. * Colony stimulating factors and erythropoietin. Patients must have: * Moderate to severe AIDS-related Kaposi's sarcoma. * Documented anti-HIV antibody. * No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). NOTE: * Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Clinically significant cardiac disease. * Confusion or disorientation. Concurrent Medication: Excluded: * Other cytotoxic cancer chemotherapy. Patients with the following prior conditions are excluded: * Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function. * History of idiosyncratic or allergic reaction to anthracyclines. * History of major psychiatric illness. Prior Medication: Excluded within the past 4 weeks: * Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol). * Interferon treatment. Prior Treatment: Excluded within the past 3 weeks: * Radiation or electron beam therapy.
Countries
United States
Outcome results
None listed