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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
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East Bay AIDS Ctr
Berkeley, California, United States
Pacific Oaks Med Group
Beverly Hills, California, United States
Hematology - Oncology Med Group of San Fernando Valley
Encino, California, United States
Dr Becky Miller
Los Angeles, California, United States
Apogee Med Group
San Diego, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
UCSF
San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States
UCSF
San Francisco, California, United States
...and 23 more locations