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Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.



Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Sequus Pharmaceuticals ,
Synopsis: 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.
Details: Patients receive DOX-SL every 3 weeks for up to 20 cycles.
Eligibility:
Study Type:  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 

Location and Contact Information:

Sequus Pharmaceutical Inc
Menlo Park,  California,  94025
United States
 


Additional Information:
Study ID Numbers:  134D;  LTI-30-25
Study Start Date: 
Record last reviewed: January 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002147

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