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

Completed · Phase 3

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002147

Run by

Sequus Pharmaceuticals

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sequus Pharmaceutical Inc — Menlo Park, California, United States

Full record on ClinicalTrials.gov

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