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

Sequus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Sarcoma, Kaposi; HIV Infections

Treatments: Drug: Doxorubicin hydrochloride (liposomal)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002147

134D

LTI-30-25

Details and patient eligibility

About

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.

Full description

Patients receive DOX-SL every 3 weeks for up to 20 cycles.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.