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

Sequus Pharmaceuticals

Overview

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.

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Sarcoma, Kaposi HIV Infections

Interventions

Doxorubicin hydrochloride (liposomal)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sequus Pharmaceutical Inc

Menlo Park, California, United States

Data from ClinicalTrials.gov

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