A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

Phase 3

Completed

• Conditions: Sarcoma, Kaposi; HIV Infections

• Registration Number: NCT00002319
• Lead Sponsor: Sequus Pharmaceuticals

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 1996-01
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (31)

East Bay AIDS Ctr; 🇺🇸 Berkeley, California, United States

Pacific Oaks Med Group; 🇺🇸 Sherman Oaks, 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

Dr Mahmoud Mustafa; 🇺🇸 Washington, District of Columbia, United States

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