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

Phase 2

Completed

• Conditions: Sarcoma, Kaposi; HIV Infections

• Registration Number: NCT00000996
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin.

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

Detailed Description

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

Patients are stratified for non-therapy purposes into 2 groups; doxorubicin is given intravenously (IV) every week on an outpatient basis. Patients are monitored carefully, and weekly blood samples are taken to determine the effectiveness and safety of treatment. Patients are evaluated for toxicity after one dose of the drug and weekly thereafter. Patients are evaluated for response to the drug after 4 weeks and monthly thereafter.

Study Timeline

• Study Completion: 1990-06
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (12)

UCLA CARE Ctr; 🇺🇸 Los Angeles, California, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

George Washington Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Univ of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Charity Hosp / Tulane Univ Med School; 🇺🇸 New Orleans, Louisiana, United States

Tulane Univ School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Beth Israel Deaconess - West Campus; 🇺🇸 Boston, Massachusetts, United States

SUNY / Erie County Med Ctr at Buffalo; 🇺🇸 Buffalo, New York, United States

Bellevue Hosp / New York Univ Med Ctr; 🇺🇸 New York, New York, United States

Mem Sloan - Kettering Cancer Ctr; 🇺🇸 New York, New York, United States

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