NCT00000996

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

Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma, Kaposi
• HIV Infections

Interventions

Type	Name	Description
DRUG	Doxorubicin hydrochloride

Timeline

• Completion: 1990-06-01
• First posted: 2001-08-31
• Last updated: 2021-11-04

Locations

12 sites across 1 country: United States