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

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000996

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Expected to finish

1990-06-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Ongoing and/or maintenance therapy for opportunistic infection.
• Medications for nausea, vomiting, and diarrhea resulting from drug.
• Patients must have AIDS related Kaposi's sarcoma.
• Patients may demonstrate positive blood cultures for Mycobacterium avium-complex or cytomegalovirus.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions will be excluded:
• Patients with active opportunistic infection.
• Patients with concurrent neoplasm other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
• Patients with significant neurologic, cardiac, or liver disease.
• Concurrent Medication:
• Excluded:
• Antiretroviral agents.
• Immunomodulators.
• Corticosteroids.
• Experimental drugs.
• The following patients will be excluded from the study:
• Patients with lymphadenopathy alone and/or visceral disease alone secondary to Kaposi's sarcoma.
• Prior Medication:
• Excluded:
• Cytotoxic chemotherapy.
• Excluded within 30 days of study entry:
• Antiretroviral agents.
• Biologic modifiers.
• Corticosteroids.
• Prior Treatment:
• Excluded:
• Total body electron beam therapy.
• Excluded within 30 days of study entry:
• Radiation therapy.

Where it is running

• 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 D.C., 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
• Univ of Rochester Medical Center — Rochester, New York, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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