Status:
COMPLETED
A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sarcoma, Kaposi
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 o...
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 t...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 1990
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00000996
End Date
June 1 1990
Last Update
November 4 2021
Active Locations (12)
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1
UCLA CARE Ctr
Los Angeles, California, United States, 90095
2
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
3
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States, 20037
4
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013