A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of March 19, 2025
Completed
Keywords
ClinConnect Summary
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 respo...
Gender
ALL
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.
Trial Officials
MA Fischl
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
New York, New York, United States
Rochester, New York, United States
Miami, Florida, United States
Boston, Massachusetts, United States
Buffalo, New York, United States
Los Angeles, California, United States
San Francisco, California, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
New York, New York, United States
Washington, District Of Columbia, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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