A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
NCT ID: NCT00000996
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
1990-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Doxorubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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MA Fischl
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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Walker RE, et al. The safety, pharmacokinetics, and antiviral activity of N-acetylcysteine in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo8 (abstract no MoB 0022)
Fischl MA, Krown SE, O'Boyle KP, Mitsuyasu R, Miles S, Wernz JC, Volberding PA, Kahn J, Groopman JE, Feinberg J, et al. Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group. J Acquir Immune Defic Syndr (1988). 1993 Mar;6(3):259-64.
Other Identifiers
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10982
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 006
Identifier Type: -
Identifier Source: org_study_id