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Home > "A" Clinical Trials Conditions > A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma  A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 48
Location and Contact Information:
Overall Study Official:
MAFischl, Study Chair,
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Additional Information:
Study ID Numbers: ACTG 006;
Study Start Date:
Record last reviewed: July 1988
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000996
Other Sarcoma, Kaposi Studies:
1. Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS
2. A Study of Tecogalan Sodium
3. Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
4. Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
5. A Phase I Trial of Tecogalan sodium (DS-4152) Administered as an Infusion Every 21 Days
Related Studies:
Other Sarcoma, Kaposi Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
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