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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000996 |
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.
Condition | Intervention | Phase |
Sarcoma, Kaposi HIV Infections |
Drug: Doxorubicin hydrochloride |
Phase II |
MedlinePlus related topics: | AIDS Kaposi's Sarcoma Soft Tissue Sarcoma |
Drug Information available for: | Doxorubicin Doxorubicin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma |
Estimated Enrollment: | 48 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have AIDS related Kaposi's sarcoma.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
Concurrent Medication:
Excluded:
The following patients will be excluded from the study:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, California | |||||
San Francisco AIDS Clinic / San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
UCLA CARE Ctr | |||||
Los Angeles, California, United States, 90095 | |||||
United States, District of Columbia | |||||
George Washington Univ Med Ctr | |||||
Washington, District of Columbia, United States, 20037 | |||||
United States, Florida | |||||
Univ of Miami School of Medicine | |||||
Miami, Florida, United States, 331361013 | |||||
United States, Louisiana | |||||
Charity Hosp / Tulane Univ Med School | |||||
New Orleans, Louisiana, United States, 70112 | |||||
Tulane Univ School of Medicine | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess - West Campus | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, New York | |||||
Univ of Rochester Medical Center | |||||
Rochester, New York, United States, 14642 | |||||
Mem Sloan - Kettering Cancer Ctr | |||||
New York, New York, United States, 10021 | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
SUNY / Erie County Med Ctr at Buffalo | |||||
Buffalo, New York, United States, 14215 | |||||
United States, Ohio | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 |
Study Chair: | MA Fischl |
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)
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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. 1993 Mar;6(3):259-64.
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Study ID Numbers: | ACTG 006 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000996 |
Health Authority: | United States: Federal Government |
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