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A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

HIV Infections Clinical Trial

Official title:
A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma

Clinical Trial Summary

To study the safety and maximum tolerated dose (MTD) of combined chemotherapy when it is administered to patients with advanced Kaposi's sarcoma together with one of two different doses of zidovudine (AZT). The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposi's sarcoma. The MTD of combined chemotherapy is being determined so that the information will be available for future studies, when the relative effectiveness of the two doses of AZT has been learned.

Clinical Trial Description

The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposi's sarcoma. The MTD of combined chemotherapy is being determined so that the information will be available for future studies, when the relative effectiveness of the two doses of AZT has been learned. AMENDED: AZT by mouth. If the treatment is well tolerated, subsequent groups of patients are started on increasing doses of doxorubicin combined with the same dose of bleomycin and vincristine. After determination of the MTD of chemotherapy in combination with AZT, the 2nd phase begins in which AZT is given and the first group of patients is given bleomycin and vincristine only. If this combination is well tolerated, then the subsequent groups are started on increasing doses of doxorubicin with the same dose of bleomycin, vincristine and AZT. The MTD of chemotherapy in combination with AZT is then determined. Patients achieving maximum response to the tumor are maintained on AZT alone. This is an outpatient study, and patients are seen every 2 weeks for evaluation, with a physical examination every month. Original design: The combination of chemotherapy and AZT is given to groups of four patients each, the first group beginning with bleomycin and vincristine, without the addition of doxorubicin. The chemotherapy is given intravenously every 2 weeks. This is combined first with AZT by mouth. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00000987
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Completion date April 1992
View Details
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