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Clinical Trials/NCT00000987
NCT00000987
Completed
Phase 1

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

National Institute of Allergy and Infectious Diseases (NIAID)1 site in 1 country36 target enrollmentAugust 31, 2001

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Sarcoma, Kaposi
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment
36
Locations
1
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 31, 2001
End Date
April 1992
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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