Phase I/II Study of Combination Chemotherapy (Adriamycin, Bleomycin, +/- Vincristine) and Dideoxyinosine (ddI) or Dideoxycytidine (ddC) in the Treatment of AIDS-Related Kaposi's Sarcoma
AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic
agents to reduce the tumor burden, and they also require treatment with other possibly
effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of
opportunistic infections.
In Phase I, eligible patients with advanced Kaposi's sarcoma are randomly assigned to either
ddI or ddC in combination with DBV chemotherapy. On the average, patients receive 12-44
weeks of combined chemotherapy and antiretroviral therapy. If vincristine is deleted from
Phase I because of excess neurotoxicity, it will not be administered as part of the
combination chemotherapy if that treatment is continued in the Phase II study. The Phase II
trial proceeds when at least six cycles (12 weeks) of DBV have been completed by six
patients enrolled in Phase I, and an overall evaluation of tolerance to each combination
treatment plan has been completed. Study medication is administered as in Phase I, with the
possible deletion of vincristine. All patients who complete DBV chemotherapy with complete
or partial response or stable disease will continue to receive the originally assigned
investigational antiretroviral drug (ddC or ddI) for an additional 24 weeks.
Interventional
Primary Purpose: Treatment
Mitsuyasu RT
Study Chair
Unspecified
ACTG 163
NCT00000954
September 1996
Name | Location |
---|---|
UCLA CARE Center CRS | Los Angeles, California 90095 |
USC CRS | Los Angeles, California 90033 |
Ucsf Aids Crs | San Francisco, California |
University of Colorado Hospital CRS | Aurora, Colorado 80262 |
Northwestern University CRS | Chicago, Illinois 60611 |
Rush Univ. Med. Ctr. ACTG CRS | Chicago, Illinois 60612 |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis, Indiana 46202 |
Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
Bmc Actg Crs | Boston, Massachusetts 02118 |
Washington U CRS | St. Louis, Missouri |
SUNY - Buffalo, Erie County Medical Ctr. | Buffalo, New York 14215 |
Memorial Sloan-Kettering Cancer Ctr. | New York, New York 10021 |
Unc Aids Crs | Chapel Hill, North Carolina 27599 |
The Ohio State Univ. AIDS CRS | Columbus, Ohio 43210 |