A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma
Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and
suppression of HIV in some patients. Although various trials using IFN-alpha in combination
with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor
activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia)
of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this
drug may be better tolerated than zidovudine when combined with IFN-alpha.
Up to 90 patients are randomized to receive either low or high doses of IFN-alpha (1 or 10
million Units/day) in combination with a fixed dose of ddI. Fourteen patients are initially
entered at each dose level. If no objective antitumor responses are observed among the first
14 patients at a given dose, no further patients are entered on that treatment arm. If one
or more antitumor responses are seen at a given dose, up to 45 patients may be entered on
that treatment arm. Patients must complete at least 4 weeks of study therapy to be
considered evaluable for tumor response. Treatment is continued until tumor progression or
unacceptable toxicity occurs. PER AMENDMENT 9/19/96: NOTE - After 16 weeks of treatment
subjects may receive any FDA approved antiretroviral drug regimen in addition to or in
place of ddI.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Krown SE
Study Chair
United States: Federal Government
ACTG 206
NCT00001114
March 2000
Name | Location |
---|---|
Stanford CRS | Palo Alto, California 94305 |
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 |
Bmc Actg Crs | Boston, Massachusetts 02118 |
St. Louis ConnectCare, Infectious Diseases Clinic | St Louis, Missouri 63112 |
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 |
Univ. of Cincinnati CRS | Cincinnati, Ohio 45267 |
Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |