Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by
chemotherapy, allowing more timely administration of chemotherapy and improved response.
Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with
Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is
administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16
through 28 of each cycle. All patients receive four cycles of treatment and are then
restaged. Patients with a complete response (CR) following the initial four cycles receive
two additional cycles of ABVD / G-CSF. Patients with a partial response following the
initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged;
those who have achieved a CR at that point then receive two more cycles, while those without
CR discontinue study therapy. Patients with disease progression following the initial four
cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is
administered.
Interventional
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Levine A
Study Chair
Unspecified
ACTG 149
NCT00000626
February 1999
Name | Location |
---|---|
Alabama Therapeutics CRS | Birmingham, Alabama 35294 |
USC CRS | Los Angeles, California 90033 |
Northwestern University CRS | Chicago, Illinois 60611 |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis, Indiana 46202 |
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 |
The Ohio State Univ. AIDS CRS | Columbus, Ohio 43210 |