A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease
OBJECTIVES:
- Compare progression-free and overall survival of patients with stage III or IV
Hodgkin's disease treated with doxorubicin, bleomycin, vinblastine, and dacarbazine
with or without autologous peripheral blood stem cell transplantation and high-dose
chemotherapy.
- Compare the toxic effects of these treatment regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV).
Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes,
bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30
minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of
disease progression or unacceptable toxicity. Patients who show at least partial response
after the fifth course of induction chemotherapy and whose blood counts have recovered are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8
courses.
- Arm II: Patients receive 1 additional course of induction chemotherapy followed by stem
cell collection. Patients then receive high-dose chemotherapy with carmustine IV over 2
hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on
day -2. Patients undergo autologous peripheral blood stem cell transplantation on day
0.
Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and
then annually thereafter.
PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
No
Ellen R. Gaynor, MD
Study Chair
Loyola University
United States: Federal Government
CDR0000067708
NCT00005090
April 2000
May 2005
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Schneider Children's Hospital at North Shore | Manhasset, New York 11030 |