Evaluation of Novel Therapeutic Agents Against Breast Cancer: An Innovative Randomized Phase II Trial Design
OBJECTIVES: I. Determine the activity of interleukin-12 as defined by the percentage of
patients who have not progressed after 6 months of therapy. II. Compare percentage of
patients who have not progressed after six months with or without treatment regimen. III.
Determine time to progression and overall survival in this patient population after this
treatment.
OUTLINE: This is a randomized study. Patients are stratified according to disease free
interval from primary diagnosis to first metastases (less than 3 years vs 3 years and
longer), estrogen receptor status (positive vs negative), and disease status (complete
response, partial response, detectable disease, or stable disease). Patients are randomized
to one of two treatment arms. Arm I: Patients begin therapy no sooner than 3 weeks and no
later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12
subcutaneously twice a week. Treatment continues in the absence of disease progression or
unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no
progression after 1 year, may be followed as needed for new signs or symptoms and survival
for 5 years. Arm II: Patients are observed for 6 months. If disease progresses during first
6 months, patients may receive interleukin-12 as in arm I. Patients without disease
progression within first 6 months may also then receive interleukin-12 as in arm I.
Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
are followed for toxicity only until interleukin-12 is discontinued.
PROJECTED ACCRUAL: A total of 92 patients (46 per arm) will be accrued for this study within
8 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Daniel F. Hayes, MD
Study Chair
University of Michigan Cancer Center
United States: Federal Government
CDR0000067570
NCT00004893
December 1999
February 2002
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 Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
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 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
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 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
CCOP - Southwestern Vermont Regional Cancer Center | Bennington, Vermont 05201 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Lombardi Cancer Center, Georgetown University | Washington, District of Columbia 20007 |
North Shore University Hospital | Manhasset, New York 11030 |
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 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
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 |