A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVAC™-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic (Stage IV) Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen
PANVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the
body can be taught to fight cancer by directing the immune system to attack specific targets
found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This
trial will help determine if this vaccine can help fight cancer.
All patients will be required to sign an informed consent prior to the performance of any
study-related procedures. Patients will be screened for eligibility within 14 days prior to
their anticipated treatment start date (Day 0). Patients who meet all inclusion and
exclusion criteria will be centrally randomized into the study and will receive a unique
patient identification number and a treatment assignment. The ratio of active treatment to
control is 1:1 (PANVAC-VF: best supportive care or palliative chemotherapy).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
TBC-PAN-003
NCT00088660
June 2004
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Temple University Cancer Center | Philadelphia, Pennsylvania 19140 |
Swedish Cancer Institute | Seattle, Washington 98104 |
North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
Arlington Cancer Center | Arlington, Texas 76012 |
Jackson Memorial Hospital | Miami, Florida 33136 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Carle Cancer Center | Urbana, Illinois 61801 |
Tulane Cancer Center | New Orleans, Louisiana 70112 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Texas Cancer Care | Fort Worth, Texas 76104 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
Tyler Cancer Center | Tyler, Texas 75702 |
Medical Oncology, LLC | Baton Rouge, Louisiana 70808 |
Cancer Care Northwest | Spokane, Washington 99202 |
Duke University Medical Center | Durham, North Carolina 27710 |
Scripps Cancer Center | La Jolla, California 92037 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
University of Colorado Health Science Center | Aurora, Colorado 80010-0510 |
Charleston Cancer Center | Charleston, South Carolina 29406 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
The Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
Columbia Presbyterian Medical Center | New York, New York 10032 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Charleston Hematology Oncology | Charleston, South Carolina 29403 |
Hematology Oncology Consultants, Inc. | Columbus, Ohio 43235 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Oncology Associates | Cedar Rapids, Iowa 52403 |
Josephine Ford Cancer Center | Detroit, Michigan 48202 |
The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Kansas City Cancer Center | Kansas City, Missouri 64111 |
New York Oncology Hematology | Albany, New York 12208 |
VA Medical Center | Miami, Florida 33125 |
Dayton Oncology Hematology | Kettering, Ohio 45067 |
VA San Diego Healthcare System | San Diego, California 92161 |
University of South Alabama/ Cancer Research Institute | Mobile, Alabama 36693 |
Chao Family Comprehensice Cancer Center | Orange, California 92868 |
Desert Hematology Oncology Medical Group, Inc | Rancho Mirage, California 92270 |
Greeley Medical Clinic | Greeley, Colorado 80631 |
Loveland Hematology Oncology | Loveland, Colorado 80538 |
Norwalk Hospital/ Whittingham Cancer Center | Norwalk, Connecticut 06856 |
Lombardi Comprehensive Cancer Center | Washington, District of Columbia 20007 |
Washington Hospital Cancer Center | Washington, District of Columbia 20010 |
Jupiter Medical Center | Jupiter, Florida 33458 |
Sylvester Cancer Center | Miami, Florida 33136 |
St. Luke's Mountain States Tumor Institute | Boise, Idaho 83712 |
Hematology Oncology Life Center | Alexandria, Louisiana 71301 |
Jayne Gurtler, MD and Laura Brinz, MD APMC | Metairie, Louisiana 70006 |
Franklin Square Hospital | Baltimore, Maryland 21237 |
Tufts-New England Medical Center, The Neeley Center for Clinical Research | Boston, Massachusetts 02111 |
Great Falls Clinic, LLP | Great Falls, Montana 59405 |
Winthrop Oncology/Hematology Division | Mineola, New York 11501 |
University of Oklahoma Health Science Center | Oklahoma City, Oklahoma 73104 |
Dr. H. Alejandro Preti, F.A.C.P. | Houston, Texas 77030 |
Elkins Pancreas Center | Houston, Texas 77030 |
Medical Consultants Ltd. | Milwaukee, Wisconsin 53215 |