PANVACâ„¢-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00088660
- Lead Sponsor
- Therion Biologics Corporation
- Brief Summary
The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- Patients > 18 years of age who have been vaccinated against smallpox;
- Histologically confirmed diagnosis of adenocarcinoma of the pancreas;
- Patient has metastatic (Stage IV) disease;
- ECOG performance status 0-1;
- Failed a gemcitabine-containing chemotherapeutic regimen within 3 months of study entry.
- Prior or concurrent immunotherapy for cancer;
- Radiation therapy within 28 days prior to registration;
- Systemic corticosteroid therapy (except inhaled or topical steroids) within 28 days of registration;
- Significant cardiovascular abnormalities or diseases;
- Known positive for HIV, hepatitis B and/or C;
- Evidence of immunodeficiency or immune suppression.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Dayton Oncology Hematology
🇺🇸Kettering, Ohio, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Temple University Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Tufts-New England Medical Center, The Neeley Center for Clinical Research
🇺🇸Boston, Massachusetts, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Sylvester Cancer Center
🇺🇸Miami, Florida, United States
VA Medical Center
🇺🇸Miami, Florida, United States
Greeley Medical Clinic
🇺🇸Greeley, Colorado, United States
Columbia Presbyterian Medical Center
🇺🇸New York City, New York, United States
University of South Alabama/ Cancer Research Institute
🇺🇸Mobile, Alabama, United States
Norwalk Hospital/ Whittingham Cancer Center
🇺🇸Norwalk, Connecticut, United States
Great Falls Clinic, LLP
🇺🇸Great Falls, Montana, United States
Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Winthrop Oncology/Hematology Division
🇺🇸Mineola, New York, United States
Moores UCSD Cancer Center
🇺🇸LaJolla, California, United States
Washington Hospital Cancer Center
🇺🇸Washington, District of Columbia, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Loveland Hematology Oncology
🇺🇸Loveland, Colorado, United States
Desert Hematology Oncology Medical Group, Inc
🇺🇸Rancho Mirage, California, United States
University of Colorado Health Science Center
🇺🇸Aurora, Colorado, United States
St. Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Hematology Oncology Consultants, Inc.
🇺🇸Columbus, Ohio, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Dr. H. Alejandro Preti, F.A.C.P.
🇺🇸Houston, Texas, United States
Elkins Pancreas Center
🇺🇸Houston, Texas, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Medical Consultants Ltd.
🇺🇸Milwaukee, Wisconsin, United States
The Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Texas Cancer Care
🇺🇸Weatherford, Texas, United States
New York Oncology Hematology
🇺🇸Albany, New York, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Scripps Cancer Center
🇺🇸San Diego, California, United States
Chao Family Comprehensice Cancer Center
🇺🇸Orange, California, United States
Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
North Idaho Cancer Center
🇺🇸Coeur D Alene, Idaho, United States
Jayne Gurtler, MD and Laura Brinz, MD APMC
🇺🇸Metairie, Louisiana, United States
Hematology Oncology Life Center
🇺🇸Alexandria, Louisiana, United States
Medical Oncology, LLC
🇺🇸Baton Rouge, Louisiana, United States
Tulane Cancer Center
🇺🇸New Orleans, Louisiana, United States
Franklin Square Hospital
🇺🇸Baltimore, Maryland, United States
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
Josephine Ford Cancer Center
🇺🇸Detroit, Michigan, United States
Kansas City Cancer Center
🇺🇸Kansas City, Missouri, United States
Saint Louis University Cancer Center
🇺🇸St. Louis, Missouri, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States