PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
NCT ID: NCT00088660
Last Updated: 2006-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
250 participants
INTERVENTIONAL
2004-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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PANVAC™-VF
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Therion Biologics Corporation
INDUSTRY
Locations
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University of South Alabama/ Cancer Research Institute
Mobile, Alabama, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Chao Family Comprehensice Cancer Center
Orange, California, United States
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States
Scripps Cancer Center
San Diego, California, United States
VA San Diego Healthcare System
San Diego, California, United States
University of Colorado Health Science Center
Aurora, Colorado, United States
Greeley Medical Clinic
Greeley, Colorado, United States
Loveland Hematology Oncology
Loveland, Colorado, United States
Norwalk Hospital/ Whittingham Cancer Center
Norwalk, Connecticut, United States
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Washington Hospital Cancer Center
Washington D.C., District of Columbia, United States
Jupiter Medical Center
Jupiter, Florida, United States
VA Medical Center
Miami, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Sylvester Cancer Center
Miami, Florida, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Carle Cancer Center
Urbana, Illinois, United States
Oncology Associates
Cedar Rapids, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Hematology Oncology Life Center
Alexandria, Louisiana, United States
Medical Oncology, LLC
Baton Rouge, Louisiana, United States
Jayne Gurtler, MD and Laura Brinz, MD APMC
Metairie, Louisiana, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Franklin Square Hospital
Baltimore, Maryland, United States
Tufts-New England Medical Center, The Neeley Center for Clinical Research
Boston, Massachusetts, 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
Washington University School of Medicine
St Louis, Missouri, United States
Great Falls Clinic, LLP
Great Falls, Montana, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York Oncology Hematology
Albany, New York, United States
Winthrop Oncology/Hematology Division
Mineola, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States
Dayton Oncology Hematology
Kettering, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Temple University Cancer Center
Philadelphia, Pennsylvania, United States
Charleston Hematology Oncology
Charleston, South Carolina, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Texas Cancer Care
Fort Worth, Texas, United States
Dr. H. Alejandro Preti, F.A.C.P.
Houston, Texas, United States
Elkins Pancreas Center
Houston, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Cancer Care
Weatherford, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Medical Consultants Ltd.
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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TBC-PAN-003
Identifier Type: -
Identifier Source: org_study_id