PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
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
1 other identifier
interventional
250
1 country
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pancreatic-cancer
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 30, 2004
CompletedFirst Posted
Study publicly available on registry
August 2, 2004
CompletedFebruary 8, 2006
February 1, 2006
July 30, 2004
February 7, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
University of South Alabama/ Cancer Research Institute
Mobile, Alabama, 36693, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Chao Family Comprehensice Cancer Center
Orange, California, 92868, United States
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, 92270, United States
Scripps Cancer Center
San Diego, California, 92121, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
University of Colorado Health Science Center
Aurora, Colorado, 80045, United States
Greeley Medical Clinic
Greeley, Colorado, 80631, United States
Loveland Hematology Oncology
Loveland, Colorado, 80538, United States
Norwalk Hospital/ Whittingham Cancer Center
Norwalk, Connecticut, 06856, United States
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Washington Hospital Cancer Center
Washington D.C., District of Columbia, 20010, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
VA Medical Center
Miami, Florida, 33125, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Sylvester Cancer Center
Miami, Florida, 33136, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Oncology Associates
Cedar Rapids, Iowa, 52403, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Hematology Oncology Life Center
Alexandria, Louisiana, 71301, United States
Medical Oncology, LLC
Baton Rouge, Louisiana, 70809, United States
Jayne Gurtler, MD and Laura Brinz, MD APMC
Metairie, Louisiana, 70006, United States
Tulane Cancer Center
New Orleans, Louisiana, 70112, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074, United States
Franklin Square Hospital
Baltimore, Maryland, 21237, United States
Tufts-New England Medical Center, The Neeley Center for Clinical Research
Boston, Massachusetts, 02111, United States
Josephine Ford Cancer Center
Detroit, Michigan, 48202, United States
Kansas City Cancer Center
Kansas City, Missouri, 64111, United States
Saint Louis University Cancer Center
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Great Falls Clinic, LLP
Great Falls, Montana, 59405, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
New York Oncology Hematology
Albany, New York, 12208, United States
Winthrop Oncology/Hematology Division
Mineola, New York, 11501, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235, United States
Dayton Oncology Hematology
Kettering, Ohio, 45409, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Temple University Cancer Center
Philadelphia, Pennsylvania, 19140, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29403, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Texas Cancer Care
Fort Worth, Texas, 76104, United States
Dr. H. Alejandro Preti, F.A.C.P.
Houston, Texas, 77030, United States
Elkins Pancreas Center
Houston, Texas, 77030, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Texas Cancer Care
Weatherford, Texas, 76086, United States
Virginia Cancer Institute
Richmond, Virginia, 23220, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Cancer Care Northwest
Spokane, Washington, 99218, United States
Medical Consultants Ltd.
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 30, 2004
First Posted
August 2, 2004
Study Start
June 1, 2004
Last Updated
February 8, 2006
Record last verified: 2006-02