PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Biological: PANVAC™-VF	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Therion Biologics Corporation:

Estimated Enrollment:	250
Study Start Date:	June 2004

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088660

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Locations

United States, Alabama
University of South Alabama/ Cancer Research Institute
Mobile, Alabama, United States, 36693
United States, California
Moores UCSD Cancer Center
LaJolla, California, United States, 92093
Pacific Shores Medical Group
Long Beach, California, United States, 90813
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Chao Family Comprehensice Cancer Center
Orange, California, United States, 92868
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States, 92270
VA San Diego Healthcare System
San Diego, California, United States, 92161
Scripps Cancer Center
San Diego, California, United States, 92121
United States, Colorado
University of Colorado Health Science Center
Aurora, Colorado, United States, 80045
Greeley Medical Clinic
Greeley, Colorado, United States, 80631
Loveland Hematology Oncology
Loveland, Colorado, United States, 80538
United States, Connecticut
Norwalk Hospital/ Whittingham Cancer Center
Norwalk, Connecticut, United States, 06856
United States, District of Columbia
Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
Washington Hospital Cancer Center
Washington, District of Columbia, United States, 20010
United States, Florida
Jupiter Medical Center
Jupiter, Florida, United States, 33458
VA Medical Center
Miami, Florida, United States, 33125
Sylvester Cancer Center
Miami, Florida, United States, 33136
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Idaho
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
North Idaho Cancer Center
Coeur D Alene, Idaho, United States, 83814
United States, Illinois
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
Oncology Associates
Cedar Rapids, Iowa, United States, 52403
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Hematology Oncology Life Center
Alexandria, Louisiana, United States, 71301
Medical Oncology, LLC
Baton Rouge, Louisiana, United States, 70809
Jayne Gurtler, MD and Laura Brinz, MD APMC
Metairie, Louisiana, United States, 70006
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074
United States, Maryland
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Tufts-New England Medical Center, The Neeley Center for Clinical Research
Boston, Massachusetts, United States, 02111
United States, Michigan
Josephine Ford Cancer Center
Detroit, Michigan, United States, 48202
United States, Missouri
Kansas City Cancer Center
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Saint Louis University Cancer Center
St. Louis, Missouri, United States, 63110
United States, Montana
Great Falls Clinic, LLP
Great Falls, Montana, United States, 59405
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
New York Oncology Hematology
Albany, New York, United States, 12208
Winthrop Oncology/Hematology Division
Mineola, New York, United States, 11501
Columbia Presbyterian Medical Center
New York City, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States, 43235
Dayton Oncology Hematology
Kettering, Ohio, United States, 45409
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Temple University Cancer Center
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29403
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Texas Cancer Care
Fort Worth, Texas, United States, 76104
Dr. H. Alejandro Preti, F.A.C.P.
Houston, Texas, United States, 77030
Elkins Pancreas Center
Houston, Texas, United States, 77030
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Cancer Care
Weatherford, Texas, United States, 76086
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23220
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Cancer Care Northwest
Spokane, Washington, United States, 99218
United States, Wisconsin
Medical Consultants Ltd.
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Therion Biologics Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00088660 History of Changes
Other Study ID Numbers:	TBC-PAN-003
Study First Received:	July 30, 2004
Last Updated:	February 7, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Therion Biologics Corporation:

Metastatic

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013