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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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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

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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).

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PANVAC™-VF

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Therion Biologics Corporation

INDUSTRY

Sponsor Role lead

Locations

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University of South Alabama/ Cancer Research Institute

Mobile, Alabama, United States

Site Status

Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Pacific Shores Medical Group

Long Beach, California, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Chao Family Comprehensice Cancer Center

Orange, California, United States

Site Status

Desert Hematology Oncology Medical Group, Inc

Rancho Mirage, California, United States

Site Status

Scripps Cancer Center

San Diego, California, United States

Site Status

VA San Diego Healthcare System

San Diego, California, United States

Site Status

University of Colorado Health Science Center

Aurora, Colorado, United States

Site Status

Greeley Medical Clinic

Greeley, Colorado, United States

Site Status

Loveland Hematology Oncology

Loveland, Colorado, United States

Site Status

Norwalk Hospital/ Whittingham Cancer Center

Norwalk, Connecticut, United States

Site Status

Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Washington Hospital Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Jupiter Medical Center

Jupiter, Florida, United States

Site Status

VA Medical Center

Miami, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Sylvester Cancer Center

Miami, Florida, United States

Site Status

St. Luke's Mountain States Tumor Institute

Boise, Idaho, United States

Site Status

North Idaho Cancer Center

Coeur d'Alene, Idaho, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Hematology Oncology Life Center

Alexandria, Louisiana, United States

Site Status

Medical Oncology, LLC

Baton Rouge, Louisiana, United States

Site Status

Jayne Gurtler, MD and Laura Brinz, MD APMC

Metairie, Louisiana, United States

Site Status

Tulane Cancer Center

New Orleans, Louisiana, United States

Site Status

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, United States

Site Status

Franklin Square Hospital

Baltimore, Maryland, United States

Site Status

Tufts-New England Medical Center, The Neeley Center for Clinical Research

Boston, Massachusetts, United States

Site Status

Josephine Ford Cancer Center

Detroit, Michigan, United States

Site Status

Kansas City Cancer Center

Kansas City, Missouri, United States

Site Status

Saint Louis University Cancer Center

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Great Falls Clinic, LLP

Great Falls, Montana, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

New York Oncology Hematology

Albany, New York, United States

Site Status

Winthrop Oncology/Hematology Division

Mineola, New York, United States

Site Status

Columbia Presbyterian Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Gabrail Cancer Center

Canton, Ohio, United States

Site Status

Hematology Oncology Consultants, Inc.

Columbus, Ohio, United States

Site Status

Dayton Oncology Hematology

Kettering, Ohio, United States

Site Status

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Site Status

Temple University Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Charleston Hematology Oncology

Charleston, South Carolina, United States

Site Status

Charleston Cancer Center

Charleston, South Carolina, United States

Site Status

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Site Status

The Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

Arlington Cancer Center

Arlington, Texas, United States

Site Status

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Texas Cancer Care

Fort Worth, Texas, United States

Site Status

Dr. H. Alejandro Preti, F.A.C.P.

Houston, Texas, United States

Site Status

Elkins Pancreas Center

Houston, Texas, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

Texas Cancer Care

Weatherford, Texas, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Cancer Care Northwest

Spokane, Washington, United States

Site Status

Medical Consultants Ltd.

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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TBC-PAN-003

Identifier Type: -

Identifier Source: org_study_id