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

February 7, 2006 updated by: Therion Biologics Corporation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Therion Biologics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Registration Dates

First Submitted

July 30, 2004

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Estimate)

February 8, 2006

Last Update Submitted That Met QC Criteria

February 7, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBC-PAN-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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