ClinicalTrials.Gov Identifier:  NCT00300950

This study is currently enrolling patients.

Summary

GI-4000-02 will evaluate the safety and efficacy of the Tarmogen GI-4000 versus placebo in combination with gemcitabine for the treatment of non-metastatic, post-resection pancreas cancer.

Overview

Pancreas tumors commonly have mutations at codons 12 and 61 of the ras  oncogene.  GI-4000 is designed to enable the immune system to eliminate diseased cells containing the gene product from the seven most common mutations in the ras  oncogene.  Surgical specimens from non-metastatic pancreas cancer patients will undergo genomic DNA sequencing to identify mutation(s) contained in a version of GI-4000.   If the patient is eligible, the appropriate GI-4000 Tarmogen or placebo will be injected under the skin (subcutaneous injection).  Patients will receive three, single weekly subcutaneous injections after surgery, but before initiation of gemcitabine therapy.  Patients will also receive single monthly subcutaneous injections between rounds of gemcitabine.  Patients will be given up to 6 cycles of gemcitabine therapy.  After completion of gemcitabine therapy, patients will be eligible to continue receiving monthly injections of study therapy.  Patients will be monitored for disease recurrence as well as safety, and immune responses related to the injections.

Official Title:

A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces cerevisiae Expressing Mutant Ras Protein Combined with a Gemcitabine Regimen Versus a Gemcitabine Regimen with Placebo, in Patients with Post-resection R0/R1 Pancreatic Cancer with Tumor Sequence Confirmation of Ras Mutations.

Study Details:

Eligibility

Inclusion Criteria:

• Non-metestatic, resectable pancreas cancer
• Tumor must contain a ras mutation at codon 12 or 61 which is matches  one of the GI-4000 products
• Resection must be R0/R1
• >18 years of age, negative skin test for hypersensitivity to saccharomyces cerevisiae. 
• ECOG Performance Score 0 or 1 prior to surgery; or <= ECOG 2 post surgery
• Negative skin test for hypersensitivity to saccharomyces cerevisiae.

Exclusion Criteria:

• Metastatic pancreas cancer patients
• Unresectable pancreas cancer patients
• Tumor lacks a product-related ras mutation
• History of allergy to S. cerevisiae
• History of Crohn's disease or history compatible with inflammatory bowel disease with presence of anti-S. cerevisiae  antibodies (ASCA)
• Corticosteroid (greater than 10mg per day of prednisone or an equipotent dose of another corticosteroid) or other immunosuppressive therapy within the prior 1 week
• Pregnancy and nursing mothers
• Current or prior history of brain metastases
• History of autoimmune disease

Location and Contact Information:

UNITED STATES:

Alabama

Arizona

Arizona Cancer Center
Department of Surgery
1501 N. Campbell Ave.
Tucson, AZ 85724

Arkansas

Central Arkansas Veterans Hospital
Hemotology/Oncology
4301 West Markham, #508
Little Rock, AR 72205-7199

University of Arkansas for Medical Sciences
Hematology/Oncology
4301 West Markham, #508
Little Rock, AR 72205-7199

California

UCLA Medical Center
UCLA Med-Hemat & Onc
Box 957059, Suite 2333 PVUB
Los Angeles, CA 90095-7059

Tower Cancer Research Foundation
9090 Wilshire Bouldevard
Second Floor
Beverly Hills, CA 90211

University of California San Diego
3855 Health Sciences Dr., MC#0698
LaJolla, CA 92093-0698

Colorado

Rocky Mountain Cancer Center
1800 Williams Street, Suite 200
Denver, CO 80218

Minnesota

Minnesota Oncology Hematology, PA
800 E. 28th St., Suite 405
Minneapolis, MN 55404

Missouri

Washington University School of Medicine
Siteman Cancer Center
660 South Euclid, Box 8056
St. Louis, MO 63110

New York

State University of NY at Stony Brook
Cancer Center
3 Edmund Pellegrino Rd.
Room 2-156
Stony Brook, NY 11794-9446

North Carolina

UNC Lineberger Comprehensive Cancer Center
Protocol Office, CB #7295
Third Floor, Admin Tower
Chapel Hill, NC 27599

Ohio

Ohio State University
General and Gastrointestinal Surgery
Department of Surgery
Room N711 Doan Hall
410 West 10th Avenue
Columbus, OH 43210-1228

South Carolina

Cancer Centers of the Carolinas
65 International Dr.
Greenville, SC 29615

Texas

Baylor College of Medicine
BCM390
Houston, TX 77030

South Texas Oncology & Hematology
7979 Wurzbach Rd., Suite Z309
San Antonio, TX 78229

Texas Oncology, PA
8220 Walnut Hill Ln., Suite 700
Professional Building II
Dallas, TX 75231-4400

The Texas Cancer Center, Dallas Southwest
3555 W. Wheatland Rd.
Dallas, TX 75237

Tyler Cancer Center
910 E. Houston St., Suite 100
Tyler, TX 75702

Washington

Northwest Cancer Specialists, PC
210 SE 136th Avenue
Vancouver, WA 98684

Seattle Cancer Care Alliance
825 Eastlake Ave. East, G4810
Seattle, WA 98109

Washington DC

Georgetown University Medical Center; Lombardi Cancer Center
Division of Hematology/Oncology
3800 Reservoir Road, NW
Washington, DC 20007-2113

Wisconsin

Froedtert Multi-Disciplinary Cancer Clinic
Neoplastic Diseases & Related Disorders
FMLH-East
9200 W. Wisconsin Ave.
Milwaukee, WI 53226