This study is currently closed.

Summary

GI-4000 will be administered under the skin (subcutaneously) to patients to evaluate the inital safety and immune system responses associated with  escalating doses of the product.

Overview

Patients with solid tumors commonly having mutations at codons 12 and 61 of the ras  oncogene, including pancreatic, colorectal and non-small cell lung cancers will be screened for eligibility for this study.  Patient tumor biopsy or surgical specimens 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 will be injected under the skin (subcutaneous injection) of the patient.  The study is currently enrolling at the highest dose level (40YU); patients will receive five weekly injections over a 28 day period (Single injection on Day 1,  plus weekly single injections thereafter) and will be monitored to evaluate the safety of GI-4000.   Patients will be monitored for three months for safety, immune responses and any therapeutic benefits related to the injections.

Official Title:

A Phase I Open Label, Non-randomized, Dose-escalation, Multi-center, Therapeutic Trial of the Safety, Immunogenicity, and Efficacy of GI-4000, an Inactivated Recombinant Saccharomyces cerevisiae Immunotherapeutic Expressing Three Different Mutations of the Ras Oncoprotein, in Patients with Solid Tumors Expressing Mutations in Ras.

Study Details:

Eligibility

Inclusion Criteria:

• Inoperable Stage III or Stage IV disease; colorectal, pancreas or non-small cell lung cancer
• Availability of tumor tissue for sequencing (either fresh tissue or paraffin block)
• Presence of a ras mutation at codon 12 or 61 which is contained in one of the GI-4000 products
• Refractory to at least one regimen of best currently available chemotherapy, radiotherapy or both;
• ECOG Performance Score 0 or 1
• Negative skin test for hypersensitivity to saccharomyces cerevisiae.

Exclusion Criteria:

• 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
• HIV+, Hepatitis BsAg +, Hepatitis C  Ab+
• History of autoimmune disease

Location and Contact Information:

Colorado

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

University of Colorado Cancer Center
Anschutz Outpatient Pavilion
1635 N. Ursula St., Third Floor
Aurora, CO 80010

North Carolina

Duke University Medical Center
Duke South Clinics
Durham NC 27710

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

Washington

Fred Hutchinson Cancer Research Center
University of Washington Medical Center
825 Eastlake Avenue East, G4810
Seattle, WA 98109