Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer

April 2, 2015 updated by: GlobeImmune

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.

The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

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

  • India
      • Hyderabad, India, 500034
        • Indo American Cancer Hospital and Research Centre
      • Mangalore, India, 575001
        • KMC Hospital
      • Nagpur, India
        • Govt Medical Colleg & Hospital
      • Nettoor, Cochin, India, 682304
        • Lake Shore Hospital & Research Centre
      • New Delhi, India, 110002
        • G B Pan Hospital & Maulana Azad Medical College
      • Panjagutta, Hyderaba, India, 500082
        • Nizam's Institute of Medical Sciences
      • Perungudi, Chennai, India, 600096
        • Lifeline multispecialty Hospital
      • Trivandrum, India, 695011
        • Regional Cancer Centre
    • Tamil Nadu
      • Peelamedu, Coimbatore, Tamil Nadu, India, 641004
        • PSG Hospitals
      • Ponur, Chennai, Tamil Nadu, India, 600116
        • Sri ramchandra Medical College & Research Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
      • LaJolla, California, United States, 92093
        • University of California San Diego
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center / Lombardi Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical School
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, PA
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • Stony Brook, New York, United States, 11794
        • State University of NY at Stony Brook
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Oncology, PA
      • Dallas, Texas, United States, 75237
        • The Texas Cancer Center Dallas Southwest
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229
        • South Texas Oncology & Hematology
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Multi-Disciplinary Cancer Clinic

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

(A few general items required)

Inclusion Criteria:

  • Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation
  • >18 years of age
  • Negative skin test for hypersensitivity to Saccharomyces cerevisiae

Exclusion Criteria:

  • Metastatic pancreas cancer patients post-resection
  • Patients with no product-related ras mutation.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Gencitabine
Biological: GI-4000
Heat-killed yeast cell transfected with target ras mutation.
Experimental: 2
Gemcitabine with GI-4000
Drug: Gemcitabine
Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence free time and survival
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

GlobeImmune

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2006

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 8, 2006

First Submitted That Met QC Criteria

March 8, 2006

First Posted (Estimate)

March 10, 2006

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-4000-02

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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