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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300950
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : April 6, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Biological: GI-4000 Drug: Gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Biological: GI-4000
Heat-killed yeast cell transfected with target ras mutation.

Experimental: 2
Gemcitabine with GI-4000
Drug: Gemcitabine

Primary Outcome Measures :
  1. Recurrence free time and survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

(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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300950

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Sponsors and Collaborators

Additional Information:
Responsible Party: GlobeImmune Identifier: NCT00300950     History of Changes
Other Study ID Numbers: GI-4000-02
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by GlobeImmune:
Pancreas Cancer
resected pancreas cancer
non-metastatic pancreas cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents