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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300950
First Posted: March 10, 2006
Last Update Posted: April 6, 2015
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.
Information provided by (Responsible Party):
GlobeImmune
  Purpose
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 Intervention Phase
Pancreas Cancer Biological: GI-4000 Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by GlobeImmune:

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

Enrollment: 176
Study Start Date: January 2006
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

(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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00300950


  Show 28 Study Locations
Sponsors and Collaborators
GlobeImmune
  More Information

Additional Information:
Responsible Party: GlobeImmune
ClinicalTrials.gov Identifier: NCT00300950     History of Changes
Other Study ID Numbers: GI-4000-02
First Submitted: March 8, 2006
First Posted: March 10, 2006
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
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Pancrelipase
Pancreatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents