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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlobeImmune
ClinicalTrials.gov Identifier:
NCT00300950
First received: March 8, 2006
Last updated: May 27, 2014
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Enrollment: 176
Study Start Date: January 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300950

  Show 28 Study Locations
Sponsors and Collaborators
GlobeImmune
  More Information

Additional Information:
No publications provided

Responsible Party: GlobeImmune
ClinicalTrials.gov Identifier: NCT00300950     History of Changes
Other Study ID Numbers: GI-4000-02
Study First Received: March 8, 2006
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

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
Pancrelipase
Gemcitabine
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
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
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014