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 currently recruiting participants.

Verified by GlobeImmune, April 2009

First Received: March 8, 2006 Last Updated: April 14, 2009 History of Changes

Sponsor:	GlobeImmune
Information provided by:	GlobeImmune
ClinicalTrials.gov Identifier:	NCT00300950

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride Ultrase

U.S. FDA Resources

Further study details as provided by GlobeImmune:

Primary Outcome Measures:

Recurrence free time and survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2006
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Gencitabine	Biological: GI-4000 Heat-killed yeast cell transfected with target ras mutation.
2: Experimental 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

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

Contacts

Contact: John Ferraro

303-625-2733

Show 44 Study Locations

Sponsors and Collaborators

GlobeImmune

More Information

Additional Information:

Sponsor website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	GlobeImmune, Inc. ( John Ferraro MBA Director Clinical Operations )
Study ID Numbers:	GI-4000-02
Study First Received:	March 8, 2006
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00300950 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009