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 2008

Sponsored by:	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	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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.

Further study details as provided by GlobeImmune:

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

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 43 Study Locations

Sponsors and Collaborators

GlobeImmune

More Information

Sponsor website This link exits the ClinicalTrials.gov site

Study ID Numbers:	GI-4000-02
Study First Received:	March 8, 2006
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00300950
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlobeImmune:

Pancreas Cancer
resected pancreas cancer
non-metastatic pancreas cancer

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009