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.

First Received on March 8, 2006. Last Updated on September 14, 2011 History of Changes

Sponsor:	GlobeImmune
Information provided by (Responsible Party):	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:	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:

Genetics Home Reference related topics: Help Me Understand Genetics

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 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

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

Show 28 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
ClinicalTrials.gov Identifier:	NCT00300950 History of Changes
Other Study ID Numbers:	GI-4000-02
Study First Received:	March 8, 2006
Last Updated:	September 14, 2011
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 February 12, 2012