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 - Full Text View

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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancreatin Pancrelipase Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by GlobeImmune:

Primary Outcome Measures:

Recurrence free time and survival [ Time Frame: 5 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

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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
University of California San Diego
LaJolla, California, United States, 92093
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, District of Columbia
Georgetown University Medical Center / Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Illinois
Rush University Medical School
Chicago, Illinois, United States, 60612
United States, Minnesota
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
State University of NY at Stony Brook
Stony Brook, New York, United States, 11794
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
Texas Oncology, PA
Dallas, Texas, United States, 75231
The Texas Cancer Center Dallas Southwest
Dallas, Texas, United States, 75237
Baylor College of Medicine
Houston, Texas, United States, 77030
South Texas Oncology & Hematology
San Antonio, Texas, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
Froedtert Multi-Disciplinary Cancer Clinic
Milwaukee, Wisconsin, United States, 53226
India
PSG Hospitals
Peelamedu, Coimbatore, Tamil Nadu, India, 641004
Sri Ramchandra Medical College & Research Institute
Ponur, Chennai, Tamil Nadu, India, 600116
Indo American Cancer Hospital and Research Centre
Hyderabad, India, 500034
KMC Hospital
Mangalore, India, 575001
Govt Medical Colleg & Hospital
Nagpur, India
Lake Shore Hospital & Research Centre
Nettoor, Cochin, India, 682304
G B Pan Hospital & Maulana Azad Medical College
New Delhi, India, 110002
Nizam's Institute of Medical Sciences
Panjagutta, Hyderaba, India, 500082
Lifeline Multispecialty Hospital
Perungudi, Chennai, India, 600096
Regional Cancer Centre
Trivandrum, India, 695011

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:	May 15, 2013
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 May 23, 2013