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

Phase 2

Completed

• Conditions: Pancreas Cancer
• Interventions: Drug: Gemcitabine; Biological: GI-4000

• Registration Number: NCT00300950
• Lead Sponsor: GlobeImmune

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Gemcitabine	Gemcitabine with GI-4000
1	GI-4000	Gencitabine

Primary Outcome Measures

Name	Time	Method
Recurrence free time and survival	5 years

Trial Locations

Locations (28)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Tower Cancer Research Foundation; 🇺🇸 Beverly Hills, California, United States

University of California San Diego; 🇺🇸 LaJolla, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Georgetown University Medical Center / Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Rush University Medical School; 🇺🇸 Chicago, Illinois, United States

Minnesota Oncology Hematology, PA; 🇺🇸 Minneapolis, Minnesota, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

State University of NY at Stony Brook; 🇺🇸 Stony Brook, New York, United States

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States

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