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

Sponsor

GlobeImmune (Industry)

Overall Status

Completed

CT.gov ID

NCT00300950

Collaborator

(none)

176

Enrollment

Locations

Arms

109

Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Biological: GI-4000 Drug: Gemcitabine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, 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.

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Recurrence free time and survival [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

(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

Locations

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