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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

Primary Purpose

Pancreas Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GI-4000
Gemcitabine
Sponsored by
GlobeImmune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreas Cancer, resected pancreas cancer, non-metastatic pancreas cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Tower Cancer Research Foundation
  • University of California San Diego
  • UCLA Medical Center
  • Georgetown University Medical Center / Lombardi Cancer Center
  • Rush University Medical School
  • Minnesota Oncology Hematology, PA
  • Washington University
  • State University of NY at Stony Brook
  • UNC Lineberger Comprehensive Cancer Center
  • Ohio State University
  • Texas Oncology, PA
  • The Texas Cancer Center Dallas Southwest
  • Baylor College of Medicine
  • South Texas Oncology & Hematology
  • Tyler Cancer Center
  • Seattle Cancer Care Alliance
  • Froedtert Multi-Disciplinary Cancer Clinic
  • PSG Hospitals
  • Sri Ramchandra Medical College & Research Institute
  • Indo American Cancer Hospital and Research Centre
  • KMC Hospital
  • Govt Medical Colleg & Hospital
  • Lake Shore Hospital & Research Centre
  • G B Pan Hospital & Maulana Azad Medical College
  • Nizam's Institute of Medical Sciences
  • Lifeline Multispecialty Hospital
  • Regional Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Gencitabine

Gemcitabine with GI-4000

Outcomes

Primary Outcome Measures

Recurrence free time and survival

Secondary Outcome Measures

Full Information

First Posted
March 8, 2006
Last Updated
April 2, 2015
Sponsor
GlobeImmune
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1. Study Identification

Unique Protocol Identification Number
NCT00300950
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlobeImmune

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Pancreas Cancer, resected pancreas cancer, non-metastatic pancreas cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Gencitabine
Arm Title
2
Arm Type
Experimental
Arm Description
Gemcitabine with GI-4000
Intervention Type
Biological
Intervention Name(s)
GI-4000
Intervention Description
Heat-killed yeast cell transfected with target ras mutation.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Recurrence free time and survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of California San Diego
City
LaJolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Georgetown University Medical Center / Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Rush University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
State University of NY at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Texas Oncology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The Texas Cancer Center Dallas Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Oncology & Hematology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Froedtert Multi-Disciplinary Cancer Clinic
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
PSG Hospitals
City
Peelamedu, Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641004
Country
India
Facility Name
Sri Ramchandra Medical College & Research Institute
City
Ponur, Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Facility Name
Indo American Cancer Hospital and Research Centre
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
KMC Hospital
City
Mangalore
ZIP/Postal Code
575001
Country
India
Facility Name
Govt Medical Colleg & Hospital
City
Nagpur
Country
India
Facility Name
Lake Shore Hospital & Research Centre
City
Nettoor, Cochin
ZIP/Postal Code
682304
Country
India
Facility Name
G B Pan Hospital & Maulana Azad Medical College
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Panjagutta, Hyderaba
ZIP/Postal Code
500082
Country
India
Facility Name
Lifeline Multispecialty Hospital
City
Perungudi, Chennai
ZIP/Postal Code
600096
Country
India
Facility Name
Regional Cancer Centre
City
Trivandrum
ZIP/Postal Code
695011
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
33786412
Citation
Muscarella P, Bekaii-Saab T, McIntyre K, Rosemurgy A, Ross SB, Richards DA, Fisher WE, Flynn PJ, Mattson A, Coeshott C, Roder H, Roder J, Harrell FE, Cohn A, Rodell TC, Apelian D. A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. J Pancreat Cancer. 2021 Mar 23;7(1):8-19. doi: 10.1089/pancan.2020.0021. eCollection 2021.
Results Reference
derived

Learn more about this trial

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

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