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
NCT ID: NCT00300950
Last Updated: 2015-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2006-01-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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1
Gencitabine
GI-4000
Heat-killed yeast cell transfected with target ras mutation.
2
Gemcitabine with GI-4000
Gemcitabine
Chemotherapy
Interventions
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GI-4000
Heat-killed yeast cell transfected with target ras mutation.
Gemcitabine
Chemotherapy
Eligibility Criteria
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Inclusion Criteria
* \>18 years of age
* Negative skin test for hypersensitivity to Saccharomyces cerevisiae
Exclusion Criteria
* Patients with no product-related ras mutation.
18 Years
ALL
No
Sponsors
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GlobeImmune
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
University of California San Diego
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Georgetown University Medical Center / Lombardi Cancer Center
Washington D.C., 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
Ohio State University
Columbus, Ohio, United States
Texas Oncology, PA
Dallas, Texas, United States
The Texas Cancer Center Dallas Southwest
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
South Texas Oncology & Hematology
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Froedtert Multi-Disciplinary Cancer Clinic
Milwaukee, Wisconsin, United States
PSG Hospitals
Peelamedu, Coimbatore, Tamil Nadu, India
Sri Ramchandra Medical College & Research Institute
Ponur, Chennai, Tamil Nadu, India
Indo American Cancer Hospital and Research Centre
Hyderabad, , India
KMC Hospital
Mangalore, , India
Govt Medical Colleg & Hospital
Nagpur, , India
Lake Shore Hospital & Research Centre
Nettoor, Cochin, , India
G B Pan Hospital & Maulana Azad Medical College
New Delhi, , India
Nizam's Institute of Medical Sciences
Panjagutta, Hyderaba, , India
Lifeline Multispecialty Hospital
Perungudi, Chennai, , India
Regional Cancer Centre
Trivandrum, , India
Countries
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References
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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.
Other Identifiers
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GI-4000-02
Identifier Type: -
Identifier Source: org_study_id
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