Clinical trial NCT00300950: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreas Cancer
Keywords: Pancreas Cancer
resected pancreas cancer
non-metastatic pancreas cancer
Lead sponsor: GlobeImmune
Sponsor class: INDUSTRY
First posted: 2006-03-10
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recurrence free time and survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: LaJolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center / Lombardi Cancer Center
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical School
state: Illinois
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Stony Brook
country: United States
facility: State University of NY at Stony Brook
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Dallas
country: United States
facility: The Texas Cancer Center Dallas Southwest
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology & Hematology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Multi-Disciplinary Cancer Clinic
state: Wisconsin
city: Peelamedu, Coimbatore
country: India
facility: PSG Hospitals
state: Tamil Nadu
city: Ponur, Chennai
country: India
facility: Sri Ramchandra Medical College & Research Institute
state: Tamil Nadu
city: Hyderabad
country: India
facility: Indo American Cancer Hospital and Research Centre
city: Mangalore
country: India
facility: KMC Hospital
city: Nagpur
country: India
facility: Govt Medical Colleg & Hospital
city: Nettoor, Cochin
country: India
facility: Lake Shore Hospital & Research Centre
city: New Delhi
country: India
facility: G B Pan Hospital & Maulana Azad Medical College
city: Panjagutta, Hyderaba
country: India
facility: Nizam's Institute of Medical Sciences
city: Perungudi, Chennai
country: India
facility: Lifeline Multispecialty Hospital
city: Trivandrum
country: India
facility: Regional Cancer Centre
Study officials:
References:
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.