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

Completed · Phase 2

Conditions studied: Pancreas Cancer

In brief

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.

Key facts

Study ID

NCT00300950

Run by

GlobeImmune

People needed

176

Starts

2006-01-01

Expected to finish

2015-02-01

Last updated by the study team

2015-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Metastatic pancreas cancer patients post-resection
• Patients with no product-related ras mutation.

Where it is running

• 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

Full record on ClinicalTrials.gov

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