The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic cancer. TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to tumor cells. TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection using a percutaneous approach (PTA) or endoscopic ultrasound (EUS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
University of California San Diego Moores Cancer Center
La Jolla, California, United States
UCLA School of Medicine, Division of Hematology-Oncology
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
University of Colorado Health Science Center Facility
Denver, Colorado, United States
Georgetown, MedStar Research Institute
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Winship Cancer Center, Emory University
Atlanta, Georgia, United States
The Universtiy of Chicago Medical Center
Chicago, Illinois, United States
St. James Hospital and Health Centers Comprehensive Cancer Institute
Olympia Fields, Illinois, United States
...and 15 more locations
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