A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00051467
- Lead Sponsor
- GenVec
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
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, 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
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