Study of TNFerade™ Gene Therapy, Radiation, 5-FU and Cisplatin in Esophageal Cancer
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00051480
- Lead Sponsor
- GenVec
- Brief Summary
The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™ with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells.
TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy fractions for 5 weeks.
- 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 (12)
St. Louis University
🇺🇸St. Louis, Missouri, United States
US Oncology, Mary Crowley Center
🇺🇸Dallas, Texas, United States
UCSD Cancer Center
🇺🇸La Jolla, California, United States
Palo Alto VA Health Care Systems
🇺🇸Palo Alto, California, United States
Johns Hopkins School of Medicine
🇺🇸Baltimore, Maryland, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Medical College of Virginia
🇺🇸Richmond, Virginia, United States
University of California, Irvine
🇺🇸Orange, California, United States
University of Texas/MD Anderson
🇺🇸Houston, Texas, United States
Scott & White Center for Cancer Prevention and Care
🇺🇸Temple, Texas, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States