Esophageal Cancer Clinical Trial
Official title:
A Single Arm, Phase II Study of TNFerade™ Biologic Gene Therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer
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.
n/a
Primary Purpose: Treatment
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