TNFerade combined with chemoradiation in resectable esophageal cancer

3197 Background: TNFerade is a second-generation replication deficient adenovector, carrying the transgene encoding for human TNFα, regulated by the radiation-inducible promoter Egr-1. A dose-escalating study was initiated to demonstrate feasibility, safety and tolerability of TNFerade combined with chemoradiotherapy in patients receiving preoperative chemoradiation for resectable esophageal cancer. An additional aim of this study was to select the dose of TNFerade for phase II evaluations. Methods: TNFerade was administered weekly x 5 concurrently with radiotherapy (45 Gy) and 5-FU (1000 mg/m2/day for 96 hrs on Day 1 and Day 29) plus cisplatin (75 mg/ m2 on Day 1 and Day 29). TNFerade was administered via endoscopic intratumoral injection, using ultrasound guided injection or endoscopic injection according to study site preference. The study endpoints were safety, feasibility, and response rate, assessed by histopathologic evaluation of resection specimens. Results: 11 patients have been treated in the 4...