Study of TNFerade™ Gene Therapy, Radiation, 5-FU and Cisplatin in Esophageal Cancer

Inclusion criteria:

* 18-75 years for age;
* Patients with biopsy proven locally advanced adenocarcinoma or squamous cell carcinoma of the esophagus, stage II, III, who have not received previous treatment and are considered to have resectable carcinoma;
* Informed consent;
* Karnofsky performance status ≥ 70%;
* Life expectancy greater than 6 months.

Exclusion criteria:

* Diagnosis of lymphoma of the esophagus;
* History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer or localized early stage prostate cancer with patients continuously disease-free;
* Previous chemotherapy or radiation for esophageal cancer or previous radiation therapy to the target field;
* T4 disease, metastatic (stage IV) disease or confirmed invasion of the bronchial tree;
* Extension beyond 2 cm into stomach;
* Liver enzymes \>2.0 x ULN (ALT, AST, bilirubin, alkaline phosphatase);
* Coagulopathy (INR \>1.5, PTT ratio \>1.5);
* Renal insufficiency (creatinine \>2.0 mg/dL; calculated creatinine clearance \<50 ml/min);
* Significant anemia (hematocrit \<28% or hemoglobin \<9 g/dL) (may have RBC transfusion), or thrombocytopenia (platelet count \<100,000/μL)l or leukopenia (WBC \<3,000/µL; ANC \<1,500 μL);
* Contraindication to endoscopic or EUS-guided delivery including obstructive lesions that can not be dilated to pass endoscope;
* Clinical evidence of active infection of any type, including hepatitis B or C virus;
* Due to the embryotoxic effects of chemotherapy, pregnant or lactating women, or men unable or unwilling to practice contraception are excluded;
* Experimental medications within the last four weeks prior to Day 1;
* Chronic systemic corticosteriod use (orally or parenterally administered);
* Significant concurrent medical or psychiatric illness as defined by the investigator.