A Single Arm, Phase II Study of TNFerade™ Biologic Gene Therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer
Inclusion Criteria
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.