Efficacy Study on the Transfer of Adenovirus With the CD40 Ligand Gene (AdcuCD40L) to Patients With Esophageal Carcinoma

Inclusion Criteria

• •Must be capable of providing informed consent
• •Males and females, age 18 to 75 years
• •Hematocrit \> 30%
• •WBC \< 10,000
• •Normal prothrombin, partial thromboplastin time; platelet count \> 100,000
• •Normal liver-related serum parameters
• •Blood urea nitrogen \< 60 mg/dL, creatinine \< 2.5 mg/dl
• •No evidence of active infection of any type, including with adenovirus, hepatitis virus (A, B or C), or human immunodeficiency virus
• •No evidence of central nervous system, major psychiatric, musculoskeletal, or immune disorder
• •No allergy to the vehicle used to suspend the virus or contrast materials used in radiographic procedures
• •Fertile or infertile individuals; it will be recommended that fertile individuals utilize barrier birth control measures to prevent pregnancy during and for 1 month following the administration of the vector
• •Biopsy proven esophageal cancer; clinically stage I-III, deemed resectable by the patient's surgeon. No history of neoadjuvant chemotherapy or chemoradiotherapy. Distant metastases are to be ruled out at the discretion of the physician treating the patient according to standards of care
• •Individuals not receiving experimental medications or participating in another experimental protocol for at least 4 weeks prior to entry to the study
• •The study individual must be able to undergo the procedures in the protocol
• •Willingness to participate in the study
• •Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
• •Individuals receiving corticosteroids or other immunosuppressive medications; previous splenectomy or radiation to the spleen; autoimmune disease
• •Recent (less than 6 week) cerebral vascular accident
• •Recent (less than 6 week) transmural myocardial infarction
• •Evidence of infection defined by elevated white blood cell count, temperature \> 38.5oC or infiltrate on chest x-ray
• •Cervical esophageal cancer
• •Gastric cancer (tumor more than 50% in the stomach as determined by endoscopy)
• •Pathology other than squamous cell or adenocarcinoma
• •Malignant ventricular arrhythmia
• •Pregnancy
• •Immunodeficiency disease, including evidence of HIV infection
• •Current alcohol or drug abuse
• •Esophageal tumor too small for adequate tissue harvest (determined during esophagoscopy at the time of vector or placebo injection)