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

Withdrawn before enrolling · Phase 1

Conditions studied: Esophageal Neoplasms

In brief

This a pilot clinical study focused on enhancing the patient's anti-tumor immune response in individuals with esophageal cancer by altering the genetic repertoire of the tumors to express CD40L, an activator of dendritic cells. This will be accomplished by endoscopic administration to the tumors of AdcuCD40L, an adenovirus gene transfer vector expressing the coding sequence of the human CD40L cDNA. This study is designed to assess the hypothesis that it is safe to administer the AdcuCD40L vector to individuals with esophageal cancer.

Key facts

Study ID

NCT00328887

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2004-11-01

Expected to finish

2010-07-01

Last updated by the study team

2016-05-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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; stage IIIB or IV; no chemotherapy for 4 weeks prior to vector dosing; and no chemotherapy or radiation for 4 weeks after vector dosing. Patients must have viable tumor in the esophagus (or gastroesophageal junction). In addition, patients must be (1) be untreated; or, (2) show endoscopic evidence of persistence of disease after treatment with conventional chemotherapy, radiotherapy, or both
• 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

You may not qualify if…

• Individuals who do not meet the inclusion criteria will be unable to participate in the protocol
• 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 wk) cerebral vascular accident
• Recent (less than 6 wk) 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)
• Lack of viable esophageal tumor (applies only to pretreated patients)
• Pathology other than squamous cell or adenocarcinoma
• Malignant ventricular arrhythmia
• Pregnancy
• Immunodeficiency disease, including evidence of HIV infection
• Current alcohol or drug abuse

Where it is running

• The Valley Hospital — Ridgewood, New Jersey, United States
• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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