Status:
WITHDRAWN
Safety Study on the Transfer of the CD40 Ligand Gene (AdcuCD40L) to Patients With Esophageal Carcinoma
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 ac...
Detailed Description
Esophageal cancer is a deadly disease, with only slow advances in therapy over several decades, despite a rapid increase in incidence. Esophageal cancer is estimated to be the seventh most common mali...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00328887
Start Date
November 1 2004
End Date
July 1 2010
Last Update
May 3 2016
Active Locations (2)
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1
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
2
Weill Medical College of Cornell University
New York, New York, United States, 10021