COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00051480
Recruitment Status : Completed
First Posted : January 13, 2003
Last Update Posted : May 12, 2011
Information provided by:

Brief Summary:

The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™ with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells.

TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy fractions for 5 weeks.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Genetic: TNFerade Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Single Arm, Phase II Study of TNFerade™ Biologic Gene Therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00051480

Layout table for location information
United States, California
UCSD Cancer Center
La Jolla, California, United States, 92093-0064
University of California, Irvine
Orange, California, United States, 92868
Palo Alto VA Health Care Systems
Palo Alto, California, United States, 94304
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637-1470
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21231-2410
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63110
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
US Oncology, Mary Crowley Center
Dallas, Texas, United States, 75246
University of Texas/MD Anderson
Houston, Texas, United States, 77030-4009
Scott & White Center for Cancer Prevention and Care
Temple, Texas, United States, 76508
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23298-0058
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Paul Fischer, PhD, GenVec Identifier: NCT00051480    
Other Study ID Numbers: GV-001.005
First Posted: January 13, 2003    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases