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

This study has been completed.
Sponsor:
Information provided by:
GenVec
ClinicalTrials.gov Identifier:
NCT00051480
First received: January 10, 2003
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Esophageal Cancer
Genetic: TNFerade
Phase 2

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by GenVec:

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051480

Locations
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
GenVec
  More Information

No publications provided by GenVec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Fischer, PhD, GenVec
ClinicalTrials.gov Identifier: NCT00051480     History of Changes
Other Study ID Numbers: GV-001.005
Study First Received: January 10, 2003
Last Updated: May 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 18, 2014