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A Single Arm, Phase II Study of TNFerade™ Biologic Gene Therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

A Single Arm, Phase II Study of TNFerade™ Biologic Gene Therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer

Inclusion 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

GV-001.005

NCT ID:

NCT00051480

Start Date:

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Johns Hopkins School of Medicine Baltimore, Maryland  21205
University Hospitals of Cleveland Cleveland, Ohio  44106
Tyler Cancer Center Tyler, Texas  75702
Medical College of Virginia Richmond, Virginia  23298-0341
The University of Chicago Medical Center Chicago, Illinois  60637-1470
University of California, Irvine Orange, California  92868
UCSD Cancer Center La Jolla, California  92093-0064
Palo Alto VA Health Care Systems Palo Alto, California  94304
St. Louis University St. Louis, Missouri  63110
US Oncology, Mary Crowley Center Dallas, Texas  75246
University of Texas/MD Anderson Houston, Texas  77030-4009
Scott & White Center for Cancer Prevention and Care Temple, Texas  76508