TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

This study has been completed.
Information provided by:
GenVec Identifier:
First received: August 26, 2005
Last updated: February 22, 2012
Last verified: May 2011

The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.

Condition Intervention Phase
Rectal Cancer
Drug: TNFerade™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial Comparing TNFerade™ Biologic With Capecitabine and Radiation Therapy Followed by Surgical Resection Versus Capecitabine and Radiation Therapy Followed by Surgical Resection for the Treatment of Rectal Cancer

Resource links provided by NLM:

Further study details as provided by GenVec:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Inclusion Criteria:

  • All patients who have biopsy proven T3 or T4 rectal cancer which is confined to the primary tumor site with or without regional lymph node involvement
  • Patients must be willing to return for follow-up
  • Patients must be able to give and sign informed consent
  • Patients must be suitable candidates for surgical resection post-chemoradiation, i.e. no history of severe congestive heart failure or severe pulmonary disease
  • Life expectancy > 6 months

Exclusion Criteria:

  • Patients with evidence of distant metastatic disease
  • Any of the following hematologic abnormalities: hemoglobin (HGB) < 8.0 gm/dL unable to be corrected with a transfusion; absolute neutrophil count (ANC) < 1500 cells/mm3; platelets < 100,000/mm3; activated partial thromboplastin time (APTT) ratio or International Normalized Ratio (INR) > 1.5 (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for vector injection or surgery).
  • A history of hepatic cirrhosis or present hepatic dysfunction with total bilirubin > 2.0 mg/dL except for patients with Gilbert's syndrome who must have a direct bilirubin </= 1.0 mg/dL; AST/ALT >/= 2.5 times upper limit of normal.
  • Renal insufficiency as determined by a serum creatinine > 2.0 mg/dL
  • Patients may not have received prior therapy with chemotherapy, biologic therapy or radiation therapy for rectal cancer
  • Significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease
  • Concurrent second malignancy requiring systemic therapy
  • Pregnant or lactating women
  • Chronic systemic corticosteroid use
  • Prior surgery for rectal cancer
  • Patients with history of deep venous thrombosis or pulmonary embolism
  • Patients with Doppler evidence of deep venous thrombosis at screening
  • Known history of documented coagulopathy or thrombophilic disorders
  • Hormone replacement therapy within one month prior to Day 1
  • Known history of documented cerebrovascular disease, stroke or transient ischemic attack (TIA)
  • Surgery within the last one month, excluding diverting colostomy or ileostomy for obstruction
  Contacts and Locations
Please refer to this study by its identifier: NCT00137878

United States, Maryland
Center for Cancer Research, NCI
Bethesda, Maryland, United States
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

Responsible Party: Paul Fischer, PhD, GenVec Identifier: NCT00137878     History of Changes
Obsolete Identifiers: NCT00069147, NCT00072241
Other Study ID Numbers: GV-001.007
Study First Received: August 26, 2005
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 15, 2014