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TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer
This study is ongoing, but not recruiting participants.
First Received: August 26, 2005   Last Updated: May 20, 2009   History of Changes
Sponsor: GenVec
Information provided by: GenVec
ClinicalTrials.gov Identifier: NCT00137878
  Purpose

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 II

Study Type: Interventional
Study Design: Treatment, Randomized
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:

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00137878

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

No publications provided

Study ID Numbers: GV-001.007
Study First Received: August 26, 2005
Last Updated: May 20, 2009
ClinicalTrials.gov Identifier: NCT00137878     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009