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Bethesda, Maryland

  • Rectal Cancer


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.


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



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Bethesda, Maryland
United States

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Site Status: N/A

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Date Processed: March 26, 2020

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