TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: TNFerade™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TNFerade™|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |