TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

Status:

COMPLETED

TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

Lead Sponsor:

GenVec

Conditions:

Rectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 chemoradi...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00137878

Last Update

February 23 2012

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