TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

NCT00137878 | Completed Phase 2

• 1 other identifier: GV-001.007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.

Conditions

Rectal Cancer

Interventions

TNFerade™ DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GenVec: lead

Study Sites (1)

Center for Cancer Research, NCI

Bethesda, Maryland, United States

Location

Related Links

• PubMed.gov

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Last Updated: February 23, 2012

Record last verified: 2011-05

Locations

US (1)