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TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

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

NCT00137878•GenVec

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (1)

Center for Cancer Research, NCI

Bethesda, Maryland, United States

Key Dates

Last Updated

February 23, 2012

Conditions

Rectal Cancer

Interventions

TNFerade™

DRUG

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NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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