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Completed Phase 3 Interventional

A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer

ClinicalTrials.gov ID: NCT00051467

Public ClinicalTrials.gov record NCT00051467. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Phase II/III, Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-line Treatment of Unresectable Locally Advanced Pancreatic Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic cancer. TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to tumor cells. TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection using a percutaneous approach (PTA) or endoscopic ultrasound (EUS).

Study identification

NCT ID
NCT00051467
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GenVec
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Genetic

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Feb 23, 2012

United States locations

U.S. sites
25
U.S. states
18
U.S. cities
23
Facility City State ZIP Site status
University of California San Diego Moores Cancer Center La Jolla California — —
UCLA School of Medicine, Division of Hematology-Oncology Los Angeles California — —
UC Irvine Medical Center Orange California — —
University of Colorado Health Science Center Facility Denver Colorado — —
Georgetown, MedStar Research Institute Washington D.C. District of Columbia — —
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida — —
Tampa General Hospital Tampa Florida — —
Winship Cancer Center, Emory University Atlanta Georgia — —
The Universtiy of Chicago Medical Center Chicago Illinois — —
St. James Hospital and Health Centers Comprehensive Cancer Institute Olympia Fields Illinois — —
Indiana University Medical Goup Indianapolis Indiana — —
Johns Hopkins Medical Center Baltimore Maryland — —
Beth Israel Deaconess Medical Center Boston Massachusetts — —
Wayne State University, Karmanos Cancer Institute Detroit Michigan — —
Research Medical Center Kansas City Missouri — —
Washington University St Louis Missouri — —
Beth Israel Medical Center, BI Cancer Center New York New York — —
Leo W. Jenkins Cancer Center Greenville North Carolina — —
Cancer Centers of the Carolinas Greenville South Carolina — —
Mary Crowley Medical Center Dallas Texas — —
Univeristy of Texas Southwestern Medical Center Dallas Texas — —
Baylor College of Medicine Houston Texas — —
Virginia Commonwealth University Richmond Virginia — —
Virginia Mason Medical Center Seattle Washington — —
University of Wisconsin, Division of Neoplastic Diseases & Related Disorders Milwaukee Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00051467, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 23, 2012 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00051467 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →