Clinical Trials

Toll-Free: 866.320.4573

Call Us Toll Free:

866.223.2273 x1234

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

Study:

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

Rationale:

n/a

Purpose:

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 Status: Recruiting

Recruiting:
Shelley Robinson 216-444-9668 robinss@ccf.org

Condition Intervention Phase
Pancreatic Cancer Genetic: TNFerade Phase 3

Verified by GenVec December, 2008

Sponsored by: GenVec
Information provided by: GenVec
ClinicalTrials.gov identifier: NCT00051467

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Safety/Efficacy Study

Cleveland Clinic Foundation
Cleveland, Ohio
United States

n/a

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

Cleveland Clinic Mobile Site