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