Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051467
Status:
COMPLETED
Last Update Posted:
2012-02-23
First Post:
2003-01-10
Brief Title:
A Study of TNFerade Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Sponsor:
GenVec
Organization:
GenVec
Study Overview
Official Title:
A Randomized Phase IIIII Study of TNFerade Biologic With 5-FU and Radiation Therapy for First-line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None