Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051480
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2003-01-10
Brief Title:
Study of TNFerade Gene Therapy Radiation 5-FU and Cisplatin in Esophageal Cancer
Sponsor:
GenVec
Organization:
GenVec
Study Overview
Official Title:
A Single Arm Phase II Study of TNFerade Biologic Gene Therapy Radiation 5-FU and Cisplatin in Locally Advanced Resectable Esophageal 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 feasibility of giving TNFerade with 5-FU Cisplatin and radiation therapy to patients with locally advanced esophageal cancer prior to surgical resection TNFerade is a replication deficient E1 E3 and E4 deleted adenovirus vector containing the gene for TNF-alpha controlled by a radiation inducible promoter This allows the expression of TNF-alpha to be greatest in the area receiving radiation TNF-alpha is a potent cytokine that has been shown to have potent anti-cancer activities but due to systemic toxicity could not be delivered at effective doses TNFerade is a novel way of selective delivery of TNF-alpha to tumor cells
TNFerade will be delivered once a week for five weeks by direct intratumoral injection by using endoscopy or Endoscopic Ultrasound 5-FU 1000 mgm2day will be delivered via continuous infusion for 96 hours during weeks 1 and 4 Cisplatin 75 mgm2 will be delivered on Day 1 and Day 29 intravenously The dose of radiation delivered will be 45 Gy in 18 Gy fractions for 5 weeks
TNFerade will be delivered once a week for five weeks by direct intratumoral injection by using endoscopy or Endoscopic Ultrasound 5-FU 1000 mgm2day will be delivered via continuous infusion for 96 hours during weeks 1 and 4 Cisplatin 75 mgm2 will be delivered on Day 1 and Day 29 intravenously The dose of radiation delivered will be 45 Gy in 18 Gy fractions for 5 weeks
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