Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496535
Status:
COMPLETED
Last Update Posted:
2012-02-23
First Post:
2007-07-02
Brief Title:
A Study of TNFerade Biologic With Concomitant Radiotherapy Fluorouracil and Hydroxyurea TNF-FHX in Patients With Head and Neck Cancer
Sponsor:
GenVec
Organization:
GenVec
Study Overview
Official Title:
A Phase III Safety Tolerability and Proof of Concept Study of TNFerade Biologic in Combination With Concomitant Radiotherapy Fluorouracil and Hydroxyurea TNF-FHX for Patients With Unresectable Recurrent Head and Neck 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 objective of the first phase is to determine the safety the maximum tolerated dose MTD and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil 5FU Hydroxyurea HU and standard daily radiotherapy in patients with recurrent head and neck cancer RHNC All chemoradiotherapy is administered on a week-onweek-off schedule The primary objective of the second phase II is to determine the locoregional control rate at 24 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GV-001011 TNF-CORE | None | None | None |