Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041626
Status:
UNKNOWN
Last Update Posted:
2007-09-11
First Post:
2002-07-11
Brief Title:
Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
Sponsor:
Introgen Therapeutics
Organization:
Introgen Therapeutics
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
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:
There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck SCCHN These tumors usually have a variety of genetic defects that include disruption of the p53 pathway a pathway that would ordinarily work to prevent the development of tumors In this study the transfer of the p53 gene to tumor cells using a modified adenovirus INGN 201 in combination with chemotherapy cisplatin and fluorouracil will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy
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