Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181220
Status:
WITHDRAWN
Last Update Posted:
2020-05-18
First Post:
2005-09-13
Brief Title:
Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left JHU and is not able to be reached for updates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study will test the safety and efficacy of sodium valproate in the induction of Epstein-Barr virus EBV lytic cycle antigen expression in tumor tissue of patients undergoing primary therapy for nasopharyngeal carcinoma Up to 20 patients will be given valproic acid for 2 weeks The primary surrogate endpoint for efficacy will be expression of EBV lytic antigens by immunohistochemistry in tumor tissue Biopsies of primary tumor will be taken after 2 weeks with achievement of a therapeutic concentration of valproate Expression of immunodominant EBV latency antigens in tumor tissue EBV viral load by real time PCR and valproate levels will be measured Adverse events associated with valproate in NPC patients will be described
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