Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT00181220
Status:
WITHDRAWN
Last Update Posted:
2020-05-18
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Sponsor:
Johns Hopkins University
Organization:
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WITHDRAWN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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: