Spots Global Cancer Trial Database for Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
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Trial Identification
Brief Title: Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Official Title: Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Study ID: NCT00181220
Conditions
Interventions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Johns Hopkin Singapore International Medical Center, Singapore, , Singapore
Contact Details
Name: Wen-son Hsieh, M.D.
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
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