Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Status:
Withdrawn
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
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.