Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT00181220
Recruitment Status :
(PI left JHU and is not able to be reached for updates)
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All subjects must fulfill the following criteria to be eligible for study admission:
Subjects are of age 18 years and above
Biopsy proven nasopharyngeal carcinoma - WHO type 3
Must have tumor which is accessible to biopsy
For patients with disease localized to the PNS, the lesion must be visualized by endoscopy
Subjects with metastatic disease with disease accessible to biopsy in the PNS if they are deemed by their treating physicians not to require treatment for at least two weeks.
An ECOG performance status of 0-2
For sexually active women of child-bearing potential, negative pregnancy test within 14 days of enrolling on trial
Must be able to give informed consent
For patients with localized NPC, PNS lesions that cannot be visualized by endoscopy
Patients with disease inaccessible to biopsy
History of anaphylaxis after exposure to valproic acid
Hepatic dysfunction as defined by total bilirubin 1.0x upper limit of normal. AST (SGOT) and ALT (SGPT) 3x upper limit of normal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants