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Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181220
Recruitment Status : Withdrawn (PI left JHU and is not able to be reached for updates)
First Posted : September 16, 2005
Last Update Posted : May 18, 2020
National University Hospital of Singapore
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: valproic acid Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Study Start Date : April 2004
Study Completion Date : September 2006

Primary Outcome Measures :
  1. expression of EBV lytic cycle antigens in NPC tumor tissue. [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Hemoglobin 8g/dl, Absolute neutrophil count 1500 cells/mm, and Platelet count 100,000 /mm
  • Creatinine 3x upper limit of normal
  • PT/PTT blood test result not within normal range
  • Patients who require treatment with an anticonvulsant besides valproic acid during the course of valproate prescribed by the protocol
  • ECOG Performance status 3-4
  • Patients who are pregnant or breast feeding (Sexually active women of childbearing potential must use contraception during course of therapy and within 4 weeks of completion of trial)
  • Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181220

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Johns Hopkin Singapore International Medical Center
Singapore, Singapore
Sponsors and Collaborators
Johns Hopkins University
National University Hospital of Singapore
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Principal Investigator: Wen-son Hsieh, M.D. Johns Hopkins University
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Responsible Party: Johns Hopkins University Identifier: NCT00181220    
Other Study ID Numbers: Valproic Acid NPC
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2019
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs