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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
expression of EBV lytic cycle antigens in NPC tumor tissue.
Condition
Nasopharyngeal Carcinoma
Intervention
valproic acid
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
April 2004
Completion Date
September 2006
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Wen-son Hsieh, M.D., ,
Location Countries
Singapore
Location Countries
Singapore
Administrative Informations
NCT ID
NCT00181220
Organization ID
Valproic Acid NPC
Responsible Party
Sponsor
Study Sponsor
Johns Hopkins University
Collaborators
National University Hospital of Singapore
Study Sponsor
Wen-son Hsieh, M.D., Principal Investigator, Johns Hopkins University
Verification Date
May 2019