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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181220
First received: September 13, 2005
Last updated: August 21, 2006
Last verified: September 2005
  Purpose

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 Intervention Phase
Nasopharyngeal Carcinoma
Drug: valproic acid
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • expression of EBV lytic cycle antigens in NPC tumor tissue.

Estimated Enrollment: 20
Study Start Date: April 2004
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181220

Contacts
Contact: Wen-son Hsieh, M.D. (65) 68747745 hsiehwe@bms.jhmi.edu

Locations
Singapore
Johns Hopkin Singapore International Medical Center Recruiting
Singapore, Singapore
Contact: Wen-son Hsieh, M.D.    (65)68747745    hsiehwe@bms.jhmi.edu   
Principal Investigator: Wen-son Hsieh, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Wen-son Hsieh, M.D. Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181220     History of Changes
Other Study ID Numbers: Valproic Acid NPC
Study First Received: September 13, 2005
Last Updated: August 21, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014