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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Withdrawn
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
valproic acid
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkin Singapore International Medical Center

Outcomes

Primary Outcome Measures

expression of EBV lytic cycle antigens in NPC tumor tissue.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
May 14, 2020
Sponsor
Johns Hopkins University
Collaborators
National University Hospital of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00181220
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI left JHU and is not able to be reached for updates
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National University Hospital of Singapore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
valproic acid
Primary Outcome Measure Information:
Title
expression of EBV lytic cycle antigens in NPC tumor tissue.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-son Hsieh, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkin Singapore International Medical Center
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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