Status:
WITHDRAWN
Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National University Hospital of Singapore
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 ther...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00181220
Start Date
April 1 2004
End Date
September 1 2006
Last Update
May 18 2020
Active Locations (1)
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1
Johns Hopkin Singapore International Medical Center
Singapore, Singapore