Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer
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|ClinicalTrials.gov Identifier: NCT00387530|
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 13, 2006
Last Update Posted : February 9, 2009
RATIONALE: The Epstein-Barr virus can cause cancer and lymphoproliferative disorders. Valganciclovir is an antiviral drug that acts against the Epstein-Barr virus. Phenylbutyrate may make cells infected with Epstein-Barr virus more sensitive to valganciclovir. Giving phenylbutyrate together with valganciclovir may block the growth of Epstein-Barr virus-infected cells and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving phenylbutyrate together with valganciclovir works in treating patients with relapsed or refractory Epstein-Barr virus-positive cancer.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Head and Neck Cancer Lymphoma Lymphoproliferative Disorder||Drug: oral sodium phenylbutyrate Drug: valganciclovir Genetic: polymerase chain reaction Genetic: protein expression analysis Procedure: biopsy||Phase 2|
- Determine the rate of Epstein-Barr virus (EBV) lytic phase activation by BZLF1 expression in patients with relapsed or refractory, EBV-positive malignancies treated with phenylbutyrate.
- Determine tumor responses in patients treated with phenylbutyrate followed by valganciclovir.
- Track serum EBV load by quantitative polymerase chain reaction and correlate changes with EBV lytic phase activation/tumor response.
OUTLINE: This is an open-label study.
Patients receive oral phenylbutyrate three times daily on days 1-21 and oral valganciclovir once or twice daily on days 4-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients undergo biopsy on day 3 of course 1. Serum Epstein-Barr virus DNA is analyzed for expression of BZLF1 and LMP2 by quantitative polymerase chain reaction on days 3 and 14 of course 1 and on day 1 of each subsequent course.
After completion of study treatment, patients are followed at 1 and 3 months.
PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors|
|Study Start Date :||May 2006|
|Estimated Primary Completion Date :||January 2008|
- Evidence of Epstein-Barr virus (EBV) lytic phase activation (expression of EBV antigens BZLF1 and LMP2) as assessed by biopsy on day 3 of course 1
- Tumor response in patients with measurable disease as assessed by RECIST criteria
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 ClinicalTrials.gov identifier (NCT number): NCT00387530
|United States, California|
|Rebecca and John Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Study Chair:||William L. Read, MD||University of California, San Diego|