Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer
Recruitment status was: Active, not recruiting
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.
Head and Neck Cancer
Drug: oral sodium phenylbutyrate
Genetic: polymerase chain reaction
Genetic: protein expression analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors|
- 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 [ Designated as safety issue: No ]
- Tumor response in patients with measurable disease as assessed by RECIST criteria [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Estimated Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|