A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors
- Determine the rate of Epstein-Barr virus (EBV) lytic phase activation by BZLF1
expression in patients with relapsed or refractory, EBV-positive malignancies treated
- Determine tumor responses in patients treated with phenylbutyrate followed by
- 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.
Masking: Open Label, Primary Purpose: Treatment
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
William L. Read, MD
University of California, San Diego
United States: Federal Government
|Rebecca and John Moores UCSD Cancer Center||La Jolla, California 92093-0658|