Lymphoma Clinical Trial
Official title:
A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
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