NCT00387530

Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer

A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Cancer
• Head and Neck Cancer
• Lymphoma
• Lymphoproliferative Disorder

Interventions

Type	Name	Description
DRUG	oral sodium phenylbutyrate
DRUG	valganciclovir
GENETIC	polymerase chain reaction
GENETIC	protein expression analysis
PROCEDURE	biopsy

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-10-13
• Last updated: 2019-08-02

Locations

1 site across 1 country: United States