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

Phase 2

Withdrawn

• Conditions: Gastric Cancer; Head and Neck Cancer; Lymphoma; Lymphoproliferative Disorder
• Interventions: Drug: oral sodium phenylbutyrate; Drug: valganciclovir; Genetic: polymerase chain reaction; Genetic: protein expression analysis; Procedure: biopsy

• Registration Number: NCT00387530
• Lead Sponsor: University of California, San Diego

Brief 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study of Biopsy	oral sodium phenylbutyrate	-
Single Arm Study of Biopsy	polymerase chain reaction	-
Single Arm Study of Biopsy	protein expression analysis	-
Single Arm Study of Biopsy	biopsy	-
Single Arm Study of Biopsy	valganciclovir	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Tumor response in patients with measurable disease as assessed by RECIST criteria

Trial Locations

Locations (1)

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States