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

Phase 2
18 Years
Open (Enrolling)
Gastric Cancer, Head and Neck Cancer, Lymphoma, Lymphoproliferative Disorder

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Trial Information

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
with phenylbutyrate.


- 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.

Inclusion Criteria


- Biopsy-proven Epstein-Barr virus (EBV)-positive malignancy

- Must have tissue analysis to confirm EBV positivity

- Archival tissue ≤ 1 year old may be used

- Any of the following malignancies:

- WHO type II or III nasopharyngeal carcinoma

- Post-transplant lymphoproliferative disorder

- Nasal NK/T-cell lymphoma

- Hodgkin's lymphoma

- Lymphoepithelioma-variant gastric carcinoma

- AIDS-related lymphomas

- Patients with CNS non-Hodgkin's lymphoma must have tumor cells present in
the cerebrospinal fluid (and assessable with lumbar puncture)

- Relapsed or refractory disease

- Must have received and failed all prior potentially curative treatment for

- Eligible only for salvage therapy

- Must have tumor tissue amenable for minimally invasive biopsy (e.g., fine-needle
aspiration or bone marrow biopsy)

- No brain tumors not amenable to biopsy

- CNS metastases allowed provided ≥ 2 weeks since prior radiotherapy


- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Absolute granulocyte count ≥ 500/mm³

- Platelet count ≥ 50,000/mm³

- Bilirubin ≤ 1.5 times upper limit of normal

- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min

- Recovered from uncontrolled intercurrent illness, including, but not limited to, any
of the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Able to take medication orally or by gastrostomy tube

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to, during, and for 90 days
after completion of study treatment

- No uncontrolled grade 1 symptomatic diarrhea (i.e., > 3 stools/day)

- No concurrent serious medical or psychiatric illness that would preclude study


- See Disease Characteristics

- Concurrent cerebrospinal fluid drugs allowed

- No concurrent zidovudine for HIV-positive patients

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

William L. Read, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Diego


United States: Federal Government

Study ID:




Start Date:

May 2006

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Head and Neck Cancer
  • Lymphoma
  • Lymphoproliferative Disorder
  • recurrent lymphoepithelioma of the nasopharynx
  • post-transplant lymphoproliferative disorder
  • adult nasal type extranodal NK/T-cell lymphoma
  • recurrent adult Hodgkin lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • recurrent gastric cancer
  • Head and Neck Neoplasms
  • Lymphoma
  • Lymphoproliferative Disorders
  • Stomach Neoplasms



Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658