This trial is active, not recruiting.

Conditions gastric cancer, head and neck cancer, lymphoma, lymphoproliferative disorder
Treatments oral sodium phenylbutyrate, valganciclovir, polymerase chain reaction, protein expression analysis, biopsy
Phase phase 2
Sponsor University of California, San Diego
Collaborator National Cancer Institute (NCI)
Start date May 2006
End date January 2008
Trial size 14 participants
Trial identifier NCT00387530, CDR0000504022, ROCHE-VAL-108, UCSD-050126


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

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
time frame:

Secondary Outcomes

Tumor response in patients with measurable disease as assessed by RECIST criteria
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - 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 disease - 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 PATIENT CHARACTERISTICS: - 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 participation PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Concurrent cerebrospinal fluid drugs allowed - No concurrent zidovudine for HIV-positive patients

Additional Information

Official title A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).