Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer
NCT ID: NCT00387530
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2006-05-31
2008-01-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm Study of Biopsy
oral sodium phenylbutyrate
valganciclovir
polymerase chain reaction
protein expression analysis
biopsy
Interventions
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oral sodium phenylbutyrate
valganciclovir
polymerase chain reaction
protein expression analysis
biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Diego
OTHER
Responsible Party
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Principal Investigators
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William L. Read, MD
Role: STUDY_CHAIR
University of California, San Diego
Locations
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Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Countries
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Other Identifiers
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CDR0000504022
Identifier Type: REGISTRY
Identifier Source: secondary_id
ROCHE-VAL-108
Identifier Type: -
Identifier Source: secondary_id
UCSD-050126
Identifier Type: -
Identifier Source: org_study_id
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