Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer Head and Neck Cancer Lymphoma Lymphoproliferative Disorder |
Drug: oral sodium phenylbutyrate Drug: valganciclovir Genetic: polymerase chain reaction Genetic: protein expression analysis Procedure: biopsy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors |
- 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 [ Designated as safety issue: No ]
- Tumor response in patients with measurable disease as assessed by RECIST criteria [ Designated as safety issue: No ]
| Estimated Enrollment: | 14 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Study Chair: | William L. Read, MD | University of California, San Diego |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00387530 History of Changes |
| Other Study ID Numbers: | CDR0000504022, UCSD-050126, ROCHE-VAL-108 |
| Study First Received: | October 12, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
4-phenylbutyric acid Head and Neck Neoplasms Lymphoma Lymphoproliferative Disorders Stomach Neoplasms Neoplasms by Site Neoplasms Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Valganciclovir Ganciclovir Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 17, 2013