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

• Status: Withdrawn
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Cancer Institute (NCI)
• Treatments: 4-phenylbutyric acid; Ganciclovir; Valganciclovir

Criteria

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