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

NCT00387530 | Withdrawn Phase 2 DMC

• 3 other identifiers: UCSD-050126CDR0000504022ROCHE-VAL-108
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; Head and Neck Cancer; Lymphoma; Lymphoproliferative Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Tumor response in patients with measurable disease as assessed by RECIST criteria

Study Arms (1)

Single Arm Study of Biopsy

OTHER

Drug: oral sodium phenylbutyrate; Drug: valganciclovir; Genetic: polymerase chain reaction; Genetic: protein expression analysis; Procedure: biopsy

Interventions

oral sodium phenylbutyrate DRUG

Single Arm Study of Biopsy

valganciclovir DRUG

Single Arm Study of Biopsy

polymerase chain reaction GENETIC

Single Arm Study of Biopsy

protein expression analysis GENETIC

Single Arm Study of Biopsy

biopsy PROCEDURE

Single Arm Study of Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Head and Neck Neoplasms; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Extranodal NK-T-Cell; Hodgkin Disease

Interventions

4-phenylbutyric acid; Valganciclovir; Polymerase Chain Reaction; Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• William L. Read, MD

  University of California, San Diego

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

US (1)