Clinical trial · Interventional
Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer
A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| oral sodium phenylbutyrate | Drug | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| valganciclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm Study of Biopsy
- interventionNames
- Drug: oral sodium phenylbutyrate
- Drug: valganciclovir
- Genetic: polymerase chain reaction
- Genetic: protein expression analysis
- Procedure: biopsy
Primary outcomes (1)
- measure
- 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)
- measure
- Tumor response in patients with measurable disease as assessed by RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 patientsReferences
Publications (0)
Data not yet available