Gastric CancerPhase 2NCT00387530
Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer
A Phase 2 study testing oral sodium phenylbutyrate, valganciclovir and polymerase chain reaction in people with Gastric Cancer and Head and Neck Cancer, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Head and Neck Cancer, Lymphoma
- What is being tested?
- oral sodium phenylbutyrate, valganciclovir and polymerase chain reaction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
About this study
Official title: A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors
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.
Read the detailed description
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.
- Being tested
- oral sodium phenylbutyrate, valganciclovir, polymerase chain reaction, protein expression analysis, biopsy
- 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
- Medical subject headings
- Stomach Neoplasms, Head and Neck Neoplasms, Lymphoma, Lymphoproliferative Disorders, Lymphoma, Extranodal NK-T-Cell, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral sodium phenylbutyrateDrug
valganciclovirDrug
polymerase chain reactionGenetic
protein expression analysisGenetic
biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study of Biopsy | Other | Not described Receives: Drug: oral sodium phenylbutyrate; Drug: valganciclovir; Genetic: polymerase chain reaction; Genetic: protein expression analysis; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William L. Read, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387530
- Sponsor's protocol ID
- UCSD-050126
- Other IDs
- CDR0000504022, ROCHE-VAL-108
- Status last verified
- Jul 2019
- First submitted
- 12 Oct 2006
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors
- ClinicalTrials.gov ID
- NCT00387530
- Acronym / sponsor ID
- UCSD-050126
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study of Biopsy | Other | Drug: oral sodium phenylbutyrate, Drug: valganciclovir, Genetic: polymerase chain reaction, Genetic: protein expression analysis, Procedure: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Single Arm Study of Biopsy |
Primary outcome
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
1 secondary outcome
Tumor response in patients with measurable disease as assessed by RECIST criteria
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William L. Read, MD study chair
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral sodium phenylbutyrate, valganciclovir and polymerase chain reaction in people with Gastric Cancer and Head and Neck Cancer, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.