Status:
WITHDRAWN
Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastric Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 infect...
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 phenyl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00387530
Start Date
May 1 2006
End Date
January 1 2008
Last Update
August 2 2019
Active Locations (1)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658