Clinical trial · Interventional
Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies
A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies
NCT00917826CI-TRIAL-00005301terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to assess whether administration of Arginine Butyrate + ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial or complete responses in patients with EBV(+) lymphoid malignancies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV Lymphomas | — | UNRESOLVED | — |
| Lympho-proliferative Diseases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arginine Butyrate | Drug | — | UNRESOLVED |
| Ganciclovir | Drug | — | UNRESOLVED |
| Valganciclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arginine Butyrate + Ganciclovir/Valganciclovir
- interventionNames
- Drug: Arginine Butyrate
- Drug: Ganciclovir
- Drug: Valganciclovir
Primary outcomes (1)
- measure
- Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
- timeFrame
- Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Secondary outcomes (2)
- measure
- Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
- timeFrame
- Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 3 years. (No dosing or adverse event data are currently available on the use of valganciclovir in patients \< 16 years of age.) * Life expectancy of \> 3 months. * ECOG Performance Status 0-2 or Karnofsky Performance Scale ≥ 60%. * Baseline (untransfused) HbF level \> 2% * Normal organ and marrow function defined as: (i) absolute neutrophil count of ≥ 1,000/µL. (ii) platelets ≥ 50,000/ µL. (iii) total bilirubin of ≤ 2.0 x upper limit of normal. (iv) AST (SGOT)/ALT(SGPT) of ≤ 2.0 x institutional upper limit of normal. (v) creatinine within normal range for institution. * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. * Able and willing to give informed consent. Exclusion Criteria: * Patients that have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entry, or those who have not recovered form adverse events due to agents administered 4 weeks earlier. * Patients may not be receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Arginine Butyrate, ganciclovir or valganciclovir. * Patients who have an acute myocardial infarction or onset of atrial fibrillation within the past 6 months. * Uncontrolled intercurrent illness including, but not limited to , ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Tumor impinging on an organ or anatomical structure deemed critical by the investigator. * Pregnant women.
References
Publications (0)
Data not yet available
No reference posted for this study.