EBV Lymphomas, Lympho-proliferative Diseases
Conditions
Brief summary
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.
Interventions
1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
DRUGGanciclovir
5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle)
DRUGValganciclovir
900 mg BID for 16 days (Days 6-21 of each 21 day cycle)
Sponsors
Boston University
HemaQuest Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007) | 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
| Measure | Time frame |
|---|---|
| Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007) | 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.) |
| Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam | Up to three 21-day cycles. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessments may continue after treatment is discontinued.) |
Countries
United States
Outcome results
None listed