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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle)
900 mg BID for 16 days (Days 6-21 of each 21 day cycle)
Hackensack University Medical Center
Hackensack, New Jersey, United States
Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Time frame: 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.)
Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Time frame: 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
Time frame: 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.)
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