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| Name | Class |
|---|---|
| Boston University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arginine Butyrate + Ganciclovir/Valganciclovir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arginine Butyrate | Drug | 1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle) |
|
| Measure | Description | 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.) |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Lerner, M.D. | Boston University School of Mediciine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| C033018 | arginine butyrate |
| D015774 | Ganciclovir |
| D000077562 | Valganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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|
| Ganciclovir | Drug | 5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle) |
|
| Valganciclovir | Drug | 900 mg BID for 16 days (Days 6-21 of each 21 day cycle) |
|
| 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.) |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |