Finding studies
Finding studies
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Lead
Dana-Farber Cancer Institute
With
OBJECTIVES: * Determine complete response rate in post-hematopoietic stem cell transplant patients with severe veno-occlusive disease of the liver treated with defibrotide. * Determine the minimal effective dose of this drug in these patients. * Assess toxicity and adverse side effects of this drug in these patients. OUTLINE: This is a randomized, multicenter study. All patients initially receive the same dose of defibrotide IV over 2 hours every 6 hours on day 1. On day 2, patients are randomized to 1 of 2 doses of defibrotide. * Arm I: On days 2-14, patients receive a lower dose of defibrotide IV over 2 hours every 6 hours. * Arm II: On days 2-14, patients receive a higher dose of defibrotide IV over 2 hours every 6 hours. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 140 patients (70 per treatment arm) will be accrued for this study.
Age
0–18
Sex
ALL
Healthy volunteers
Not accepted
