Finding studies
Finding studies
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Lead
National Institutes of Health Clinical Center (CC)
With
OBJECTIVES: Primary * Determine the maximum tolerated dose and toxicity profile of tipifarnib in pediatric patients with refractory leukemia. * Determine the pharmacokinetics of this drug in these patients. * Determine the toxicity profile of this drug in these patients. Secondary * Analyze the gene expression profile of leukemic blasts from these patients before and after treatment with this drug. * Determine circulating levels of nerve growth factor and correlate these levels with clinical neurotoxicity from this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. At least 9 additional patients are treated at the MTD. PROJECTED ACCRUAL: A total of 12-34 patients will be accrued for this study within 1-2 years.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
