Tipifarnib in Treating Young Patients With Refractory Leukemia
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia|
|Study Start Date:||June 2001|
|Study Completion Date:||March 2005|
- 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.
- 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.
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|Study Chair:||Brigitte C. Widemann, MD||National Cancer Institute (NCI)|