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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States
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