RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.
OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with recurrent Philadelphia chromosome-positive leukemia. * Characterize the pharmacokinetic behavior of this drug in this patient population. * Determine preliminarily the antileukemic activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral imatinib mesylate (STI571) once daily for 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study within 3.5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Survival
To estimate the maximum tolerated dose (MTD) of STI571 administered orally once daily without interruption to children with recurrent Ph+ leukemia.
Time frame: Length of study
Dose-limiting toxicities
To determine the dose-limiting toxicities (DLT) of STI571 given on this schedule.
Time frame: Length of study
Characterize the pharmacokinetic behavior
To characterize the pharmacokinetic behavior of STI571 in children with recurrent Ph+ leukemia.
Time frame: Length of study
Define the anti-leukemic activity of STI571
To preliminarily define the anti-leukemic activity of STI571 within the confines of a Phase I study.
Time frame: Length of study
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