Leukemia Clinical Trial
Official title:
A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric 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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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