Leukemia Clinical Trial
Official title:
A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in
treating young patients with refractory or recurrent leukemia.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of temozolomide in
pediatric patients with refractory or recurrent leukemia.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine the antitumor activity of this drug in these patients.
- Determine the biologic activity and mechanism(s) of resistance to this drug in these
patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days
for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18-24
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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