Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies
RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of MK0752 in treating
young patients with recurrent or refractory CNS cancer.
OBJECTIVES:
Primary
- To estimate the maximum tolerated dose (MTD) and recommended phase II dose of MK0752
administered for 3 consecutive days of every 7 days in 28 day courses to young patients
with recurrent or refractory CNS malignancies (Dosing regimen 1 - closed to accrual
2/23/2010).
- To estimate the MTD and recommend a phase II dose of MK0752 administered once weekly in
28 day courses to young patients with recurrent or refractory CNS malignancies (Dosing
regimen 2).
- To compared the MK0752 systemic exposure attained with each dosage level on the
different dosing regimens.
Secondary
- To characterize the pharmacokinetics of MK0752.
- To document and describe toxicities associated with MK0752.
- To preliminarily define the antitumor activity of MK0752 within the confines of a phase
I setting.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral MK0752 once daily on days 1-3, 8-10, 15-17, and 22-24 (dosing regimen
1 - closed to accrual 2/23/2010) or days 1, 8, 15, and 22 (dosing regimen 2). Treatment
repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Treatment may be extended up to 19 courses if the patient is
benefitting from the treatment.
Patients undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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