NCT00572182

MK0752 in Treating Young Patients With Recurrent or Refractory CNS Cancer

A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Pediatric Brain Tumor Consortium · Network
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	MK-0752	This is a dose escalation study. Patients may receive 150, 200, 260 or 325 mg/m2 orally for 3 consecutive days of every 7 days for 28 days (dosing regimen 1 - closed to accrual 2/23/2010) or 800, 1000, 1400, or 1800 mg/m2 orally once weekly for 28 days (1 course). In the absence of unacceptable toxicity or disease progression, treatment may continue for 6 courses.

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2007-12-12
• Last updated: 2012-03-06

Locations

12 sites across 1 country: United States