MK0752 in Treating Young Patients With Recurrent or Refractory CNS Cancer
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00572182
- Lead Sponsor
- Pediatric Brain Tumor Consortium
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Maximum tolerated dose First 28 days of treatment MK0752 systemic exposure Day 1 of course 1 Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Day 1 of course 1 Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.
Toxicity From day 1 of treatment until off study Objective response rate End of courses 2, 4, 6 and at the end of treatment Brain imaging to assess tumor response to the treatment is performed at baseline, at the end of courses 2, 4, 6 and at the end of therapy.
Trial Locations
- Locations (12)
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
NCI - Pediatric Oncology Branch
🇺🇸Bethesda, Maryland, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Dan L. Duncan Cancer Center at Baylor College of Medicine
🇺🇸Houston, Texas, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States