MK0752 in Treating Young Patients With Recurrent or Refractory CNS Cancer
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies|
- Maximum tolerated dose [ Time Frame: First 28 days of treatment ] [ Designated as safety issue: Yes ]
- MK0752 systemic exposure [ Time Frame: Day 1 of course 1 ] [ Designated as safety issue: No ]Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.
- Pharmacokinetics [ Time Frame: Day 1 of course 1 ] [ Designated as safety issue: No ]Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.
- Toxicity [ Time Frame: From day 1 of treatment until off study ] [ Designated as safety issue: Yes ]
- Objective response rate [ Time Frame: End of courses 2, 4, 6 and at the end of treatment ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Maryland|
|NCI - Pediatric Oncology Branch|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|Dan L. Duncan Cancer Center at Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Study Chair:||Maryam Fouladi, MD||Children's Hospital Medical Center, Cincinnati|