A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies
- 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
- 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
- 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
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
Maximum tolerated dose
First 28 days of treatment
Maryam Fouladi, MD
Children's Hospital Medical Center, Cincinnati
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15213|
|Children's Memorial Hospital - Chicago||Chicago, Illinois 60614|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|NCI - Pediatric Oncology Branch||Bethesda, Maryland|
|Dan L. Duncan Cancer Center at Baylor College of Medicine||Houston, Texas 77030|
|Seattle Children's Hospital||Seattle, Washington 98105|