Trial Information

PBTC-024: A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies

What is the purpose of this study?
The goals of this research study are:

To find the highest dose of MK-0752 that can be given without causing severe side effects
To learn what side effects may occur when MK-0752 is given
To learn how the body processes MK-0752 by studying the levels of the drug in the blood
To learn more from blood tests that may help us to understand how the drug is working and to see if changes in those tests are related to how the tumor responds to MK-0752
To learn how certain tumors respond to MK-0752 by studying the characteristics of these tumors in a laboratory

Who will be included in this study?
Patients under the age of 12 years who have a primary CNS brain tumor that is growing or has come back (recurred) may be eligible to participate in this study.

What is involved?
Before patients can participate in this study, they will take part in a screening process that will include:

A medical history
A physical examination
Vital signs
Neurological exam
Blood tests
A pregnancy test for females of childbearing potential
Scans of the brain (MRI)
Scans of the spine (MRI), if the doctor finds it necessary
A spinal tap (lumbar puncture) to see if there are cancer cells in the spinal fluid, if the doctor finds it necessary

The following tests are all necessary to make sure that patients are not having unsafe side effects of MK-0752.

A physical examination with vital signs
A neurological exam
Scans of the brain (MRI)
Scans of the spine (MRI), if the doctor finds it necessary
A spinal tap (lumbar puncture) to see if there are cancer cells in the spinal fluid, if the doctor finds it necessary

What are the benefits?
Taking part in this study may or may not make the patient’s health better. While doctors hope MK-0752 will be more useful against cancer compared to the standard treatment, there is no proof of this yet. The potential benefit from treatment in this study is that the MK-0752 may cause the cancer to stop growing, shrink for a period of time, or lessen the symptoms associated with the tumor. Information from this study will help doctors learn more about how MK-0752 affect brain tumors and that information could help future cancer patients.

Will I get all the facts about the study?
Patients or parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until the patient/parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects can be provided to those patients interested in knowing more about the study.

Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Division of Hematology/Oncology, MLC 11027
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Phone: 513-636-2799
Email: cancer@cchmc.org

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Research Center Information: Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation

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