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Therapeutic Areas: Oncology
Disease Category: Solid Tumors

Trial Information

(ADVL0812) A Phase I Study of MLN8237, an Oral Selective Small Molecule Inhibitor of Aurora A Kinase, in Children with Relapsed/Refractory Solid Tumors and Leukemia

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

• To find the highest safe dose of MLN8237 that can be given without causing severe side effects
• To learn what kind of side effects MLN8237 can cause
• To learn more about the pharmacology (how your body handles the drug) of MLN8237
• To learn more about the biology of MLN8237 (to learn if gene differences affect the way MLN8237 interacts with cancer cells)
• To determine whether MLN8237 is a beneficial treatment for your tumor

Who will be included in this study?
Patients who are greater than 12 months and less than 21 years who have a recurrent or progressive tumor or leukemia that cannot be cured by any known standard treatment may be eligible for this study.

What is involved?
Before you begin the study…
You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.

• A medical history
• Physical exam
• Vital signs (blood pressure, pulse, temperature)
• Blood tests
• Urine tests
• Pregnancy test (if you are a female who could have children)
• We will also do whatever X-rays, CT scans, or other tests are needed to check your tumor

During the study…
If the exams, tests and procedures show that you can be in the study, and you choose to take part, MLN8237 will be given orally once a day for 7 days with a 14-day rest period. This entire 3-week (21 day) period is called a course. You may continue to receive MLN8237 for up to 2 years unless you develop serious side effects or your tumor worsens.

You will also have the following tests and procedures done during the study. They are part of regular cancer care. They are being done more often because you are in this study.

• Physical exam
• Blood tests
• Urine tests
• Scans of your tumor (CT or MRI scans, MIBG scans)
• Bone marrow aspirates or biopsies (if you have neuroblastoma, leukemia, or another solid tumor with bone marrow disease)

These tests are all necessary to make sure that you are not having unsafe side effects and to see whether or not your tumor is responding to MLN8237.

Copies of the scans used to check your disease status may be sent to central review centers as part of COG quality control.

You will be given a Patient Diary at the beginning of each course of MLN8237. You will need to use the diary to record the date and time you take the drug, side effects you experience and other medications you are taking. This diary should be returned to clinic, along with the medication bottle (even if it is empty) each time you have a clinic visit. This will help us to know how much of the drug you take and how it made you feel.

The MLN8237 will be given as a capsule by mouth. The drug should be taken on an empty stomach, which means nothing to eat one hour before and after the medicine is swallowed. Since we do not have information on how well the medicine is absorbed, if you vomit the medication it should not be taken again. Since this medicine can make you sleepy, you can take this medicine at bedtime.

We would also like to do some extra tests called pharmacokinetic studies and biologic studies. These tests will help us learn more about MLN8237 and may help children who receive this drug in the future. The information learned would not change the way you are treated, and the results of these tests will not be returned to you. Some of the pharmacokinetic studies are required to participate in this study and some are optional. The biology studies are all optional. You do not have to do these tests if you do not want to.

What are the benefits?
The potential benefit of the treatment with MLN8237 is that it may cause your cancer to stop growing or to shrink for a period of time. It may lessen the symptoms, such as pain, that are caused by the cancer. Because there is not much information about the MLN8237 effect on cancers in humans, we do not know if you will benefit from taking part in this study. Information learned from this study may help future patients with cancer.

Will I get all the facts about the study?
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 a 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.

Who should I contact for more information?
Rebecca Turner, MS, CCRP
Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology, MLC 11027
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org

Rebecca Turner
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Cincinnati Children’s Hospital Medical Center
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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