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Therapeutic Areas: Oncology
Disease Category: Solid Tumors

Trial Information

ADVL0612: A Phase I Study of Sunitinib (SU11248), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Children with Refractory Solid Tumors

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

• To find the highest safe dose of Sunitinib that can be given without causing severe side effects
• To learn what kind of side effects Sunitinib can cause
• To learn more about the pharmacology (how the body handles the drug) of Sunitinib
• To learn about the effects of Sunitinib on cells and proteins in the blood
• To assess the effect of Sunitinib on blood flow in tumors by using MRI
• To determine whether Sunitinib is a beneficial treatment for tumors

Who will be included in this study?
Patients with recurrent or progressive solid tumors (except brain tumors) and who are = 2 years and = 21 years old are eligible to participate in this clinical trial.

What is involved?
Patients who do not have serious side effects and whose tumor is not getting worse may continue to get Sunitinib for up to 12 months.

Before patients can participate in this study, they will take part in a screening process to see if he/she is eligible. This screening process will include:

• A medical history
• Physical exam
• Vital signs (blood pressure, pulse, temperature)
• Blood tests
• Pregnancy test (for a women who could have children)
• ECHO and EKG (test of heart function)
• Plain X-rays of the knees
• Other tests or scans that are needed to check the tumor (e.g., CT scans)

Sunitinib will be given orally once daily for 28 days, then there will be a 14-day rest period.

These following tests and procedures are all necessary to make sure patients are not having unsafe side effects and to see whether or not the patient’s tumor is responding to Sunitinib.

• Physical exam
• Blood tests
• Pregnancy test
• ECHO and EKG
• Plain X-ray
• CT scan and/or MRI of the tumor

What are the benefits?
Patients may receive no direct benefit from participating in this study. The potential benefit is that sunitinib may cause cancer to stop growing or go into partial remission for a period of time or it may lessen symptoms. The knowledge gained from this study may be helpful to other children. Clinical trials are essential in finding new and improved treatments.

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 them and will be sure that all of their 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/guardians interested in knowing more about the study.

For more information,

Rebecca Turner, MS, CCRP
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Division of Hematology/Oncology
3333 Burnet Ave
Cincinnati, OH 45229-3039
Phone: 513-636-2279
EMail: cancer@cchmc.org

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