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Therapeutic Areas: Oncology | Family Medicine
Disease Category: Solid Tumors
Location: United States, OH
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
- To determine whether Sunitinib is a beneficial treatment for
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
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.,
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
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
If you would like to learn more about participating in this study, please send an email message using the form below.
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