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Therapeutic Areas: Oncology
Disease Category: Solid Tumors

Trial Information

(ADVL0714) A Phase I Study of VEGF Trap in Children with Refractory Solid Tumors

What is the purpose of this study?
Researchers are testing new experimental drugs such as VEGF Trap in the hope of finding a drug that may be effective against recurrent tumors. The purpose of this study is to test the safety of VEGF trap to see what effects (good and bad) it has on you and your tumor(s). VEGF Trap is considered experimental because it has not been approved by the Food and Drug Administration (FDA). This is called a Phase I study because the goal is to find the highest dose of VEGF Trap that we can give safely. We are using VEGF Trap because it seems to work against cancer in test tubes and animals. Although VEGF Trap has been used in adults, no studies have been performed in children and there is a lot that we do not know about it yet.
The goals of this research study are:

• To find the highest safe dose of VEGF Trap that can be given without causing severe side effects
• To learn what kind of side effects VEGF Trap can cause
• To learn more about the pharmacology (how your body handles the drug) of VEGF Trap
• To learn about the effects of VEGF Trap on cells and proteins in your blood
• To assess the effect of VEGF Trap on blood flow in your tumor
• To determine whether VEGF Trap 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 of age who have a recurrent tumor (meaning it comes back) or progressive tumor (meaning it gets worse) that cannot be cured by any known standard treatment are eligible to participate in this clinical trial.

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 woman who could have children)
• Plain X-ray of your lower legs
• Tests of hormone function in females

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 if you choose to take part, VEGF Trap will be given as an intravenous infusion. This study is done in two parts.

If you are in Part A of the study, VEGF Trap will be given once every 2 weeks. This entire 2 week period is called a cycle.

If you are in Part B of the study, VEGF Trap will be given once every 3 weeks. For Part B, the entire 3 week period is called a cycle.

You may continue to receive VEGF Trap for 24 months unless you develop serious side effects or your tumor worsens.

What are the benefits?
There may be no direct benefit for you if you agree to take part in this research study. It is unlikely that you will experience significant benefit or cure from the drug VEGF Trap. The potential benefit is that VEGF Trap may cause your cancer to stop growing or go into partial remission for a period of time or it may lessen symptoms. Because there is not much information about the effects of VEGF Trap on cancer in humans, we do not know if you will benefit from taking part in this study. The knowledge gained from this study may benefit others. Your disease may continue to become worse despite taking this drug.

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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