Clinical Research Study Viewer

Phase I, Traditional 3+3, Trial of PO Sorafenib and Topotecan in Refractory or Recurrent Pediatric Solid Malignancies

Why are we doing this study?

The purpose of this research study is to establish a dose of the combination of study drugs, Topotecan and Sorafenib in children.  This will be called the maximum tolerated dose.  We are trying to find the highest dose of each study drug that can be safely given to children with refractory or recurrent pediatric solid malignancies.  We will do this by testing different doses of these drugs in different groups of children.  We will also study how the body processes these drugs.

 

Who can participate in this study?

We are looking for children and adolescents who are between the ages of 3 and 18 years old who have had relapsed or refractory solid tumor malignancy, or a relapsed or refractory central nervous system malignancy and have received at least one prior course of therapy. There are some other requirements your child must meet to protect his/her safety. If you are interested in taking part in this study, the study team will discuss this with you and your child.

 

What will happen during this study?

If you and your child agree to be part of this research, your child will have some tests done to make sure that is okay for your child to be in this study.

 

Your child will receive the treatment in cycles.  Every cycle is 28 days long.  For the first cycle your child will get the chemotherapy drugs Topotecan and Sorafenib on a fixed schedule. These medications are taken by mouth (PO).

 

A course may be repeated every 28 days if your child has at least stable disease and any side effects he/she experiences are not severe.  The dose of Sorafenib and Topotecan will be determined by how many other children have gone on the study before your child and how well they tolerated it. During treatment, your child will have exams and tests done to monitor his/her health at regularly scheduled time points. This will include blood draws and imaging tests (MRI, CT, and/or x-ray).

 

Is this risky or painful?

Right now, we do not know for sure if the study drugs will help.  If they do not help, your child’s disease may get worse.

 

You/your child may experience side effects from taking the medicines involved in this study. Some side effects are just bothersome while others could cause harm.  All people who receive cancer treatment are at risk of having side effects. Common side effects of chemotherapy include nausea, vomiting, and hair loss. Chemotherapy may also decrease the number of blood cells which may result in fatigue, increased chance of infection, and increased chance of bleeding. Some infections may be serious and require hospitalization. Your study doctor will review all risks and side effects related to each study drug with you prior to beginning the study. All study patients will be monitored closely for side effects and potential health problems.

 

The procedures and tests done during this study also carry some additional risks. The study team will explain these to you prior beginning the study and before each procedure is done.

 

What are the benefits?

We do not know if your child will directly benefit from being in this study. We hope the information we gain from this study will help other patients in the future.

 

Where can I get more information?

More information about this study can be found on ClinicalTrials.gov:  https://www.clinicaltrials.gov/ct2/show/NCT01683149

 

For more details, please contact Dr. Bhuvana Setty at 614-722-3553, Bhuvana.Setty@nationwidechildrens.org or Amy Yekisa at 614-722-6570, amy.yekisa@nationwidechildrens.org.

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000