A study looking at blood levels of chemotherapy drugs in people with Ewing's sarcoma (PK 2013 01)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Children's cancers

Ewing sarcoma

Sarcoma

Status:

Closed

Phase:

Pilot

This study is looking at what happens to chemotherapy drugs in the body during treatment for Ewing’s sarcoma. The study is supported by Cancer Research UK.

This study is for both adults and children. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

More about this trial

Treatment for Ewing’s sarcoma usually includes chemotherapy. You may have treatment that includes the drugs:

Doctors call this VDC/IE.

We know from research that there are variations in how people get rid of these drugs from their bodies. In this study, researchers are measuring levels of the drugs in the blood after treatment. It is called a pharmacokinetic study.

The main aims of the study are to see

If the blood levels influence the side effects people have and their response to the drugs
How the blood levels vary in people of different ages

Taking part in this study will not affect the treatment you have. The results may improve the way doctors use these chemotherapy drugs in the future.

Who can enter

You may be able to enter this study if you

Have Ewing’s sarcoma and are having VDC/IE chemotherapy as part of your treatment
Have had a tube put into your chest to give drugs directly into one of your major blood vessels (a central line)

You cannot enter the study if

You are having another type of chemotherapy that is not standard treatment
The doctors running the study don’t think it would be right for you to take part

Trial design

The study will recruit 140 people having chemotherapy for Ewing’s sarcoma.

You have chemotherapy in cycles of treatment. If you take part in this study, the study team will take a number of blood samples during 2 cycles of your chemotherapy treatment.

They will take the blood from your central line so you won’t need to have any extra needles.

The study team will also take extra samples to study certain genes that may control how fast the drugs are removed from your body and to see if they can predict which patients may be more likely to have side effects. They will take this sample before you start your 1st cycle of chemotherapy. The researchers want to see if they can work out at an early stage in treatment who is likely to get infections or a sore mouth because of the chemotherapy.