A study looking at how genes may affect the risk of kidney damage in children or young people who have treatment with ifosfamide (PK 2007 02)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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This study is trying to find out if your genetic makeup can affect how much kidney damage you have as a side effect of a drug called ifosfamide.
This trial is for children and young people up to the age of 21. 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
Doctors use a chemotherapy drug called ifosfamide to treat a number of cancers. Unfortunately, kidney damage is quite a common side effect of ifosfamide, but the drug doesn’t affect everybody in this way.
Researchers want to learn more about why some people get kidney problems and some do not. They think that it may be due to differences in our genes.
In this study, the doctors want to look at how much kidney damage children or young people have after treatment with ifosfamide. They will also look at some of their genes to see if there are any differences.
The aim of the study is to find out if there is a link between these genetic variations and the amount of kidney damage. Looking at how genes can affect the way people respond to a drug, or the side effects they have, is called ‘pharmacogenetics’.
You will not get any direct benefit from taking part in this trial. The findings may improve the way doctors use ifosfamide in the future.
Who can enter
You can enter this trial if you
- Have had treatment that included ifosfamide and were under 21 years of age at the time
- Are well enough to have the kidney tests in this trial
You cannot enter this trial if you
- Have had any other type of chemotherapy that can cause kidney damage such as cisplatin, carboplatin, melphalan or high dose methotrexate
- Are currently having treatment that includes ifosfamide
- Have not recovered from any other side effects of earlier chemotherapy
- Have had radiotherapy to the area where the kidneys are
- Have had surgery to remove part or all of a kidney
- Had kidney problems before having ifosfamide
- Have had cancer that spread into the kidneys
- Have kidney damage that the doctors think was mainly caused by other drugs
Trial design
The study will recruit about 300 children and young people in the UK. Everybody taking part will have a blood test. The researchers will look at the DNA in the blood samples to try and find variations in certain genes.
If you have had ifosfamide in the last 5 years, the researchers will also look at how well your kidneys are working now. Some people will already have had this test as part of their follow up care after treatment. If you have already had the test, and the researchers can get the results, they will not do the test again.
If you have not had the test already, the researchers will take an early morning urine sample and 4 small blood samples. This is called a glomerular filtration rate (GFR) test. Between the 1st and 2nd blood sample, they will give you an injection that contains a dye. If you still have a central line in place, the doctors can use this to take the blood samples.
If you had ifosfamide more than 5 years ago, the researchers will try to get the results of any kidney tests done in the first 5 years after treatment. They will not do any more kidney tests at this time.
Hospital visits
If you have the GFR test, there will be one extra hospital visit which lasts about 4 or 5 hours.
Side effects
The dye injection used for the GFR test contains a very small amount of radioactivity. But this is less than the amount from a chest X-ray and will pass out of the body in your urine.
You may have some discomfort or bruising in the area where the blood tests are taken (unless you have a central line that can be used for this).
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Gareth Veal
Supported by
Cancer Research UK
NIHR Clinical Research Network: Cancer
The Newcastle upon Tyne Hospitals NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
