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A trial looking at 177 Lutetium DOTATATE for neuroblastoma in children and young people (LuDO)
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Please note – this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called 177 Lutetium DOTATATE (LuDO) for children and young people with neuroblastoma. This trial is supported by Cancer Research UK.
This trial is for children and young people up to the age of 18. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.
Neuroblastoma develops in specialised nerve cells and most commonly starts in the nerve cells of the adrenal glands. Doctors can use different treatments for neuroblastoma including surgery, chemotherapy, radiotherapy and stem cell transplant.
But even if neuroblastoma has responded well to treatment, it may still come back later, and if so, it can be difficult to treat successfully. Doctors are looking for new ways to treat neuroblastoma and stop it coming back.
Many neuroblastomas have a particular protein on their cells called somatostatin. Researchers think they can use these proteins to deliver a dose of radiotherapy to the neuroblastoma.
Drugs called somatostatin analogues can target somatostatin on the surface of neuroblastoma cells. LuDO is a somatostatin analogue that has a radioactive molecule attached to it. LuDO finds the neuroblastoma cells and then the radioactivity kills them.
We know from other clinical trials that this type of treatment can help people with other types of cancer.
The aims of this trial are to find out
You may be able to enter this trial if
You cannot enter this trial if you
This is a phase 2 trial. To start with, it will recruit 14 children and young people. If 3 or more respond to treatment, the team will recruit another 10 to make a total of 24 children and young people in the trial.
Everyone taking part will have LuDO. This is a liquid you have as an injection into one of your large veins. You have it through your central line or portacath.
You have LuDo once every 8 to 14 weeks. This is called a cycle of treatment. You have 3 scans during the week after having LuDO. This is to see what it is doing in your body.
You can have up to 4 cycles of LuDO, as long as it is helping you and the side effects aren’t too bad.
LuDO is a radioactive injection
. It gives off high energy rays. For this reason you will stay in a specially protected room at the hospital away from other people while you have treatment and for at least 3 days afterwards. Your mother, father, or someone else you choose, will be able to stay with you in your room for as long as you want during this time.
Before having LuDO you have another liquid through your central line or portacath. This is to protect your kidneys and to give you some anti sickness medication.
If you agree to take part in this study, the researchers will ask for a small piece of tissue taken when you had surgery to remove your cancer, or a sample of tissue (biopsy). If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor regularly to have blood tests and to see how you are. You have scans at 1 month, 4 months, 7 months and then every 6 months.
After treatment you see the doctor for tests and to see how you are at 1 month, 4 months and then every 6 months for 5 years.
The most common side effects of LuDO include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Mark Gaze
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
This is Cancer Research UK trial number CRUK/11/031.
Freephone 0808 800 4040
Email
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at 177 Lutetium DOTATATE for neuroblastoma in children and young people (LuDO)
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