"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at 177 Lutetium DOTATATE for neuroblastoma in children and young people (LuDO)
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
- If LuDO can help children and young people with neuroblastoma
- How safe it is
Who can enter
You may be able to enter this trial if
- Your neuroblastoma has stopped responding to treatment, has come back or got worse after treatment
- You are well enough – if you are over 16 years old this means you cannot take part if you always need help to care for yourself (Karonfsky score of 40 or less) and for children under 16 it means you cannot take part if you are bed most of the time (Lansky score of 40 or less)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 6 months afterwards if you are sexually active
- Your kidneys work well enough – you doctor will test for this
- You are between 18 months and 18 years old
You cannot enter this trial if you
- Are having any other anti cancer treatment
- Have already been treated with a drug similar to LuDO – your doctor can confirm this
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.
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
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 (
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- 2 different types of PET-CT scans
- mIBG scan
- MRI scan or CT scan
- Bone marrow test
- Urine tests
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
- Feeling or being sick (nausea)
- Feeling tired
- Loss of appetite
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
- Hair thinning
- Change to the way your kidneys work
How to join a clinical trial
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.