"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study of mIBG, nivolumab and dinutuximab beta for neuroblastoma (MiNivAN)
Cancer type:
Children's cancers
Neuroblastoma
Status:
Open
Phase:
Phase 1
This study is looking at combining mIBG, nivolumab and dinutuximab beta to treat neuroblastoma that has continued to grow during treatment or came back after treatment.
This study is mainly for children and young people. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.
More about this trial
For some children and young people their neuroblastoma is cured by the first treatment they have.
But for others their neuroblastoma continues to grow during treatment or comes back after it. Researchers are looking for new ways to treat these children and young people.
In this study they are looking at 3 treatments.
mIBG is already used as a treatment for neuroblastoma. It is a type of radiotherapy 
. Radioactive iodine is attached to the contrast medium mIBG. Neuroblastoma cells take up the mIBG treatment wherever they are in the body. The radioactive iodine then kills the neuroblastoma cells.
. Radioactive iodine is attached to the mIBG. Neuroblastoma cells take up the mIBG treatment wherever they are in the body. The radioactive iodine then kills the neuroblastoma cells. Nivolumab is an immunotherapy. It works by stimulating the body’s immune system to fight cancer.
Dinutuximab beta is a targeted cancer drug called a monoclonal antibody. It works by targeting a protein called G2 that is found on neuroblastoma cells. Dinutuximab beta is already a treatment for neuroblastoma that is at a high risk of coming back after treatment.
In this study the researchers are looking at combining these 3 treatments.
The main aim of this study is to find out:
- how well this combination works
- how well accepted the treatment is
- what the side effects are
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply.
- You have a neuroblastoma that is at a high risk of coming back after treatment or has come back after treatment
- You have had a scan in the past 4 weeks that shows your neuroblastoma takes up the
contrast medium mIBG - You have a central line in place or are willing to have one put in
- If you at an age where you can mostly take care of yourself but need help from time to time (Karnofsky performance score of 60 or more) or if you are younger, you are up and about but active play is at a minimum and you keep busy mostly with quiet activities (Lansky performance sore of 60 or more)
- You have satisfactory blood test results
- Your heart and lungs work well enough
- You and your parents or carers must be willing and able to follow the safety measures for mIBG treatment
- Your doctor thinks you are able to cope with being in isolation while having mIBG treatment
- There are enough of your
stem cells stored and available to use if needed - If you are at an age where you are sexually active you must be willing to use reliable contraception during treatment and for 7 months after if there is any chance you or your partner could become pregnant
- You are at least 1 year old
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
- You have neuroblastoma that has spread to certain parts of the brain and that takes up the contrast medium mIBG
- You have neuroblastoma that has spread to the brain or spinal cord unless it has been treated and is stable at least 4 weeks before starting treatment
- You have neuroblastoma that has spread to your skull bone and is causing swelling of the brain
- You have had
high dose chemotherapy and stem cell transplant less than 3 months ago - You have had another
immunotherapy less than 6 weeks ago - You need to have chemotherapy to relieve symptoms (palliative), radiotherapy or surgery
Medical conditions
You cannot join this study if any of these apply.
- You have had a
donor (allogenic) stem cell transplant - You have had an
organ transplant for example a liver transplant - You are not able to maintain a certain number of
platelets in the blood without needing transfusions to keep the number of platelets at a certain level - You have fits (seizures) unless they are controlled by medication
- You have an
autoimmune disease apart from vitiligo, type 1 diabetes, psoriasis that doesn’t need systemic treatment - You are taking steroids within 2 weeks of starting treatment unless it is a cream or inhaler
- You are taking any other medications that affect your
immune system within 2 weeks of starting treatment - You have HIV, hepatitis B or hepatitis C
- You have had major surgery in the past 2 weeks
- You have congestive heart failure or a problem with the way your heart beats that isn’t controlled by medication
- You have high blood pressure that isn’t controlled by medication
- You have an active infection that isn’t controlled by medication
- You have a stomach ulcer (
peptic ulcer ) that isn’t controlled by medication - You have moderate to severe nerve damage
- You have fluid on the lung (
pleural effusion ) that is causing symptoms - You have any other medical or mental health condition that your doctor or the study team think could affect you taking part
Other
You cannot join this study if any of these apply. If you are at an age where you can get pregnant and you:
- are pregnant
- are breastfeeding unless you agree to stop
Trial design
This is an international study. The team need about 36 people to join worldwide with 12 people from the UK.
There are 3 groups in this study. Those who have:
- mIBG and nivolumab (group 1)
- mIBG, nivolumab and a low dose of dinutuximab beta (group 2)
- mIBG, nivolumab and the full dose of dinutuximab beta (group 3)
Which group you are in depends on when you agree to take part in the study.
The first few people who take part will be in group 1. If they don’t have any unexpected side effects the next few people who take part will be in group 2.
If those in group 2 don’t have any bad side effects the next people will be in group 3.
This is to make sure it is safe to give all 3 treatments together.
In the UK you have mIBG at University College London Hospital (UCLH).
In the UK you have nivolumab and dinutuximab beta at Southampton Children’s Hospital.
Group 1
You have 2 treatments of mIBG, 2 weeks apart.
You start nivolumab 2 weeks after the second dose of mIBG. You have nivolumab every 2 weeks for 30 weeks.
Groups 2 and 3
You have 2 treatments of mIBG, 2 weeks apart.
You start nivolumab 2 weeks after the second dose of mIBG. You have nivolumab every 2 weeks for 30 weeks.
You start dinutuximab beta the day after starting nivolumab. You have it every 6 weeks for 30 weeks.
You have all these 3 drugs as a drip through a central line. This is attached to a pump, this makes it easier to control the amount of the drug that slowly goes into your blood stream.
mIBG
You go to University College London Hospital (UCLH) to have mIBG. You stay in for a few days after.
Because mIBG is a radioactive treatment you must stay in your room while in hospital. You have it over 30 minutes.
Nivolumab
You have nivolumab at Southampton Children’s Hospital. You have it over 1 hour as an in a clinic.
Dinutuximab beta
You have dinutuximab beta at Southampton Children’s Hospital. You have it over 10 days.
You have the first 2 treatments of dinutuximab beta in hospital. The nurses and doctor will monitor you during treatment for any side effects.
After this you might be able to have further treatments at home if your side effects aren’t too bad.
Your central line will then be attached to a small pump that is easy to carry around. You need to go back to the hospital to have the pump removed when the treatment is finished. You doctor will talk to you about this.
Samples
The team will take some extra blood samples and samples when you have your routine tests.
They will use these to find out how well the treatment is working. And to find out what happens to dinutuximab beta in the body.
Hospital visits
You see the doctor to have some tests before agreeing to take part in the study. These tests include:
- a physical examination
- blood tests
- a mIBG scan
- MRI scan or CT scan
- chest x-ray
- heart scan (
ECHO ) - heart trace (
ECG ) - ultrasound if your doctor thinks you need one
- breathing test
- bone marrow test
You see the doctor regularly during treatment. You have a mIBG scan at week 9. At week 16 you have:
- a mIBG scan
- a CT scan or MRI scan
- an ultrasound if your doctor thinks you need one
- a bone marrow test
You see the doctor 2 to 6 weeks after the end of treatment for:
- a physical examination
- blood tests
- mIBG scan
- MRI scan or CT scan
- ultrasound if your doctor thinks you need one
- bone marrow test
After treatment you see the doctor as part of the trial:
- once a month for 3 months
- then every 6 months for at least 3 years or until you start another anti cancer treatment
Side effects
Your doctor and nurse will monitor you closely for any side effects. Let them know as soon as possible if:
- you have severe side effects
- your side effects aren’t getting any better
- your side effects are getting worse
- you notice anything unusual or anything that has changed
The common side effects of mIBG are:
- a drop in the blood cells causing an increased risk of infection, bruising and bleeding (unlike chemotherapy this mightn’t become noticeable till about 6 weeks after treatment)
- a decrease in how well your
thyroid gland works
There is a very small risk that mIBG might cause another cancer such as leukaemia in the future.
in the future. The common side effects of dinutuximab beta include:
- pain when having treatment, you will have pain killing medication during treatment to help with this
- a drop in blood cells causing an increased risk of infection, bruising and bleeding
- high temperature (fever) and chills during treatment
- loss of appetite and weight
- a low amount of salts and protein in the blood
- feeling or being sick
- diarrhoea
- a change in blood pressure (high or low)
- swelling
- a fast heart beat
- coughing, wheezing and shortness of breath
- hives
- rash and itching
- a change to the way your liver or kidneys works
- red eyes (conjunctivitis), blurred vision
- the pupil of the eye stops being able to dilate and contract
- severe allergic reaction
- dizziness and not very steady on your feet
- shaking or trembling (tremor)
- tingling in hands and feet
- fits (seizures)
- severe breathing problems
- inflammation of the bowels
We have information about the side effects of nivolumab.
Your doctor will talk to you about the possible side effects of each treatment in this study before you agree to take part.
Location
London
Southampton
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Dr Juliet Gray
Supported by
Bristol-Myers Squibb
Eusa Pharma
Experimental Cancer Medicine Centre (ECMC)
Joining Against Cancer in Kids (J-A-C-K)
Solving Kids Cancer (SKC)
University Hospital Southampton NHS Foundation Trust
Freephone 0808 800 4040
Last review date
CRUK internal database number:
15887
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
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