RecruitingNot ApplicableObservational

Pain in anti-GD2 therapy

Neuroblastoma is a childhood cancer. A treatment called anti-GD2 helps many children but causes terrible nerve pain because it also targets nerves. This pain can be so bad that treatment doses must be lowered or stopped, making it less effective. This study will collect blood samples from children undergoing anti-GD2 treatment. Researchers will examine these samples to understand the body's immune response and inflammation during peak pain. By comparing this information with lab models, they hope to discover why anti-GD2 causes pain and how to design future versions that are less painful but still fight cancer effectively. This could lead to better and earlier treatments, improving the lives of young cancer survivors.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University of Oxford

Enrolment target

Start

01 Mar 2025

Estimated completion

01 Sep 2027

Neuropathic pain in patients undergoing anti-GD2 therapy for neuroblastoma.

What is this study about?

Neuroblastoma is the most common cancer in very young children. There's a treatment called anti-GD2 therapy that's been very helpful for children with high-risk neuroblastoma, extending their lives and sometimes even helping them get better. However, this treatment can cause really severe pain, especially in the nerves. This happens because the treatment goes after a specific part of cancer cells (called GD2), but this same part is also found on healthy nerves throughout the body. Even with strong painkillers given before treatment, the pain can be so bad that doctors sometimes have to reduce the dose, making the treatment less powerful, or even stop it altogether.

We know that the body's immune system is important in fighting the cancer with this treatment, but it also seems to play a part in causing this pain. So, the big challenge is to find a way to reduce this pain without making the cancer treatment less effective. This study aims to understand why this pain happens. Researchers will collect blood samples from children receiving anti-GD2 treatment and look closely at the levels of inflammation and immune cells in these samples, especially when the child is experiencing the most pain.

By carefully studying these blood samples and comparing them with what we know from lab tests, the researchers hope to identify exactly what it is about the treatment and the body's reaction that causes this painful side effect. The goal is to use this knowledge to design better versions of the anti-GD2 therapy. The hope is that these new versions will still be very good at fighting neuroblastoma but will cause much less pain. This could make the treatment more effective overall and might even allow it to be given earlier in a child's treatment journey, ultimately improving the quality of life for young cancer survivors. It will also help us learn more about nerve-related side effects from immune treatments in general.

Key takeaways

Study aims to understand severe nerve pain from anti-GD2 neuroblastoma treatment.
Participation involves giving extra blood samples during routine tests and answering pain questions.
No change to your child's planned cancer treatment.
Hopes to create less painful, more effective cancer treatments for the future.
Low risk as it's an observational study with no extra needles.
Your child must be 12 months or older with high-risk neuroblastoma.

Who may be eligible?

This study is looking for children who are 12 months old or older and have been diagnosed with high-risk neuroblastoma. To join, they must be scheduled to receive the anti-GD2 treatment called dinutuximab beta.

Also, a parent or guardian needs to be able and willing to give permission for their child to participate if the child is under 16. The doctors also need to believe that the child can follow the study's requirements.

Children cannot take part if they have a lot of pain from other causes (like a recent severe injury), or if they have severe mental health conditions that might make it hard to assess their pain. If, in the doctor’s opinion, there's any other significant health problem that could put the child at risk, affect the study's results, or prevent them from participating, they won't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child 12 months old or older?
Does your child have high-risk neuroblastoma?
Is your child scheduled to receive dinutuximab beta (Qarziba) treatment?
Are you, as a parent/guardian, able to give informed consent?
Does your child have severe pain from other causes (like a recent injury)? (If yes, not eligible)
Does your child have severe mental health issues? (If yes, not eligible)

Answer every question to see your result.

What does participation involve?

If your child takes part, they will continue to receive their anti-GD2 treatment for neuroblastoma as planned. The main thing that will be different is that extra blood samples will be collected during their treatment. These extra blood samples will be taken at the same time as their usual blood tests, so there won't be any additional needles or discomfort from blood draws. The total amount of blood taken will be kept within safe limits for research.

Your child will also be asked some questions about their pain levels during their treatment. This will take just a few minutes, even if they are experiencing pain. The study staff are experienced and will try to disturb your child as little as possible. This study is ‘observational,’ meaning it involves collecting information and samples, but it won't change the treatment your child receives, whether you choose to participate or not. The study hopes to gather information from July 2024 to October 2027.

Potential risks and benefits

Taking part in this study won't directly improve your child's health right now, and any genetic information found isn't expected to have immediate medical meaning for them. However, by participating, your child will directly help scientists understand why anti-GD2 treatment causes pain. This knowledge is crucial for developing future cancer treatments that are just as effective but cause less pain, which could significantly improve the quality of life for future young cancer survivors. Because this is an observational study where your child receives their standard treatment, the risks are very low. The main risks involve taking extra blood samples (but no extra needle pokes, and within safe limits) and answering some short questions about pain, which might cause a little disturbance. Remember, you can choose to withdraw your child from the study at any time without it affecting their medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford University Hospitals NHS Foundation Trust
City only
Oxford, United Kingdom
University Hospital Southampton NHS Foundation Trust
City only
Southampton, United Kingdom

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that most commonly affects children under five years old. It starts in certain nerve cells.

What is anti-GD2 therapy?

It's an advanced antibody treatment (like Qarziba) for high-risk neuroblastoma that helps the body fight cancer cells. It's very effective but can cause severe nerve pain.

Will my child's treatment change if we join?

No, your child will receive their standard anti-GD2 treatment exactly as planned. This study is just about collecting extra information and samples.

Will there be extra needle pokes for blood samples?

No, extra blood samples will be taken at the same time as your child's routine blood tests, so no additional needle sticks are needed.

Is there any direct benefit to my child if they participate?

While there are no direct health benefits for your child right now, their participation will greatly help researchers develop better, less painful cancer treatments for other children in the future.

How to find out more

Alexander Davies

alexander.davies@ndcn.ox.ac.uk +44 (0)1865 234829 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.