RecruitingPhase I/IIInterventional

A trial looking at different treatments for neuroblastoma which has come back after initial therapy

Neuroblastoma is a rare cancer of the nervous system that mainly affects young children. While standard treatments can be successful, the cancer can sometimes come back (relapse) or stop responding to standard therapies. When this happens, doctors urgently need better options. The BEACON2 trial is an international study led by the University of Birmingham. It tests different combinations of chemotherapy and targeted antibody treatments in patients aged one year and older. In the main part of the trial, participants are randomly assigned to receive one of two drug combinations over 3-week cycles for up to 12 cycles. Doctors hope to learn which combinations are most effective at shrinking or controlling tumours, while carefully checking side effects and quality of life. The findings will help doctors choose the most effective, kinder treatments for children facing relapsed neuroblastoma.

At a glance

Status

Recruiting

Phase

Phase I/II

Sponsor

University of Birmingham

Enrolment target

160

Start

22 Nov 2024

Estimated completion

31 Jul 2027

Relapsed Neuroblastoma

What is this study about?

Neuroblastoma is a type of childhood cancer that develops from immature nerve cells, most commonly in the tummy or around the spine. Although therapies have improved over the years, 'high-risk' neuroblastoma remains very challenging to treat. In some children, the cancer does not go away completely or returns after treatment ends. When this happens, standard treatments are often no longer enough, and new medical approaches are needed.

The BEACON2 clinical trial was designed to tackle this challenge. Led by researchers at the University of Birmingham and funded by Fight Kids Cancer, this international study tests new combinations of drugs. These treatments combine standard chemotherapy (medicines that kill fast-growing cells) with targeted medicines and immunotherapy (treatments that help the immune system recognise and attack cancer cells).

Because every child's cancer can behave differently, the trial tests these medicines in organised groups to directly compare how well they work. By gathering detailed medical information and blood or tissue samples, researchers also hope to understand why certain neuroblastomas resist treatment. The ultimate goal is to give young people with relapsed neuroblastoma a better chance of living longer, healthier lives.

Key takeaways

BEACON2 is an international clinical trial for relapsed or progressing high-risk neuroblastoma.
It is open to children and young people aged 1 year and older.
The study tests combinations of chemotherapy and targeted therapies given in 3-week cycles.
Regular scans and blood tests are used to track the tumour and manage any side effects.
Participation is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is open to children and young people aged 1 year and older who have high-risk neuroblastoma that has come back (relapsed) or progressed after previous treatment. The cancer must be visible on medical imaging, such as an MIBG scan or MRI scan. Children who only have cancer cells in their bone marrow without any visible tumour on scans cannot take part.

Participants need to be in reasonable general health to safely receive the study medicines. This means they should be able to sit up or be active for at least half of the day. Their main organs, including their kidneys, liver, and bone marrow, must be working well enough to cope with cancer treatment. A doctor will confirm these details with routine blood, urine, and imaging tests before anyone joins.

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.

The patient is at least 1 year old.
The patient has been diagnosed with high-risk neuroblastoma that has returned or grown.
The tumour can be seen on standard medical scans (such as an MIBG scan).
The patient is well enough to sit up or be active for at least half the day.
Routine tests show acceptable liver, kidney, and bone marrow function.

Answer every question to see your result.

What does participation involve?

Taking part in BEACON2 involves receiving treatment in cycles that last three weeks each, for up to 12 cycles (about 9 months in total). Participants are assigned to a treatment arm that combines chemotherapy drugs (such as irinotecan and temozolomide) with targeted antibody therapies (such as dinutuximab beta or bevacizumab). Some medicines are given as a drip into a vein at the hospital, while others may be taken by mouth as liquids or capsules at home.

Families will need to make regular visits to the hospital for treatment days, check-ups, and monitoring. Doctors will carry out routine blood and urine tests, physical examinations, and regular scans (such as MIBG or CT scans) to check how the tumour is responding and watch for any side effects. After finishing the treatment cycles, your child will have regular follow-up visits so the care team can continue to monitor their health and recovery.

Potential risks and benefits

Taking part in this study may help shrink or control the neuroblastoma, but doctors cannot guarantee that the treatment will work for every child. The study will also help doctors discover better treatments for other children in the future. Because the study uses strong cancer drugs, there is a risk of side effects, such as sickness, tiredness, lower blood cell counts, risk of infections, pain, or allergic reactions to antibody infusions. The medical team will watch your child very closely and give supportive medicines to help manage any side effects. Taking part is completely voluntary. You can choose to leave the study at any point, and your child's standard medical care will not be affected.

Locations (19)

Addenbrookes
Approximate
Cambridge, England
Alder Hey Children's NHS Foundation Trust
City only
Liverpool, England
Birmingham Childrens Hospital (ladywood)
City only
Birmingham, England
Bristol Childrens Hospital
Approximate
Bristol, England
Great North Children's Hospital
City only
Newcastle upon Tyne, England
Great Ormond Street Hospital
Unverified
London, England
John Radcliffe Hospital
Unverified
Oxford, England
Leeds General Infirmary
Unverified
Leeds, England
Noahs Ark Childrens Hospital for Wales
Unverified
Cardiff, Wales
Nottingham Children's Hospital
Unverified
Nottingham, England
Royal Aberdeen Children's Hospital
Unverified
Aberdeen, Scotland
The Royal Belfast Hospital for Sick Children
Unverified
Belfast, Northern Ireland

Common questions

What is the main goal of the BEACON2 trial?

The trial aims to find the safest and most effective drug combinations for children and young people whose neuroblastoma has returned after earlier treatment.

How is it decided which treatment my child receives?

In the main part of the trial, a computer randomly chooses which treatment group your child joins. This ensures the comparison between the drug combinations is fair and unbiased.

How long does the trial treatment last?

Treatment is given in 3-week blocks called cycles. Children can receive up to 12 cycles, which takes around 8 to 9 months, provided the treatment continues to help them.

Where does the trial take place?

The trial is coordinated by the University of Birmingham and is open at specialist children's cancer hospitals across the UK, Europe, and Australasia.

Can we stop taking part if we change our minds?

Yes. You and your child can leave the trial at any time without giving a reason. Your child's medical team will continue to offer the best available standard treatment.

How to find out more

Rebecca Reid

beacon2@trials.bham.ac.uk +44 121 4151061 Official trial record

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