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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Multi-Arm, Platform Trial For Relapsed Neuroblastoma

This study, called BEACON2, is for children and young people whose neuroblastoma has returned after initial treatment. Neuroblastoma is a type of cancer that starts in nerve cells and is a serious condition for many children. The main goal is to find new and more effective combinations of medicines to help these patients live longer and have a better quality of life. The study will look at how safe these new treatments are, how well they work, and what impact they have on daily life. Researchers will also collect samples to learn more about neuroblastoma and develop better treatments in the future.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
University of Birmingham
Enrolment target
160
Start
11 Nov 2024
Estimated completion
31 Dec 2030

What is this study about?

Neuroblastoma is a type of cancer that usually affects children. While many children are successfully treated, sometimes the cancer is very aggressive, or it comes back after treatment. When this happens, it's called 'relapsed neuroblastoma', and it can be very difficult to treat. Because of this, doctors and scientists are always looking for new and better ways to fight it. That's where studies like BEACON2 come in.

The BEACON2 study aims to improve the chances of survival for children and young people with relapsed neuroblastoma. It does this by testing different combinations of existing medicines to see which ones work best. The study wants to find treatments that are not only effective in getting rid of the cancer but also help children feel as well as possible during treatment. They will closely watch how patients react to the new combinations and whether their quality of life improves.

Along with trying new treatments, the study will also collect samples from patients, like blood or tumour tissue. These samples are really important because they help researchers understand more about neuroblastoma itself. By studying these samples, they hope to discover new clues about why the cancer comes back and how to develop even more targeted treatments in the future to stop it from returning.

Key takeaways

  • This study is for children and young people with neuroblastoma that has come back.
  • It aims to find better treatment combinations to improve survival and quality of life.
  • Different combinations of anti-cancer drugs are being tested.
  • Doctors will closely monitor your child's health and treatment response.
  • Participation involves regular hospital visits, tests, and long-term follow-up.
  • Your child's samples will help researchers learn more about neuroblastoma.

Who may be eligible?

This study is open to children and young people aged 1 year or older who have been diagnosed with neuroblastoma that has come back after previous treatment, and was considered high-risk. To join, doctors must be able to see or measure the cancer using scans or other tests. Unfortunately, if the cancer is only found by looking at bone marrow samples, without other clear signs, then this study might not be suitable.

You also need to be well enough to take part. This means your body, including your blood, kidneys, and liver, needs to be working reasonably well. Doctors will do some tests to check these things. You should also be able to do some normal daily activities, even if you need help getting around. There will be specific medical checks to make sure your body can handle the treatments.

Finally, parents or guardians will need to give their full permission for their child to join the study, and that permission needs to be recorded properly.

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.

  1. Is your child aged 1 year or older?
  2. Has your child been diagnosed with neuroblastoma that has come back?
  3. Can the cancer be clearly seen on scans or other tests, not just in bone marrow?
  4. Is your child generally well enough, with good organ function (checked by doctors)?
  5. Are you, as a parent or guardian, willing to give informed permission for your child to join?
Answer every question to see your result.

What does participation involve?

If you join the BEACON2 study, you will be assigned to one of several treatment groups like choosing Arm A or Arm B, which involve a combination of medicines given over 12 cycles, each lasting three weeks. There are also other groups, like Arm C, which might involve a slightly different combination. These treatments are given as part of your regular hospital visits.

Throughout the study, you'll have regular check-ups, scans, and blood tests to see how you're responding to the treatment and to monitor for any side effects. Researchers will also collect extra samples, like blood or bone marrow, during your routine medical procedures. These extra samples help them understand the disease better. The treatment phase itself lasts for about 9 months (12 cycles x 3 weeks), but visits and check-ups will continue for up to five years after the treatment finishes to see how you are doing in the long term. The study plans to recruit patients for three years.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive new treatments that are not yet widely available and could potentially be more effective for your child's condition. Your child's health may improve, and you will contribute to medical knowledge that could help countless other children in the future. However, new treatments can also have unexpected side effects, and there's no guarantee that the treatment will work for everyone. The study team will carefully monitor your child for any side effects and manage them as best they can. It is important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your child's future care.

Locations (23)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Sydney Children's Hospital (SCH)
    Verified postcode
    Sydney, Australia· Not yet recruiting
  • St. Anna Children´s Hospital
    Verified postcode
    Vienna, Austria· Not yet recruiting
  • Cliniques Universitaires Saint-Luc (CUSL)
    Verified postcode
    Brussels, Belgium· Not yet recruiting
  • Starship Children's Hospital (SSH)
    Verified postcode
    Auckland, New Zealand· Not yet recruiting
  • Royal Aberdeen Children's Hospital
    Verified postcode
    Aberdeen, United Kingdom· Recruiting
  • Royal Belfast Hospital for Sick Children
    Verified postcode
    Belfast, United Kingdom· Not yet recruiting
  • Birmingham Children's Hospital
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Bristol Royal Hospital for Children
    Verified postcode
    Bristol, United Kingdom· Recruiting
  • Addenbrookes Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Children's Hospital for Wales
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • Royal Hospital for Sick Children
    Verified postcode
    Edinburgh, United Kingdom· Not yet recruiting
  • Royal Hospital for Children
    Verified postcode
    Glasgow, United Kingdom· Not yet recruiting

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that develops from immature nerve cells found in several areas of the body, most commonly in the adrenal glands.

What does 'relapsed' mean?

Relapsed means the cancer has come back after it was previously treated and seemed to be gone.

What kind of treatments are being tested?

The study tests combinations of medicines like dinutuximab beta, bevacizumab, irinotecan, and temozolomide, which are used to treat cancer.

Will my child automatically receive the new treatment?

If eligible, your child will be assigned to one of the treatment groups, which could be a slightly different combination of medicines being studied.

How long will the study last for my child?

The treatment part of the study lasts around 9 months, but your child will be followed up for a total of five years to see how they are doing long-term.

How to find out more

Trial Coordinator

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Multi-Arm, Platform Trial For Relapsed Neuroblastoma…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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