Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

BEACON: A randomised phase IIb trial of BEvACizumab added to Temozolomide ± IrinOtecan for children with refractory/relapsed Neuroblastoma

The BEACON study is a clinical trial investigating new treatment options for children diagnosed with neuroblastoma, a type of cancer that develops from nerve cells. This particular study focuses on neuroblastoma that has either returned after being treated before (relapsed) or hasn't responded well to previous treatments (refractory). Researchers are testing whether adding a drug called bevacizumab to standard chemotherapy, which includes medicines like temozolomide and irinotecan, can improve how well children respond to treatment. Bevacizumab aims to stop the cancer from growing new blood vessels, which it needs to survive. The main goal is to see if these new combinations can shrink the tumours or prevent the cancer from getting worse.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

The University Of Birmingham

Enrolment target

122

Start

13 Nov 2024

Neuroblastoma

What is this study about?

Neuroblastoma is a type of cancer that mainly affects young children. Sometimes, despite treatment, the cancer can return or not respond as well as doctors hope. When this happens, it's called relapsed or refractory neuroblastoma. Doctors are always looking for better and safer ways to treat children in this situation.

This study, called BEACON, is a "Phase IIb" clinical trial. This means it's a step closer to understanding if a new treatment works and is safe before it might be considered for wider use. The researchers are studying different combinations of existing chemotherapy drugs, like temozolomide and irinotecan, with a newer drug called bevacizumab.

Bevacizumab works by targeting the blood supply to the cancer. Cancers need new blood vessels to grow and spread. Bevacizumab helps to block the formation of these new vessels, which can starve the tumour and stop it from growing. By adding bevacizumab to standard chemotherapy, the hope is to find a more effective way to shrink the cancer or keep it under control for longer.

Key takeaways

This study explores new treatments for children with neuroblastoma that has returned or not responded to previous treatment.
It combines existing chemotherapy drugs with a new drug called bevacizumab.
Bevacizumab aims to starve the cancer by blocking its blood supply.
The main goal is to see if these new combinations can shrink tumours or stop them from growing.
Participation involves regular hospital visits for treatment and monitoring.
You can withdraw your child from the study at any time without affecting their ongoing care.

Who may be eligible?

This study is designed for children who have been diagnosed with neuroblastoma. It specifically looks at those whose cancer has either come back after previous treatment or hasn't responded well to treatments they've had before.

Both boys and girls can take part in this study, regardless of their age. The research team will carefully review each child's medical history and current health to make sure the study treatment is suitable and safe for them. This will involve checking things like recent blood test results and how well their organs are working.

There might be other specific health requirements or conditions that would mean a child can or cannot join the study. The study doctors and nurses will discuss all these details with the family if they are considering participation.

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 diagnosed with neuroblastoma?
Has their neuroblastoma come back after previous treatment, or not responded well to it?
Is your child able to come to regular hospital appointments for treatment and check-ups?
Is your child currently healthy enough to consider new treatment options, as determined by a doctor?
Do you understand that this study involves receiving different combinations of medicines, decided by chance?

Answer every question to see your result.

What does participation involve?

If your child takes part in the BEACON study, they will receive a combination of medicines. These will include standard chemotherapy drugs like temozolomide, irinotecan, cyclophosphamide, or topotecan, and for some parts of the study, the addition of bevacizumab. The specific combination will be decided by chance, which means neither you nor your doctor can choose which group your child will be in.

Your child will have regular visits to the hospital for treatment and check-ups. These visits will involve various tests, such as blood tests, scans (like MRI or CT scans), and physical examinations, to monitor their health, see how the treatment is working, and check for any side effects. These assessments will happen throughout the treatment cycles, which typically last for six cycles, but the length of participation could vary.

After the main treatment period, there will be follow-up appointments to continue monitoring your child's health and the status of their neuroblastoma. The total duration of your child's involvement in the study, including treatment and follow-up, will be fully explained by the study team.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. The potential benefit of this study is that the new combination of treatments might be more effective in shrinking your child's neuroblastoma or controlling its growth for longer compared to standard treatments alone. However, we cannot guarantee that the treatment will work for every child. As with all medicines, there is a risk of side effects. The study team will carefully monitor your child for any side effects and manage them as best they can. You will be given full information on all known potential side effects. It’s important to remember that participating in this study is completely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (5)

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

—
Unverified
Belgium
—
Unverified
Spain
—
Unverified
Netherlands
—
Unverified
France
—
Unverified
Denmark

Common questions

What is neuroblastoma?

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

What does 'relapsed' or 'refractory' mean for neuroblastoma?

'Relapsed' means the cancer has returned after it was successfully treated before. 'Refractory' means the cancer didn't respond adequately to previous treatments or continued to grow despite treatment.

What is bevacizumab and how does it work?

Bevacizumab is a drug that helps stop the cancer from forming new blood vessels, which it needs to grow and spread. By cutting off this blood supply, the aim is to slow or stop the cancer's growth.

Is my child guaranteed to get bevacizumab?

Not necessarily. This study tests different combinations of drugs. Your child would be randomly assigned to one of the treatment groups, which may or may not include bevacizumab in addition to other chemotherapy.

What is a Phase IIb trial?

A Phase IIb trial is a stage of clinical research where doctors are trying to find out if a new treatment is effective, how well it works, and to get more information about its safety in a larger group of patients.