RecruitingPhase IIInterventional

Radiotherapy (miBG) in neuroblastoma combined with chemotherapy (talazoparib)

This study, called MINT, is for children and young people over one year old who have neuroblastoma that has come back or hasn't responded to initial treatments. Neuroblastoma is a type of childhood cancer. The study combines a special radiation treatment called 131I-mIBG with a chemotherapy drug called talazoparib. Researchers want to see if talazoparib helps the radiation work better by making cancer cells more sensitive to it. They will also look at whether certain changes in a patient's genes affect how well this treatment works. The information gained will help improve future treatments for neuroblastoma.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Birmingham

Enrolment target

Start

01 Dec 2024

Estimated completion

30 Jun 2028

Relapsed and refractory high-risk neuroblastoma

What is this study about?

The MINT study is a medical research project looking for better ways to treat a type of cancer called neuroblastoma in children and young adults. Neuroblastoma is the most common solid tumour found outside the brain in children, and it can be very serious. Sadly, for many children, the cancer either doesn't respond to the first treatments or comes back after treatment. This is what doctors call "relapsed or refractory" neuroblastoma.

Currently, a treatment called 131I-mIBG therapy is used. This is a special type of radiation that targets the cancer cells. However, it doesn't always work for everyone. In this study, doctors are combining this radiation therapy with a drug called talazoparib. This drug belongs to a group called PARP inhibitors. Lab studies have shown that PARP inhibitors can make cancer cells more sensitive to radiation, meaning the radiation might work better. We want to see if this combination of 131I-mIBG and talazoparib is more effective at treating neuroblastoma.

We are also interested in how a patient's genes might play a role. Some neuroblastoma cells have specific gene changes that make it harder for them to fix damage to their DNA. We think that talazoparib might be particularly helpful for these patients. By taking part in this study, you would be helping us learn more about how to fight neuroblastoma, which could lead to improved treatments for children in the future.

Key takeaways

This study is for children and young adults with high-risk neuroblastoma that has returned or hasn't responded to previous treatment.
It tests a new combination treatment: targeted radiation (131I-mIBG) plus a drug (talazoparib).
The aim is to see if this combination works better, especially for those with specific gene changes.
Participation involves one course of treatment, a stem cell rescue, and at least two years of follow-up.
Potential benefits include better treatment, but there are risks from the treatments and extra tests.
The study helps improve future neuroblastoma treatments.

Who may be eligible?

To be considered for this study, patients must be older than one year of age and have been diagnosed with high-risk neuroblastoma that has either returned or hasn't improved with previous treatments.

Your medical team will need to confirm that scans show your neuroblastoma is still active and that you have enough healthy stem cells available for a special procedure after treatment. They will also check your general health and how well you can do daily activities. You will need to have some previous treatment information or a recent genetic test report available for the study doctors to review.

There are also some requirements about when your last treatments were. For example, you must have finished certain chemotherapies at least two weeks before joining the study, and radiation therapy at least two weeks beforehand. Your doctor will carefully review all your medical information to see if this study is right for you.

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.

Are you over one year old?
Do you have high-risk neuroblastoma that has come back or hasn't responded to other treatments?
Do scans show that your neuroblastoma is still active and can be targeted by the 131I-mIBG treatment?
Do you have enough healthy stem cells available for a stem cell rescue?
Are you generally well enough to take part, as assessed by your doctor?
Have you finished any previous treatments within the required timeframe before joining?

Answer every question to see your result.

What does participation involve?

If you join the study, you will receive two treatments: the drug talazoparib and the targeted radiation therapy 131I-mIBG. Doctors will closely monitor your reaction to these treatments. You will receive one course of this combined treatment. After that, you will have a special procedure called a stem cell rescue, which helps your body recover from the treatment.

During your time in the study, you will have regular visits with the medical team. This will involve physical examinations, blood tests, and imaging scans (like X-rays or MRI scans) to see how you are responding to the treatment and to check for any side effects. Some blood tests might be taken at the same time as your routine blood tests to minimise any discomfort. You will be followed up for at least two years after your treatment to keep track of your health and the long-term effects of the treatment.

Potential risks and benefits

The main potential benefit of taking part in this trial is that the new treatment combination might help to treat your neuroblastoma more effectively than standard treatments. While we can't promise specific results, the information gained will definitely help doctors improve future treatments for children with neuroblastoma. However, like all medical treatments, there are potential risks. The radiation and drugs can cause side effects, and you will have more medical tests, including scans that involve some radiation exposure, than if you weren't in the study. There's also a small risk of allergic reactions to dyes used for some scans. If you or your partner could become pregnant, it's very important to use reliable contraception during and for some time after the study because the treatment could harm an unborn baby. You will be closely monitored for any known or unknown side effects throughout the study, and you are free to withdraw from the study at any time.

Locations (6)

The Royal Marsden Hospital
Approximate
London, United Kingdom
Royal Hospital for Sick Children (Glasgow)
Approximate
Glasgow, United Kingdom
Uclh
Approximate
London, United Kingdom
Hospital for Sick Children
Approximate
Toronto, Canada
Princess Máxima Center for Pediatric Oncology
City only
Utrecht, Netherlands
Charité Universitätsmedizin Berlin
Unverified
Berlin, Germany

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that usually affects children and young adults, often developing in nerve tissue outside of the brain.

What is I-131-mIBG therapy?

This is a special treatment that uses a mild radioactive substance, 131I-mIBG, that targets and delivers radiation directly to neuroblastoma cells.

What is talazoparib?

Talazoparib is a drug that might make neuroblastoma cells more sensitive to radiation therapy, potentially making the treatment more effective.

Will I have more tests if I join this study?

Yes, you will likely have more blood tests and imaging scans (like X-rays or MRI) to help doctors understand how the treatment is working.

Where is this study taking place?

The study is based out of the University of Birmingham in the UK, but patients from different locations may be able to participate.

How to find out more

Catherine Cochrane

mint@trials.bham.ac.uk +44 (0)7814 650003 Official trial record

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