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Active not recruitingOBSERVATIONAL

Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

This study focuses on young children with ependymoma, a type of brain tumour. Doctors want to understand how well a standard combination of chemotherapy medicines works for these children and to learn about any long-term effects of this treatment, such as on their hearing, kidney function, or thinking abilities. By carefully watching these children, the study aims to gather important information. This information will help doctors develop better and safer ways to treat ependymoma in the future, ultimately improving the health and well-being of young patients.

At a glance

Status
Active not recruiting
Sponsor
Children's Cancer and Leukaemia Group
Enrolment target
50
Start
01 Apr 2008

What is this study about?

This research study is about understanding and improving care for very young children who have a type of brain tumour called ependymoma. When children are diagnosed with ependymoma, doctors often use a standard combination of powerful medicines, known as chemotherapy, to try and treat the tumour.

The main idea of this study is to carefully watch how these young patients react to this standard chemotherapy. Doctors want to see how well it helps control the tumour and, just as importantly, to understand any lasting changes or side effects the treatment might have on the children as they grow up. This includes looking at things like their hearing, how their kidneys are working, and their thinking and learning abilities. By gathering all this information, researchers hope to find ways to make treatments even better and gentler in the future.

Ultimately, this study is a way for doctors to learn more about ependymoma and its treatment. The goal is to collect vital information that can help doctors worldwide make more informed decisions and offer the best possible care for children facing this specific brain tumour.

Key takeaways

  • This study helps doctors learn about standard chemotherapy for young children with ependymoma.
  • It aims to understand both how effective the treatment is and its long-term effects.
  • Children in the study receive accepted, standard care, not experimental treatments.
  • Doctors will monitor hearing, kidney function, and learning abilities.
  • The information gathered will help improve future treatments for children.

Who may be eligible?

This study is for children aged two years or younger who have been diagnosed with a specific type of brain tumour called ependymoma. It's important that their tumour is a particular grade (WHO grade 2 or 3) and not other specific types of ependymoma.

To join, children must have either had their tumour completely removed by surgery, or have some tumour remaining, or have the cancer spread. They should have had surgery or previous treatment for their tumour within the last three weeks, or be unable to have chemotherapy for personal reasons or doctor's advice.

Children must also be generally well enough to receive fluids through a drip and not have any active infections. This study is not looking for children who have certain other types of ependymoma or who don't meet these specific health conditions.

Quick self-check
  • Is your child aged 2 years or younger?
  • Does your child have a WHO grade 2 or 3 ependymoma (not myxopapillary, subependymoma, or ependymoblastoma)?
  • Has your child recently had surgery for the tumour, or completed previous treatment for it?
  • Can your child tolerate receiving fluids through a drip?
  • Does your child currently have an active infection?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, they will receive a standard combination of chemotherapy medicines. These medicines, including vincristine, carboplatin, methotrexate, cyclophosphamide, and cisplatin, will be given through a drip (IV) on specific days over an eight-week cycle. This treatment will repeat for seven cycles, as long as the disease doesn't get worse and your child tolerates the treatment well. The doctors might adjust part of the methotrexate dose for some children.

Throughout the study, your child will have regular check-ups. These include physical and nervous system examinations, as well as special scans like MRI to look at the brain. There will also be tests to assess their hearing, kidney function, and thinking abilities over time. The study will continue to monitor these aspects after the main treatment is finished, to understand any long-term effects. This is a multi-centre study, meaning it happens at different hospitals.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. The potential benefit here is that the information gathered from your child's treatment could help doctors learn more about ependymoma and find better ways to treat it for future patients. There's no guarantee of direct benefit to your child beyond the standard care they would receive. However, they will be closely monitored, which can be reassuring. The risks involve the known side effects of the chemotherapy medicines your child will receive, such as effects on kidney function, hearing, and learning abilities, which the study will carefully track. You always have the right to withdraw your child from the study at any time without affecting their ongoing medical care.

Locations (10)

  • Birmingham Children's Hospital
    Birmingham, United Kingdom
  • Addenbrooke's Hospital
    Cambridge, United Kingdom
  • Leeds Cancer Centre at St. James's University Hospital
    Leeds, United Kingdom
  • Royal Liverpool Children's Hospital, Alder Hey
    Liverpool, United Kingdom
  • Great Ormond Street Hospital for Children
    London, United Kingdom
  • Royal Manchester Children's Hospital
    Manchester, United Kingdom
  • Queen's Medical Centre
    Nottingham, United Kingdom
  • Children's Hospital - Sheffield
    Sheffield, United Kingdom
  • Aberdeen Royal Infirmary
    Aberdeen, United Kingdom
  • Royal Hospital for Sick Children
    Glasgow, United Kingdom

Common questions

What is an ependymoma?

An ependymoma is a type of tumour that grows in the brain or spinal cord, usually affecting young children.

What does 'standard combination chemotherapy' mean?

It means your child will receive a mix of different anti-cancer medicines that are commonly used together to treat ependymoma.

Will my child get different treatment if they join this study?

No, your child will receive the standard treatment for ependymoma. This study is observing how that standard treatment works and what its long-term effects are.

What kind of long-term effects are you looking for?

Doctors will monitor things like your child's hearing, how well their kidneys work, and how their thinking and learning abilities develop over time.

Who is funding this research?

The information provided does not specify the funding body for this particular trial.

How to find out more

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

Discussion

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