A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
This research study is looking into a new treatment for high-risk neuroblastoma, a type of cancer mainly found in young children. The treatment involves a new medicine called hu14.18K322A (also known as daretabart), which is a type of antibody, given alongside standard chemotherapy drugs (Temozolomide and Irinotecan). The main goal is to find out how safe and effective this combination treatment is for children and young people aged 18 months to 18 years whose neuroblastoma has come back or not responded well to previous treatments. It will also help determine the best dose of the new medicine to use.
At a glance
What is this study about?
Neuroblastoma is a type of cancer that usually affects children under five years old. It starts in nerve cells outside the brain, often in the tummy or chest. For many children, this cancer is considered 'high-risk' because it has spread to other parts of the body. When the cancer spreads, it can be harder to treat, and sadly, it can come back even after initial treatment.
This study is looking at a new medicine called hu14.18K322A, also known as daretabart, which is a specially designed antibody. Antibodies are natural substances in your body that fight off illness. This new medicine is designed to target and attack cancer cells. In this study, it will be given alongside two chemotherapy medicines, Temozolomide and Irinotecan, which are drugs already used to treat cancer by stopping cancer cells from growing and dividing.
The main aim of this study is to learn more about how well this combination of medicines works and whether it is safe for children and young people with high-risk neuroblastoma. The hope is that this new combination could offer a better way to treat the cancer, especially for those whose cancer has returned or hasn't responded to other treatments. The study will first check for the best dose of hu14.18K322A to use, and then test its effects on a larger group of patients.
Key takeaways
- This study is for children and young people with high-risk neuroblastoma that has come back or not responded to past treatments.
- It tests a new antibody medicine (hu14.18K322A) combined with chemotherapy.
- The main goals are to find a safe dose and see how well the combination works.
- Participants will receive up to 12 cycles of treatment and be closely monitored.
- There are strict health checks to make sure it's safe for your child to join.
- You can stop taking part in the study at any time.
Who may be eligible?
To join this study, children and young people must be between 18 months and 18 years old when their parents or guardians give permission. They must have a confirmed diagnosis of high-risk neuroblastoma that has spread to other parts of the body. Doctors will also need to be able to measure or see the cancer clearly to check how well the treatment is working.
Participants should also generally be well enough to take part. This means they should have recovered from any serious side effects of past chemotherapy treatments. There are also specific checks to make sure important organs like the heart, kidneys, liver, and lungs are working well enough, and that their blood counts are at safe levels.
It's important that any previous major surgery for the cancer was at least two weeks ago. If a patient has had cancer in their brain or spinal cord before, it must be completely gone and showing no signs of activity. For young women who can have children, a negative pregnancy test is needed, and both males and females need to agree to use effective contraception during and for a period after the study.
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 between 18 months and 18 years old?
- Has your child been diagnosed with high-risk neuroblastoma that has spread?
- Has your child recovered from previous cancer treatments?
- Are your child's important organs (heart, kidneys, liver, lungs) generally working well?
- Is your child able to move around and do daily activities fairly well?
- If female and able to have children, is she using birth control and has had a negative pregnancy test?
What does participation involve?
If you decide to take part in this study, your child will receive up to 12 cycles of treatment. A 'cycle' is a period of treatment followed by a break. The specific details of how often the medicine is given will be explained by the study team. Throughout the treatment, your child will have regular check-ups, blood tests, and scans to monitor their health, see how well the treatment is working, and check for any side effects.
Initially, a small group of 12 patients will help doctors find the best dose of the new medicine. Once this dose is confirmed, up to 132 more patients will join the study. Each treatment cycle will involve visits to the hospital. After the treatment finishes, your child will continue to be monitored for a longer period to understand any long-term effects of the treatment. The total duration of follow-up will be discussed with you by the study team.
Potential risks and benefits
Locations (17)
- University of California San Francisco (UCSF)Verified postcodeSan Francisco, United States· Recruiting
- Children's Hospital Colorado Anschutz MedicalVerified postcodeAurora, United States· Recruiting
- The University of ChicagoVerified postcodeChicago, United States· Recruiting
- University of Minnesota Masonic Children's HospitalVerified postcodeMinneapolis, United States· Recruiting
- The Children's Hospital at MontefioreVerified postcodeThe Bronx, United States· Recruiting
- Duke University Medical CenterVerified postcodeDurham, United States· Recruiting
- Children's Hospital of PhiladelphiaVerified postcodePhiladelphia, United States· Recruiting
- University of Texas SouthwesternVerified postcodeDallas, United States· Recruiting
- The Hospital for Sick ChildrenVerified postcodeToronto, Canada· Recruiting
- RigshospitaletVerified postcodeCopenhagen, Denmark· Recruiting
- Gustave RoussyVerified postcodeVillejuif, France· Recruiting
- Charité - Universitätsmedizin BerlinVerified postcodeBerlin, Germany· Recruiting
Common questions
What is high-risk neuroblastoma?
It's a type of cancer found in young children, usually under five, where the cancer has spread from where it started to other parts of the body, making it harder to treat.
What is hu14.18K322A (daretabart)?
It's a new antibody-based medicine designed to specifically target and attack neuroblastoma cancer cells. It's being tested with chemotherapy in this study.
Will my child definitely get the new treatment?
Yes, all participants in this study will receive the combination of hu14.18K322A and chemotherapy, as it's testing a specific combination of medicines.
How long will the study last for my child?
Your child could receive up to 12 cycles of treatment, and then there will be a period of follow-up monitoring to check their health over the long term. The exact duration will be explained.
Can we stop participating at any time?
Yes, you can withdraw your child from the study at any point, for any reason, and this will not affect their regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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