Immunotherapy with dinutuximab beta in combination with chemotherapy for the treatment of patients with primary neuroblastoma refractory to standard therapy and with relapsed or progressive disease.
Neuroblastoma is a rare childhood cancer that develops in nerve cells. While standard treatments work for many, the cancer can sometimes come back, worsen, or resist initial therapy. When this happens, doctors need better, more effective treatment options. This Phase III clinical trial looks at combining chemotherapy with an immunotherapy medicine called dinutuximab beta (brand name Qarziba). Immunotherapies help the body's own immune system find and attack cancer cells. Dinutuximab beta is given directly into a vein through a drip. Researchers want to find out how safe this drug combination is and carefully track any side effects. They will closely monitor reactions such as fluid leaking from blood vessels, severe allergies, changes in vision, and effects on the liver, kidneys, and blood counts. This study aims to help doctors understand if this combined approach is a manageable option for difficult-to-treat neuroblastoma.
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De quoi parle cette étude ?
Neuroblastoma is a rare type of cancer that starts in early nerve cells, most commonly affecting babies and young children. For many families, standard treatments like chemotherapy and surgery are successful. However, in some cases, the cancer does not go away completely (refractory cancer), or it returns after getting better (relapsed cancer). When first-line treatments stop working, doctors urgently look for new ways to target the disease.
This clinical trial is studying an immunotherapy medication called dinutuximab beta, also known by the brand name Qarziba. Unlike traditional chemotherapy, which attacks rapidly dividing cells throughout the body, immunotherapy helps the patient's own immune defence system recognize and fight cancer cells. In this trial, dinutuximab beta is combined with chemotherapy to see if the two treatments work well together against stubborn cancer cells.
The main focus of this study is safety. Because combining strong cancer therapies can cause unwanted reactions, researchers are tracking side effects very closely. They are monitoring issues such as allergic reactions, nerve pain, swelling, vision problems, and changes in kidney or liver function. Learning how well patients tolerate this combination will help doctors decide how best to care for people facing hard-to-treat neuroblastoma in the future.
Points clés
- Tests an immunotherapy drug (dinutuximab beta) combined with chemotherapy.
- Aimed at neuroblastoma that has come back, grown, or not cleared with standard care.
- Focuses heavily on safety, carefully tracking side effects and how well the body copes.
- Involves hospital stays or day visits for infusions and regular health checks.
- Taking part is voluntary, and you are free to leave the trial at any stage.
Qui peut être éligible ?
This study is open to patients of any age who have been diagnosed with neuroblastoma that has proved difficult to treat. This includes cancer that has not responded to standard first-line therapies, cancer that has continued to grow during treatment, or cancer that has returned after a period of improvement.
Both males and females may be able to join. Because every patient's situation is unique, a specialist hospital doctor will need to run tests to confirm the exact stage of the neuroblastoma and review any previous treatments the patient has received.
Patients may not be eligible if their vital organs—such as the heart, liver, or kidneys—are not functioning well enough, or if they have serious active infections or medical conditions that could make the treatment unsafe. The study team will review each person's full medical history before deciding if taking part is a safe option.
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- Confirmed diagnosis of neuroblastoma.
- Cancer that has returned (relapsed) after previous treatment.
- Cancer that has grown (progressed) or not responded to first-line therapies.
- Able to attend regular hospital visits for infusions and safety monitoring.
- General organ function (liver, kidneys, heart) meets the hospital safety levels.
En quoi consiste la participation ?
Taking part in this trial involves receiving dinutuximab beta as a liquid drip directly into a vein (an intravenous infusion), alongside cycles of chemotherapy. Because dinutuximab beta can cause immediate side effects, the infusions are given in a hospital ward where doctors and nurses can closely watch for any changes.
Participants will have regular clinic visits. At these visits, the medical team will carry out physical examinations, eye checks, blood tests, and scans to see how the cancer is responding and check how well the body is handling the treatment. They will also look carefully for signs of nerve discomfort, swelling, or allergic responses.
Treatment is typically given in repeated cycles over several months, depending on how well the person tolerates the drugs and how the cancer responds. After finishing active treatment, patients will have regular follow-up appointments so the study team can check on their long-term health and recovery.
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Questions fréquentes
What is dinutuximab beta?
Dinutuximab beta (Qarziba) is an immunotherapy drug designed to attach to specific targets on neuroblastoma cells, helping the immune system destroy them.
How is the study medication given?
It is given as a slow drip through a tube into a vein (intravenous infusion) in a hospital setting under close medical supervision.
Why is this trial focusing so much on side effects?
Because combining immunotherapy with chemotherapy can be tough on the body, doctors must carefully test how safe it is and how to manage any reactions effectively.
Will taking part cost anything?
In the UK, trial medications are provided free of charge, though you may want to ask if travel expenses to hospital visits are covered.
Can a patient stop taking part if they change their mind?
Yes. Participation is entirely voluntary, and you or your child can leave the trial at any point without it affecting standard care.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
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