Who can participate
- Children with newly diagnosed high-risk neuroblastoma
- Age: 18 months to 17 years
Goal
In this study, we will investigate whether adding the drug dinutuximab beta to standard “induction chemotherapy” is safe and leads to improved survival for children with newly diagnosed high-risk neuroblastoma.
In order to improve current treatment outcomes for children with high-risk neuroblastoma, new drugs and combinations of drugs need to be better investigated.
Background
Treatment for neuroblastoma consists of several components and takes approximately one-and-a-half years in total. Treatment consists of:
- Chemotherapy (“induction”)
- Surgery
- High-dose chemotherapy ('consolidation')
- Radiation therapy ('radiotherapy')
- Maintenance treatment with immunotherapy
Treatment of patients with high-risk neuroblastoma starts with chemotherapy, aimed at reducing the size of the tumor and eliminating metastases. This chemotherapy is called “induction chemotherapy". Two different treatment regimens are used in Europe: GPOH and Rapid-COJEC. Both Rapid-COJEC and GPOH (N5-N6) regimens are considered standard practice in several regions, and so far they have shown similar results.
Dinutuximab beta is a monoclonal anti-GD2 antibody used as maintenance treatment in patients with neuroblastoma after chemotherapy and autologous stem cell transplantation. Dinutuximab beta targets the GD2 protein found in large amounts on the exterior of neuroblastoma cells. This protein is not found on normal cells. The drug “tags” the neuroblastoma cells, allowing them to be recognized by the body's natural immune system. This allows the immune system to target the cancer cells.
We expect that in children receiving dinutuximab beta in addition, there will be more effect than with GPOH or Rapid-COJEC chemotherapy alone, but this has not yet been proven.