In short
There is currently 1 ongoing clinical trial for central nervous system neuroblastoma, testing a combination of dinutuximab beta with chemotherapy in children and adolescents with newly diagnosed high-risk disease. The trial is being conducted across multiple European countries.
Clinical trial locations
- Austria
- France
- Germany
- Italy
- Netherlands
- Poland
- Spain
Study on Dinutuximab Beta with Chemotherapy for Children and Teens with Newly Diagnosed High-Risk Neuroblastoma
This trial is testing a treatment combination for children and adolescents who have been newly diagnosed with high-risk neuroblastoma. The study focuses on using dinutuximab beta, a type of monoclonal antibody that helps the immune system recognize and destroy cancer cells, together with various chemotherapy drugs.
Main inclusion criteria: To participate in this trial, patients must have a confirmed diagnosis of neuroblastoma Stage M, which means the cancer has spread to other parts of the body. Participants need to be at least 18 months old but younger than 18 years of age, and must weigh more than 12 kilograms. Certain liver function tests, including alanine transaminase (ALT) and aspartate aminotransferase (AST), must be within specific acceptable limits.
Main exclusion criteria: Patients cannot join the trial if they do not have a confirmed diagnosis of high-risk neuroblastoma, or if they fall outside the required age range. Those who are pregnant or breastfeeding are not eligible, nor are those who have recently participated in another clinical trial. Patients with allergies to the study medications, certain infections or diseases that could interfere with the treatment, or those unable to safely receive the study treatments due to other health conditions will also be excluded.
Focus and goal: The main purpose of this trial is to determine how safe and tolerable the combination of dinutuximab beta with chemotherapy is for young patients with high-risk neuroblastoma. Researchers aim to find the best dose that can be used safely. The treatment is given in cycles, which means patients receive medication followed by rest periods. Throughout the study, patients are closely monitored for any side effects and to see how their cancer responds to the treatment.
Investigational drugs: The trial uses dinutuximab beta as the main investigational medication, combined with various chemotherapy regimens. These chemotherapy regimens may include drugs such as dacarbazine, etoposide, cisplatin, vincristine sulfate, ifosfamide, carboplatin, doxorubicin hydrochloride, and cyclophosphamide. These are administered as solutions for infusion or injection. The chemotherapy combinations being tested include induction regimens known as GPOH or rapid COJEC, which are designed to shrink tumors and kill cancer cells during the initial treatment phase.
Summary
Currently, there is one ongoing clinical trial for central nervous system neuroblastoma, specifically targeting high-risk disease in children and adolescents. This trial is being conducted across seven European countries: Austria, France, Germany, Italy, Netherlands, Poland, and Spain, showing a broad European collaboration in pediatric cancer research. The study focuses on evaluating dinutuximab beta, a monoclonal antibody therapy, in combination with standard chemotherapy regimens. This approach represents a targeted treatment strategy that aims to help the immune system fight cancer cells while using established chemotherapy drugs to attack the disease. The trial's emphasis on finding the optimal dose and assessing safety reflects the careful approach needed when treating pediatric patients with aggressive cancers.
