Tests dinutuximab beta with two chemotherapy regimens in children with neuroblastoma
Tests dinutuximab beta with chemotherapy in newly diagnosed high-risk neuroblastoma patients.
Plain-language title generated from the registry record
Registry title: Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Key facts
- Where
- Vienna, AustriaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with newly diagnosed high-risk neuroblastoma (stage M) who have not yet had treatment for it. It tests dinutuximab beta together with two chemotherapy regimens.
- Age
- From 18 months up to under 18 years
- Sex
- All sexes can join
- Disease stage
- Neuroblastoma stage M (INRG and INSS criteria), newly diagnosed, high risk
- Earlier treatment
- Cannot have had any earlier cancer treatment for neuroblastoma
Main reasons for not taking part
- Earlier cancer-specific treatment for neuroblastoma
- Pregnancy, positive pregnancy test or breastfeeding
- Spinal cord involvement
- Major surgery within 21 days before the first dose
- Taking a prohibited medicine, such as corticosteroids, IV immunoglobulins or dexrazoxane
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Is the patient pregnant or breastfeeding?
Source: NCT06485947, who can take part
Where in Austria
- St. Anna Kinderspital GmbHVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Princess Maxima Center for Pediatric Oncology
- Trial code
- NCT06485947EU 2023-509673-22-00
- Record updated
- 8 July 2025
- Original description
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is:Read full original descriptionShow less
Phase Ib Study Combining Dinutuximab Beta With Induction Chemotherapy Regimens in Patients With Newly Diagnosed High-risk Neuroblastoma
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is:
• to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens
Participants will receive:
* GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals. * Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.
Inclusion: Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1); Age ≥18 months and <18 years; Body weight >12 kg; Alanine transaminase and aspartate aminotransferase <10 × upper limit of normal (ULN), total bilirubin <1.5 × ULN based on age specific reference ranges; Calculated glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine <1.5 × ULN corrected for age; Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) >50% as determined by echocardiography or MUGA; Able to comply with scheduled follow-up and study procedures; Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national law and legislation.
Exclusion: Current use of a prohibited medication or requires any of these medications during the study:; Treatment with corticosteroids is not allowed within 2 weeks prior to the first block of chemotherapy and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions; Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course; Concomitant use of intravenous (IV) immunoglobulins is not allowed; Concomitant use of cardioprotectant dexrazoxane is not allowed; Major surgery within 21 days prior to the first treatment dose; Previous cancer-specific treatment for neuroblastoma; History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed; Have a known immediate or delayed hypersensitivity reaction to study drugs; Any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug; Pregnancy or positive pregnancy test in females of childbearing potential; Breast feeding; Sexually active participants not willing to use highly effective contraceptive method; Patients with spinal cord involvement.