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
- Berlin, Cologne, Greifswald, and Tuebingen, GermanySee the 4 sites
- Phase
- Phase 1
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 Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- University of CologneCologne, GermanyTaking people
- Universitaetsmedizin Greifswald KöRGreifswald, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking 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.