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.
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.
Previous cancer-specific treatment for neuroblastoma.
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.
Parallel
Dinutuximab beta
Biological/VaccineCombination of immunotherapy with standard chemotherapy
chemotherapy treatment called GPOH
Drugchemotherapy treatment called GPOH
chemotherapy treatment called rapid COJEC
Drugchemotherapy treatment called rapid COJEC
the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with GPOH chemotherapy regimen
Number of DLT's per dose level of Dinituximab Beta
the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with rapid COJEC chemotherapy regimen
Number of DLT's per dose level of Dinituximab Beta
overall response rate during after Dinituximab Beta with GPOH chemotherapy regimen
Tumor imaging
metastatic response rate after Dinituximab Beta with GPOH chemotherapy regimen
Tumor imaging
overall response rate during after Dinituximab Beta with rapid COJEC chemotherapy regimen
Tumor imaging
metastatic response rate after Dinituximab Beta with rapid COJEC chemotherapy regimen
Tumor imaging
event free survival (EFS) from the date of enrollment
exploratory endpoints
overall survival (OS) from the date of enrollment
exploratory endpoints
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Princess Maxima Center for Pediatric Oncology
Lead sponsor
EUSA Pharma, Inc.
Collaborator
