Neuroblastoma
Conditions
Brief summary
Incidence of dose limiting toxicities (DLTs) associated with the combination of dinutuximab beta with GPOH (2 DLT evaluation cycles: first N6 and second N5 cycles) or rapid COJEC (first C and second B and A cycles) induction chemotherapy regimens.
Detailed description
Type, incidence, severity, seriousness and relationship to study medications for Grade 3 and 4 AEs, including laboratory abnormalities and severe adverse events (SAEs). • Cumulative incidence of treatment-related mortality and of disease-related mortality., Overall response during and after induction (primary tumor, metastases)., mCR after induction treatment. mPR according to eligibility criteria to proceed to consolidation by HDC/ASCT: mPR for bone disease: MIBG uptake (or FDG-PET uptake for MIBG-non avid tumors) completely resolved or SIOPEN score ≤3 and at least 50% reduction in MIBG score (or ≤3 bone lesions and at least 50% reduction in number of FDG-PET-avid bone lesions for MIBG-non avid tumors). mPR for bone marrow disease: CR and/or MD according to INRC. mPR for other metastatic sites
Interventions
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGHuman Albumin Baxalta 50 g/l Solution for Infusion
DRUGWater for Injections Ph. Eur.
DRUGDacarbazine Lipomed 200 mg powder for solution for injection or infusion
DRUGMitoxana 1 g Powder for Sterile Concentrate
DRUGGlucose 5% Intravenous Infusion BP
Sponsors
Prinses Maxima Centrum voor Kinderoncologie B.V.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicities (DLTs) associated with the combination of dinutuximab beta with GPOH (2 DLT evaluation cycles: first N6 and second N5 cycles) or rapid COJEC (first C and second B and A cycles) induction chemotherapy regimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| Type, incidence, severity, seriousness and relationship to study medications for Grade 3 and 4 AEs, including laboratory abnormalities and severe adverse events (SAEs). • Cumulative incidence of treatment-related mortality and of disease-related mortality., Overall response during and after induction (primary tumor, metastases)., mCR after induction treatment. mPR according to eligibility criteria to proceed to consolidation by HDC/ASCT: mPR for bone disease: MIBG uptake (or FDG-PET uptake for MIBG-non avid tumors) completely resolved or SIOPEN score ≤3 and at least 50% reduction in MIBG score (or ≤3 bone lesions and at least 50% reduction in number of FDG-PET-avid bone lesions for MIBG-non avid tumors). mPR for bone marrow disease: CR and/or MD according to INRC. mPR for other metastatic sites | — |
Countries
Austria, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed