Recent MRT Trials for Neuroblastoma
| Trial | Title and location | Type and date | Status |
|---|---|---|---|
| Completed and published | |||
| LuDO | Phase IIa trial of MRT with 177Lu-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma (University of Birmingham) | [177Lu]DOTATATE, phase II, 2013–2017 | Published 2020 (27) |
| NANT 2011-01 (NCT02035137) | Randomized phase II pick winner study of 131I-MIBG, 131I-MIBG with vincristine and irinotecan, or 131I-MIBG with vorinostat for resistant/relapsed neuroblastoma (NANT) | [131I]MIBG, randomized phase II, 2014–2019 | Published 2021 (37) |
| MIITOP (NCT00960739) | Phase II study of 131I-metaiodobenzylguanidine with 5 d of topotecan for refractory or relapsed neuroblastoma (Centre Oscar Lambret) | [131I]MIBG, phase II, 2008–2015 | Published 2023 (21) |
| Accrual completed—awaiting maturation of data | |||
| ANBL1531 NCT03126916 | Testing addition of 131I-MIBG or lorlatinib to intensive therapy in people with high-risk neuroblastoma (Children’s Oncology Group) | [131I]MIBG, randomized phase III, 2018–2024 | Closed to accrual |
| MINIVAN (NCT02914405) | Phase I study of 131I MIBG followed by nivolumab and dinutuximab β-antibodies in children with relapsed/refractory neuroblastoma (University Hospital Southampton) | [131I]MIBG, phase I, 2018–2024 | Closed to accrual |
| OPTIMUM (NCT03561259) | Phase II, open label, 2-arm study of therapeutic iobenguane (131I) as single agent or in combination with vorinostat for recurrent or progressive high-risk neuroblastoma subjects (Jubilant DraxImage Inc.) | [131I]MIBG, nonrandomized phase II, 2019–2023 | Closed to accrual |
| VERITAS (NCT03165292) | Evaluation of 2 intensification treatment strategies for neuroblastoma patients with poor response to induction (European Neuroblastoma Clinical Trials Group) | [131I]MIBG, randomized phase II, 2018–2023 | Closed to accrual (terminated prematurely) |
| Omburtamab radioimmunotherapy (NCT03275402) | 131I-omburtamab radioimmunotherapy for neuroblastoma central nervous system/leptomeningeal metastases (Y-mAbs Therapeutics) | [131I]-omburtamab, phase II, 2018–2023 | Closed to accrual |
| NANT 2017-01 (NCT03332667) | MIBG with dinutuximab ± vorinostat (NANT) | [131I]MIBG, phase I, 2018–2023 | Closed to accrual |
| Open and recruiting | |||
| LuDO-N (NCT04903899) | 177Lu-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma (Karolinska institute) | [177Lu]DOTATATE, phase II | Open since 2021 and recruiting |
| NEUROBLU 02 (NCT03966651) | A clinical study evaluating safety of peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTA0-Tyr3-octreotate in children with refractory or recurrent neuroblastoma expressing somatostatin receptors (Institut Claudius Regaud) | [177Lu]DOTATATE, phase I | Open since 2023 and recruiting |
| GD2-SADA: 177Lu-DOTA complex (NCT05130255) | GD2-SADA: 177Lu-DOTA complex in patients with solid tumors known to express GD2 (Y-mAbs Therapeutics) | [177Lu] 2-step radioimmunotherapy, phase I | Open since 2022 and recruiting; amended 2024 to include neuroblastoma patients ≥ 18 y |
| Planned | |||
| MINT | Biomarker-enriched phase I/II clinical trial of 131I-MIBG therapy with talazoparib for treatment of relapsed or refractory neuroblastoma (University of Birmingham) | [131I]MIBG, phase I/II | Funded, pending regulatory approval |