MIBG With Dinutuximab +/- Vorinostat

  • End date
    Mar 25, 2023
  • participants needed
  • sponsor
    New Approaches to Neuroblastoma Therapy Consortium
Updated on 25 May 2022
monoclonal antibodies
bone marrow procedure
tumor cells
monoclonal antibody ch14.18


131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will utilize a traditional Phase I rolling 6 dose escalation design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients will then be enrolled. If tolerable, vorinostat will then be added to the third dose level. A 6 patient expansion cohort may then be enrolled.


131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. Data from pre-clinical and adult studies suggest that radiation can enhance the efficacy of immunotherapy and targeted therapies such as dinutuximab. This first pediatric phase 1 trial of 131I-MIBG in combination with dinutuximab and vorinostat aims to determine the recommended phase 2 pediatric dose of these three therapies in combination.

Condition Neuroblastoma
Treatment Vorinostat, sargramostim, Dinutuximab, 131I-MIBG, Ch14.18 Monoclonal Antibody, Potassium Iodide
Clinical Study IdentifierNCT03332667
SponsorNew Approaches to Neuroblastoma Therapy Consortium
Last Modified on25 May 2022


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