A Phase I Study of 131I-MIBG With Dinutuximab for Relapsed / Refractory Neuroblastoma
1 - 30 Years, Male and Female
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 dose escalation 3+3 design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients 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 aims to determine the recommended phase 2 pediatric dose of these two
therapies in combination.
Treatment Sites in Georgia
1405 Clifton Road NE
Atlanta, GA 30322
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