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A Phase I Study of 131I-MIBG With Dinutuximab for Relapsed / Refractory Neuroblastoma


Active: Yes
Cancer Type: Neuroblastoma NCT ID: NCT03332667
Trial Phases: Phase I Protocol IDs: NANT2017-01 (primary)
NCI-2018-01160
Eligibility: 1 - 30 Years, Male and Female Study Type: Treatment
Study Sponsor: New Approaches to Neuroblastoma Treatment (NANT)
NCI Full Details: http://clinicaltrials.gov/show/NCT03332667

Summary

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.

Objectives

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

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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