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MIBG With Dinutuximab +/- Vorinostat

Active: No
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 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.

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 and vorinostat aims to determine the recommended phase 2 pediatric dose of
these three 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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