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 Healthcare of Atlanta
Arthur M. Blank Hospital
2220 North Druid Hills Road NE
Atlanta, GA 30329
404-785-0853
www.choa.org

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