Clinical trialNCT03332667CompletedPhase 1Interventional

MIBG With Dinutuximab +/- Vorinostat

SponsorNew Approaches to Neuroblastoma Therapy ConsortiumEnrollment45Neuroblastoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Araz Marachelian, MD, MS
Children's Hospital Los Angeles
Study Director
clinicaltrials.gov ↗
Thomas Cash, MD
Children's Healthcare of Atlanta
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital Los Angeles
Los Angeles, California, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Children Hospital of Colorado
Aurora, Colorado, United States
Aflac Cancer Center and Blood Disorders Service of Children'S Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States
University of Chicago, Comer Children'S Hospital
Chicago, Illinois, United States
Children'S Hospital Boston
Boston, Massachusetts, United States
C.S Mott Children'S Hospital
Ann Arbor, Michigan, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children'S Healthcare System
Fort Worth, Texas, United States
Children'S Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DinutuximabPotassium iodideSargramostim →Vorinostat →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 12 Sept 2018
Primary completion: 23 Feb 2024
Completion: 23 Feb 2024
Last update posted: 16 Apr 2025
Registered enrollment: 45
Registry id: NCT03332667

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.