45
Participants
Start Date
September 12, 2018
Primary Completion Date
February 23, 2024
Study Completion Date
February 23, 2024
131I-MIBG
Patients will receive 131I-MIBG on day 1. 131I-MIBG dose will be based on the dose level assigned at the time of patient registration
Dinutuximab
Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy. Dinutuximab dose will be based on the dose level assigned at the time of patient registration.
Vorinostat
Vorinostat will be given on day 0-13. Vorinostat dose will be based on the dose level assigned at the time of patient registration.
Sargramostim
Sargramostim (GM-CSF) will be given on day 8-17 at 250 mcg/m\^2
Potassium Iodide
Potassium iodide will be given by mouth at a dose of 6mg/kg 8-12 hours prior to infusion of 131I-MIBG on Day 1 and then 1mg/kg/dose by mouth starting 4-6 hours after completion of MIBG infusion and continuing every 4 hours on protocol days 1-7 and then 1mg/kg/dose by mouth once daily on protocol days 8-45
University of North Carolina, Chapel Hill
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta
C.S Mott Children's Hospital, Ann Arbor
University of Chicago, Comer Children's Hospital, Chicago
Cook Children's Healthcare System, Fort Worth
Children Hospital of Colorado, Aurora
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
Children's Hospital and Regional Medical Center - Seattle, Seattle
Children's Hospital Los Angeles, Los Angeles
Children's Hospital Boston, Boston
Cincinnati Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia, Philadelphia
Collaborators (1)
United Therapeutics
INDUSTRY
National Cancer Institute (NCI)
NIH
New Approaches to Neuroblastoma Therapy Consortium
OTHER