MIBG With Dinutuximab +/- Vorinostat

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 12, 2018

Primary Completion Date

February 23, 2024

Study Completion Date

February 23, 2024

Conditions
Neuroblastoma
Interventions
RADIATION

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

DRUG

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.

DRUG

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.

DRUG

Sargramostim

Sargramostim (GM-CSF) will be given on day 8-17 at 250 mcg/m\^2

DRUG

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

Trial Locations (12)

27599

University of North Carolina, Chapel Hill

30322

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta

48109

C.S Mott Children's Hospital, Ann Arbor

60637

University of Chicago, Comer Children's Hospital, Chicago

76104

Cook Children's Healthcare System, Fort Worth

80045

Children Hospital of Colorado, Aurora

94143

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

98105

Children's Hospital and Regional Medical Center - Seattle, Seattle

90027-0700

Children's Hospital Los Angeles, Los Angeles

02115

Children's Hospital Boston, Boston

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

19104-4318

Children's Hospital of Philadelphia, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

United Therapeutics

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

New Approaches to Neuroblastoma Therapy Consortium

OTHER

NCT03332667 - MIBG With Dinutuximab +/- Vorinostat | Biotech Hunter | Biotech Hunter