Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

December 31, 2020

Primary Completion Date

June 30, 2023

Study Completion Date

September 30, 2025

Conditions
Ganglioneuroblastoma, NodularNeuroblastoma
Interventions
PROCEDURE

Biospecimen Collection

Correlative studies

PROCEDURE

Bone Marrow Aspiration

Undergo BM aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo BM biopsy

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Dinutuximab

Given IV

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET

RADIATION

Iobenguane I-123

Undergo 123I-MIBG

DRUG

Irinotecan

Given IV

DRUG

Isotretinoin

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

Sargramostim

Given SC or IV

DRUG

Temozolomide

Given PO or via enteral tube

Trial Locations (77)

1145

Starship Children's Hospital, Grafton

2145

The Children's Hospital at Westmead, Westmead

3052

Royal Children's Hospital, Parkville

4101

Queensland Children's Hospital, South Brisbane

6009

Perth Children's Hospital, Perth

8011

Christchurch Hospital, Christchurch

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

11501

NYU Winthrop Hospital, Mineola

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

19134

Saint Christopher's Hospital for Children, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

23507

Children's Hospital of The King's Daughters, Norfolk

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32827

Nemours Children's Hospital, Orlando

33021

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt University/Ingram Cancer Center, Nashville

38105

Saint Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

43205

Nationwide Children's Hospital, Columbus

44106

Rainbow Babies and Childrens Hospital, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

55404

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis

58122

Sanford Broadway Medical Center, Fargo

60611

Lurie Children's Hospital-Chicago, Chicago

60612

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61637

Saint Jude Midwest Affiliate, Peoria

63110

Washington University School of Medicine, St Louis

63141

Mercy Hospital Saint Louis, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

70121

Ochsner Medical Center Jefferson, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

78207

Children's Hospital of San Antonio, San Antonio

78229

Methodist Children's Hospital of South Texas, San Antonio

78723

Dell Children's Medical Center of Central Texas, Austin

79410

Covenant Children's Hospital, Lubbock

79415

UMC Cancer Center / UMC Health System, Lubbock

79905

El Paso Children's Hospital, El Paso

80045

Children's Hospital Colorado, Aurora

80218

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver

83712

Saint Luke's Cancer Institute - Boise, Boise

84113

Primary Children's Hospital, Salt Lake City

85202

Banner Children's at Desert, Mesa

90027

Children's Hospital Los Angeles, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

92868

Children's Hospital of Orange County, Orange

94158

UCSF Medical Center-Mission Bay, San Francisco

94611

Kaiser Permanente-Oakland, Oakland

98105

Seattle Children's Hospital, Seattle

72202-3591

Arkansas Children's Hospital, Little Rock

06106

Connecticut Children's Medical Center, Hartford

20889-5600

Walter Reed National Military Medical Center, Bethesda

02215

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

07960

Morristown Medical Center, Morristown

B3K 6R8

IWK Health Centre, Halifax

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK