Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

478

Participants

Timeline

Start Date

April 19, 2024

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Ganglioneuroblastoma, NodularNeuroblastoma
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Dinutuximab

Given IV

DRUG

Doxorubicin

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Etoposide

Given IV

PROCEDURE

FDG-Positron Emission Tomography and Computed Tomography Scan

Undergo FDG PET

PROCEDURE

Hematopoietic Cell Transplantation

Undergo stem cell infusion

DRUG

Irinotecan

Given IV

DRUG

Isotretinoin

Given PO

PROCEDURE

Leukapheresis

Undergo apheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Melphalan

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Radionuclide Imaging

Undergo I-MIBG scan

OTHER

Survey Administration

Ancillary studies

DRUG

Temozolomide

Given PO or via NG or G tube

DRUG

Thiotepa

Given IV

DRUG

Topotecan

Given IV

PROCEDURE

Tumor Resection

Undergo tumor resection surgery

DRUG

Vincristine

Given IV

Trial Locations (170)

1145

RECRUITING

Starship Children's Hospital, Grafton

2031

SUSPENDED

Sydney Children's Hospital, Randwick

2145

SUSPENDED

The Children's Hospital at Westmead, Westmead

3052

SUSPENDED

Royal Children's Hospital, Parkville

4101

SUSPENDED

Queensland Children's Hospital, South Brisbane

6009

SUSPENDED

Perth Children's Hospital, Perth

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10032

RECRUITING

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

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

10595

RECRUITING

New York Medical College, Valhalla

11040

RECRUITING

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

12208

RECRUITING

Albany Medical Center, Albany

13210

RECRUITING

State University of New York Upstate Medical University, Syracuse

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

14642

RECRUITING

University of Rochester, Rochester

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17822

RECRUITING

Geisinger Medical Center, Danville

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19134

RECRUITING

Saint Christopher's Hospital for Children, Philadelphia

19803

RECRUITING

Alfred I duPont Hospital for Children, Wilmington

20010

RECRUITING

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

21201

RECRUITING

University of Maryland/Greenebaum Cancer Center, Baltimore

21215

RECRUITING

Sinai Hospital of Baltimore, Baltimore

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

RECRUITING

Duke University Medical Center, Durham

27834

RECRUITING

East Carolina University, Greenville

28203

RECRUITING

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28204

RECRUITING

Novant Health Presbyterian Medical Center, Charlotte

28801

RECRUITING

Mission Hospital, Asheville

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

29425

RECRUITING

Medical University of South Carolina, Charleston

29605

RECRUITING

BI-LO Charities Children's Cancer Center, Greenville

30329

RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

32207

RECRUITING

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

RECRUITING

University of Florida Health Science Center - Gainesville, Gainesville

32803

RECRUITING

AdventHealth Orlando, Orlando

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

32827

RECRUITING

Nemours Children's Hospital, Orlando

33021

RECRUITING

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

33136

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33155

RECRUITING

Nicklaus Children's Hospital, Miami

33316

RECRUITING

Broward Health Medical Center, Fort Lauderdale

33407

RECRUITING

Saint Mary's Medical Center, West Palm Beach

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

33908

RECRUITING

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

RECRUITING

Children's Hospital of Alabama, Birmingham

36604

RECRUITING

USA Health Strada Patient Care Center, Mobile

37203

RECRUITING

The Children's Hospital at TriStar Centennial, Nashville

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

37916

RECRUITING

East Tennessee Childrens Hospital, Knoxville

38105

RECRUITING

Saint Jude Children's Research Hospital, Memphis

39216

RECRUITING

University of Mississippi Medical Center, Jackson

40202

RECRUITING

Norton Children's Hospital, Louisville

40536

RECRUITING

University of Kentucky/Markey Cancer Center, Lexington

43205

RECRUITING

Nationwide Children's Hospital, Columbus

43606

RECRUITING

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo

44106

RECRUITING

Rainbow Babies and Childrens Hospital, Cleveland

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

44308

RECRUITING

Children's Hospital Medical Center of Akron, Akron

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

RECRUITING

Dayton Children's Hospital, Dayton

46202

RECRUITING

Riley Hospital for Children, Indianapolis

48073

RECRUITING

Corewell Health Children's, Royal Oak

48109

RECRUITING

C S Mott Children's Hospital, Ann Arbor

48201

RECRUITING

Children's Hospital of Michigan, Detroit

49007

RECRUITING

Bronson Methodist Hospital, Kalamazoo

49503

RECRUITING

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids

50309

RECRUITING

Blank Children's Hospital, Des Moines

52242

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

RECRUITING

Children's Hospital of Wisconsin, Milwaukee

53792

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54301

SUSPENDED

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54449

SUSPENDED

Marshfield Medical Center-Marshfield, Marshfield

55404

RECRUITING

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

55455

RECRUITING

University of Minnesota/Masonic Cancer Center, Minneapolis

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

60068

RECRUITING

Advocate Children's Hospital-Park Ridge, Park Ridge

60453

RECRUITING

Advocate Children's Hospital-Oak Lawn, Oak Lawn

60611

RECRUITING

Lurie Children's Hospital-Chicago, Chicago

60612

RECRUITING

University of Illinois, Chicago

60637

RECRUITING

University of Chicago Comprehensive Cancer Center, Chicago

61637

RECRUITING

Saint Jude Midwest Affiliate, Peoria

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

63110

RECRUITING

Washington University School of Medicine, St Louis

63141

RECRUITING

Mercy Hospital Saint Louis, St Louis

64108

RECRUITING

Children's Mercy Hospitals and Clinics, Kansas City

67214

RECRUITING

Wesley Medical Center, Wichita

68114

RECRUITING

Children's Hospital and Medical Center of Omaha, Omaha

68198

RECRUITING

University of Nebraska Medical Center, Omaha

70118

RECRUITING

Children's Hospital New Orleans, New Orleans

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

74136

RECRUITING

Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa

75230

RECRUITING

Medical City Dallas Hospital, Dallas

75390

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

RECRUITING

Cook Children's Medical Center, Fort Worth

77030

RECRUITING

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

RECRUITING

M D Anderson Cancer Center, Houston

78207

RECRUITING

Children's Hospital of San Antonio, San Antonio

78229

RECRUITING

Methodist Children's Hospital of South Texas, San Antonio

RECRUITING

University of Texas Health Science Center at San Antonio, San Antonio

78411

RECRUITING

Driscoll Children's Hospital, Corpus Christi

78723

RECRUITING

Dell Children's Medical Center of Central Texas, Austin

79410

RECRUITING

Covenant Children's Hospital, Lubbock

79415

RECRUITING

UMC Cancer Center / UMC Health System, Lubbock

79905

RECRUITING

El Paso Children's Hospital, El Paso

80045

RECRUITING

Children's Hospital Colorado, Aurora

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

85016

RECRUITING

Phoenix Childrens Hospital, Phoenix

85202

RECRUITING

Banner Children's at Desert, Mesa

85719

RECRUITING

Banner University Medical Center - Tucson, Tucson

87106

RECRUITING

University of New Mexico Cancer Center, Albuquerque

89135

SUSPENDED

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

90095

RECRUITING

Mattel Children's Hospital UCLA, Los Angeles

90242

RECRUITING

Kaiser Permanente Downey Medical Center, Downey

90806

RECRUITING

Miller Children's and Women's Hospital Long Beach, Long Beach

91010

RECRUITING

City of Hope Comprehensive Cancer Center, Duarte

92354

RECRUITING

Loma Linda University Medical Center, Loma Linda

92868

RECRUITING

Children's Hospital of Orange County, Orange

93636

RECRUITING

Valley Children's Hospital, Madera

94158

RECRUITING

UCSF Medical Center-Mission Bay, San Francisco

94304

RECRUITING

Lucile Packard Children's Hospital Stanford University, Palo Alto

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland, Oakland

94611

RECRUITING

Kaiser Permanente-Oakland, Oakland

95816

RECRUITING

Sutter Medical Center Sacramento, Sacramento

95817

RECRUITING

University of California Davis Comprehensive Cancer Center, Sacramento

96826

RECRUITING

Kapiolani Medical Center for Women and Children, Honolulu

97227

RECRUITING

Legacy Emanuel Children's Hospital, Portland

97239

RECRUITING

Oregon Health and Science University, Portland

98105

RECRUITING

Seattle Children's Hospital, Seattle

98405

RECRUITING

Mary Bridge Children's Hospital and Health Center, Tacoma

99204

RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

72202-3591

RECRUITING

Arkansas Children's Hospital, Little Rock

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

06520

RECRUITING

Yale University, New Haven

04401

RECRUITING

Eastern Maine Medical Center, Bangor

04074

RECRUITING

Maine Children's Cancer Program, Scarborough

02114

RECRUITING

Massachusetts General Hospital Cancer Center, Boston

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

03756

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07601

RECRUITING

Hackensack University Medical Center, Hackensack

07960

RECRUITING

Morristown Medical Center, Morristown

08901

RECRUITING

Saint Peter's University Hospital, New Brunswick

08903

RECRUITING

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick

07503

RECRUITING

Saint Joseph's Regional Medical Center, Paterson

02903

RECRUITING

Rhode Island Hospital, Providence

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05405

RECRUITING

University of Vermont and State Agricultural College, Burlington

23708-2197

RECRUITING

Naval Medical Center - Portsmouth, Portsmouth

T3B 6A8

SUSPENDED

Alberta Children's Hospital, Calgary

T6G 2B7

SUSPENDED

University of Alberta Hospital, Edmonton

V6H 3V4

SUSPENDED

British Columbia Children's Hospital, Vancouver

R3E 0V9

SUSPENDED

CancerCare Manitoba, Winnipeg

A1B 3V6

SUSPENDED

Janeway Child Health Centre, St. John's

B3K 6R8

SUSPENDED

IWK Health Centre, Halifax

L8N 3Z5

SUSPENDED

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

N6A 5W9

SUSPENDED

Children's Hospital, London

K1H 8L1

SUSPENDED

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

SUSPENDED

Hospital for Sick Children, Toronto

H3H 1P3

SUSPENDED

The Montreal Children's Hospital of the MUHC, Montreal

H3T 1C5

SUSPENDED

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

SUSPENDED

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

S7N 0W8

SUSPENDED

Jim Pattison Children's Hospital, Saskatoon

G1V 4G2

SUSPENDED

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), Québec

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH