Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

PHASE3RecruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

May 14, 2018

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
GanglioneuroblastomaGanglioneuroblastoma, NodularNeuroblastoma
Interventions
PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous HSCT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Busulfan

Given IV

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Dexrazoxane Hydrochloride

Given IV

BIOLOGICAL

Dinutuximab

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

DRUG

Etoposide Phosphate

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

RADIATION

Iobenguane I-123

Given 123 I-MIBG

RADIATION

Iobenguane I-131

Given IV

DRUG

Isotretinoin

Given PO

DRUG

Lorlatinib

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Melphalan Hydrochloride

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Positron Emission Tomography

Undergo PET scan

BIOLOGICAL

Sargramostim

Given SC

PROCEDURE

Therapeutic Conventional Surgery

Undergo standard of care surgery

DRUG

Thiotepa

Given IV

DRUG

Topotecan Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

Trial Locations (161)

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

11219

RECRUITING

Maimonides Medical Center, Brooklyn

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

11794

RECRUITING

Stony Brook University Medical Center, Stony Brook

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

17033

RECRUITING

Penn State Children's Hospital, Hershey

17822

RECRUITING

Geisinger Medical Center, Danville

18103

RECRUITING

Lehigh Valley Hospital-Cedar Crest, Allentown

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19803

RECRUITING

Alfred I duPont Hospital for Children, Wilmington

20010

RECRUITING

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

21215

RECRUITING

Sinai Hospital of Baltimore, Baltimore

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

26506

SUSPENDED

West Virginia University Healthcare, Morgantown

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

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

31404

RECRUITING

Memorial Health University Medical Center, Savannah

32207

RECRUITING

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

RECRUITING

University of Florida Health Science Center - Gainesville, Gainesville

32803

RECRUITING

AdventHealth Orlando, 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

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

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

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

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

ACTIVE_NOT_RECRUITING

Wayne State University/Karmanos Cancer Institute, Detroit

48236

ACTIVE_NOT_RECRUITING

Henry Ford Health Saint John Hospital, Detroit

48823

SUSPENDED

Michigan State University, East Lansing

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

RECRUITING

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

65212

RECRUITING

University of Missouri Children's Hospital, Columbia

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

70121

RECRUITING

Ochsner Medical Center Jefferson, New Orleans

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

75230

ACTIVE_NOT_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

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

80218

RECRUITING

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

83712

RECRUITING

Saint Luke's Cancer Institute - Boise, Boise

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

85016

RECRUITING

Phoenix Childrens Hospital, Phoenix

87106

RECRUITING

University of New Mexico Cancer Center, Albuquerque

89102

RECRUITING

University Medical Center of Southern Nevada, Las Vegas

89109

RECRUITING

Sunrise Hospital and Medical Center, Las Vegas

89135

RECRUITING

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

89144

RECRUITING

Summerlin Hospital Medical Center, Las Vegas

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

90095

RECRUITING

Mattel Children's Hospital UCLA, Los Angeles

90242

RECRUITING

Kaiser Permanente Downey Medical Center, Downey

92123

RECRUITING

Rady Children's Hospital - San Diego, San Diego

92134

RECRUITING

Naval Medical Center -San Diego, San Diego

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

94611

RECRUITING

Kaiser Permanente-Oakland, Oakland

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

98105

RECRUITING

Seattle Children's Hospital, Seattle

98405

RECRUITING

Mary Bridge Children's Hospital and Health Center, Tacoma

98431

RECRUITING

Madigan Army Medical 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

20889-5600

RECRUITING

Walter Reed National Military Medical Center, Bethesda

02111

ACTIVE_NOT_RECRUITING

Tufts Children's Hospital, Boston

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

07112

RECRUITING

Newark Beth Israel Medical Center, Newark

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

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

K7L 2V7

SUSPENDED

Kingston Health Sciences Centre, Kingston

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

00726

ACTIVE_NOT_RECRUITING

HIMA San Pablo Oncologic Hospital, Caguas

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK