Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

July 8, 2019

Primary Completion Date

March 31, 2025

Study Completion Date

April 7, 2026

Conditions
High Risk NeuroblastomaRecurrent NeuroblastomaRefractory Neuroblastoma
Interventions
BIOLOGICAL

Dinutuximab

Given IV

DRUG

Eflornithine Hydrochloride

Given PO or via NG or G tube

DRUG

Irinotecan Hydrochloride

Given IV

BIOLOGICAL

Sargramostim

Given SC or IV

DRUG

Temozolomide

Given PO or via NG or G tube

Trial Locations (146)

1145

Starship Children's Hospital, Grafton

2031

Sydney Children's Hospital, Randwick

2145

The Children's Hospital at Westmead, Westmead

2310

John Hunter Children's Hospital, Hunter Regional Mail Centre

3052

Royal Children's Hospital, Parkville

4101

Queensland Children's Hospital, South Brisbane

5006

Women's and Children's Hospital-Adelaide, North Adelaide

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

11040

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

11501

NYU Langone Hospital - Long Island, Mineola

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Penn State Children's Hospital, Hershey

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20007

MedStar Georgetown University Hospital, Washington D.C.

20010

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

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

23507

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

26506

West Virginia University Healthcare, Morgantown

27157

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Medical Center, Durham

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

29203

Prisma Health Richland Hospital, Columbia

29605

BI-LO Charities Children's Cancer Center, Greenville

30329

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

31404

Memorial Health University Medical Center, Savannah

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32806

Arnold Palmer Hospital for Children, Orlando

32827

Nemours Children's Hospital, Orlando

33021

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

33136

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

33155

Nicklaus Children's Hospital, Miami

33407

Saint Mary's Medical Center, West Palm Beach

33701

Johns Hopkins All Children's Hospital, St. Petersburg

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

Children's Hospital of Alabama, Birmingham

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37916

East Tennessee Childrens Hospital, Knoxville

38105

Saint Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

40536

University of Kentucky/Markey Cancer Center, Lexington

43205

Nationwide Children's Hospital, Columbus

43606

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

44106

Rainbow Babies and Childrens Hospital, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Riley Hospital for Children, Indianapolis

46260

Ascension Saint Vincent Indianapolis Hospital, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48201

Children's Hospital of Michigan, Detroit

Wayne State University/Karmanos Cancer Institute, Detroit

48824

Michigan State University Clinical Center, East Lansing

49007

Bronson Methodist Hospital, Kalamazoo

49503

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

50309

Blank Children's Hospital, Des Moines

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

Children's Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

55404

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

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

60153

Loyola University Medical Center, Maywood

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

70118

Children's Hospital New Orleans, New Orleans

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

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

78411

Driscoll Children's Hospital, Corpus Christi

78723

Dell Children's Medical Center of Central Texas, Austin

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

89102

University Medical Center of Southern Nevada, Las Vegas

89109

Sunrise Hospital and Medical Center, Las Vegas

89135

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

89144

Summerlin Hospital Medical Center, Las Vegas

89502

Renown Regional Medical Center, Reno

90027

Children's Hospital Los Angeles, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

90806

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

92123

Rady Children's Hospital - San Diego, San Diego

92868

Children's Hospital of Orange County, Orange

93636

Valley Children's Hospital, Madera

94158

UCSF Medical Center-Mission Bay, San Francisco

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94611

Kaiser Permanente-Oakland, Oakland

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96826

Kapiolani Medical Center for Women and Children, Honolulu

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

98405

Mary Bridge Children's Hospital and Health Center, Tacoma

98431

Madigan Army Medical Center, Tacoma

99204

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

72202-3591

Arkansas Children's Hospital, Little Rock

06106

Connecticut Children's Medical Center, Hartford

06520

Yale University, New Haven

04401

Eastern Maine Medical Center, Bangor

04074

Maine Children's Cancer Program, Scarborough

02215

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

07960

Morristown Medical Center, Morristown

02903

Rhode Island Hospital, Providence

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05405

University of Vermont and State Agricultural College, Burlington

R3E 0V9

CancerCare Manitoba, Winnipeg

A1B 3V6

Janeway Child Health Centre, St. John's

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

K7L 2V7

Kingston Health Sciences Centre, Kingston

N6A 5W9

Children's Hospital, London

M5G 1X8

Hospital for Sick Children, Toronto

H3H 1P3

The Montreal Children's Hospital of the MUHC, Montreal

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

G1V 4G2

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

00726

HIMA San Pablo Oncologic Hospital, Caguas

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK