Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

February 12, 2013

Primary Completion Date

June 30, 2018

Study Completion Date

September 30, 2022

Conditions
GanglioneuroblastomaRecurrent Neuroblastoma
Interventions
BIOLOGICAL

Dinutuximab

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

BIOLOGICAL

Sargramostim

Given SC or IV

DRUG

Temozolomide

Given PO

DRUG

Temsirolimus

Given IV

Trial Locations (157)

1145

Starship Children's Hospital, Grafton

2031

Sydney Children's Hospital, Randwick

2145

The Children's Hospital at Westmead, Westmead

4029

Royal Children's Hospital-Brisbane, Herston

4101

Queensland Children's Hospital, South Brisbane

6008

Princess Margaret Hospital for Children, 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

10595

New York Medical College, Valhalla

11040

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

11501

NYU Winthrop Hospital, 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

19104

Children's Hospital of Philadelphia, Philadelphia

19134

Saint Christopher's Hospital for Children, 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.

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

23507

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

26506

West Virginia University Healthcare, Morgantown

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University Medical Center, Durham

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28801

Mission Hospital, Asheville

29203

Prisma Health Richland Hospital, Columbia

29605

BI-LO Charities Children's Cancer Center, Greenville

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

31404

Memorial Health University Medical Center, Savannah

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32504

Nemours Children's Clinic - Pensacola, Pensacola

32610

University of Florida Health Science Center - Gainesville, Gainesville

32803

AdventHealth Orlando, Orlando

32806

Nemours Children's Clinic - Orlando, 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 Hospital, West Palm Beach

33607

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa

33701

Johns Hopkins All Children's Hospital, St. Petersburg

33901

Lee Memorial Health System, Fort Myers

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

37916

East Tennessee Childrens Hospital, Knoxville

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

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

Wayne State University/Karmanos Cancer Institute, Detroit

48236

Ascension Saint John Hospital, Detroit

49503

Helen DeVos Children's Hospital at Spectrum Health, 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, Madison

54449

Marshfield Medical Center-Marshfield, Marshfield

55404

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

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

55905

Mayo Clinic in Rochester, Rochester

58122

Sanford Broadway Medical Center, Fargo

60153

Loyola University Medical Center, Maywood

60453

Advocate Children's Hospital-Oak Lawn, Oak Lawn

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

62702

Southern Illinois University School of Medicine, Springfield

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

72205

University of Arkansas for Medical Sciences, Little Rock

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

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

85016

Phoenix Childrens Hospital, Phoenix

87102

University of New Mexico Cancer Center, Albuquerque

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

89169

Nevada Cancer Research Foundation NCORP, Las Vegas

90027

Children's Hospital Los Angeles, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

92123

Rady Children's Hospital - San Diego, San Diego

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

93636

Valley Children's Hospital, Madera

94143

UCSF Medical Center-Parnassus, San Francisco

94158

UCSF Medical Center-Mission Bay, San Francisco

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94611

Kaiser Permanente-Oakland, Oakland

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96813

University of Hawaii Cancer Center, Honolulu

96826

Kapiolani Medical Center for Women and Children, Honolulu

97227

Legacy Emanuel Children's Hospital, Portland

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

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

02215

Dana-Farber Cancer Institute, Boston

48824-7016

Michigan State University Clinical Center, East Lansing

03756

Dartmouth Hitchcock Medical Center, Lebanon

07601

Hackensack University Medical Center, Hackensack

07960

Morristown Medical Center, Morristown

08903

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

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05405

University of Vermont and State Agricultural College, Burlington

T3B 6A8

Alberta Children's Hospital, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

V6H 3V4

British Columbia Children's Hospital, Vancouver

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

N6A 5W9

Children's Hospital, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

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

G1V 4G2

Centre Hospitalier Universitaire de Quebec, Québec

00912

San Jorge Children's Hospital, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

United Therapeutics

INDUSTRY

lead

National Cancer Institute (NCI)

NIH