Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

PHASE1CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 9, 2013

Primary Completion Date

July 28, 2015

Study Completion Date

June 30, 2024

Conditions
GanglioneuroblastomaStage 1 NeuroblastomaStage 2 NeuroblastomaStage 2A NeuroblastomaStage 2B NeuroblastomaStage 3 NeuroblastomaStage 4 NeuroblastomaStage 4S Neuroblastoma
Interventions
PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous peripheral blood stem cell transplant

DRUG

Busulfan

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

BIOLOGICAL

Filgrastim

Given SC or IV

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

DRUG

Melphalan

Given IV

DRUG

Mesna

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo autologous peripheral blood stem cell transplant

OTHER

Pharmacological Study

Correlative studies

DRUG

Topotecan Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

Trial Locations (123)

1145

Starship Children's Hospital, Grafton

6008

Princess Margaret Hospital for Children, Perth

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

13210

State University of New York Upstate Medical University, Syracuse

14642

University of Rochester, Rochester

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

18017

Lehigh Valley Hospital - Muhlenberg, Bethlehem

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.

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University Medical Center, Durham

28801

Mission Hospital, Asheville

29203

Prisma Health Richland Hospital, Columbia

29425

Medical University of South Carolina, Charleston

29605

BI-LO Charities Children's Cancer Center, Greenville

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

30912

Augusta University Medical Center, Augusta

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

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

33176

Miami Cancer Institute, Miami

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

35233

Children's Hospital of Alabama, Birmingham

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37403

T C Thompson Children's Hospital, Chattanooga

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

43608

Mercy Children's Hospital, Toledo

44106

Rainbow Babies and Childrens Hospital, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

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

49007

Bronson Methodist Hospital, Kalamazoo

50309

Blank Children's Hospital, Des Moines

53792

University of Wisconsin Carbone Cancer Center - University Hospital, 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

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

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

65201

Columbia Regional, Columbia

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

73104

University of Oklahoma Health Sciences Center, Oklahoma City

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

78229

Methodist Children's Hospital of South Texas, San Antonio

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

80045

Children's Hospital Colorado, Aurora

87106

University of New Mexico Cancer Center, Albuquerque

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

91010

City of Hope Comprehensive Cancer Center, Duarte

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

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

94609

UCSF Benioff Children's Hospital Oakland, Oakland

94611

Kaiser Permanente-Oakland, Oakland

95817

University of California Davis Comprehensive Cancer Center, Sacramento

98105

Seattle Children's Hospital, Seattle

99204

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

06106

Connecticut Children's Medical Center, Hartford

04074

Maine Children's Cancer Program, Scarborough

20889-5600

Walter Reed National Military Medical Center, Bethesda

02111

Tufts Children's Hospital, Boston

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Dana-Farber Cancer Institute, Boston

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07601

Hackensack University Medical Center, Hackensack

07039

Saint Barnabas Medical Center, Livingston

07960

Morristown Medical Center, Morristown

08903

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

07112

Newark Beth Israel Medical Center, Newark

07503

Saint Joseph's Regional Medical Center, Paterson

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

V6H 3V4

British Columbia Children's Hospital, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

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

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

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT01798004 - Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma | Biotech Hunter | Biotech Hunter