Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

October 4, 2010

Primary Completion Date

September 28, 2016

Study Completion Date

September 28, 2025

Conditions
GanglioneuroblastomaLocalized Resectable NeuroblastomaLocalized Unresectable NeuroblastomaRegional NeuroblastomaStage 4 NeuroblastomaStage 4S Neuroblastoma
Interventions
RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo radiotherapy

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous in vitro-treated peripheral blood stem cell transplantation

DRUG

Busulfan

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide Phosphate

Given IV

RADIATION

External Beam Radiation Therapy

Undergo radiotherapy

PROCEDURE

In Vitro-Treated Peripheral Blood Stem Cell Transplantation

Undergo autologous in vitro-treated peripheral blood stem cell transplantation

RADIATION

Intensity-Modulated Radiation Therapy

Undergo radiotherapy

RADIATION

Iobenguane I-131

Given IV

DRUG

Isotretinoin

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan

Given IV

OTHER

Pharmacological Study

Correlative studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

DRUG

Topotecan Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

Trial Locations (25)

19104

Children's Hospital of Philadelphia, Philadelphia

20010

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

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30329

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

35233

Children's Hospital of Alabama, Birmingham

University of Alabama at Birmingham Cancer Center, Birmingham

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

48109

C S Mott Children's Hospital, Ann Arbor

53226

Children's Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

60637

University of Chicago Comprehensive Cancer Center, Chicago

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

94143

UCSF Medical Center-Parnassus, San Francisco

94158

UCSF Medical Center-Mission Bay, San Francisco

98105

Seattle Children's Hospital, Seattle

99204

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

06106

Connecticut Children's Medical Center, Hartford

02215

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK