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

ClinicalTrials.gov ID: NCT03126916

Public ClinicalTrials.gov record NCT03126916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 5, 2026, 7:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Study identification

NCT ID: NCT03126916
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Children's Oncology Group; Network
Enrollment: 750 participants

Conditions and interventions

Conditions

Interventions

Autologous Hematopoietic Stem Cell Transplantation Procedure
Biospecimen Collection Procedure
Bone Marrow Aspiration and Biopsy Procedure
Busulfan Drug
Carboplatin Drug
Cisplatin Drug
Computed Tomography Procedure
Cyclophosphamide Drug
Dexrazoxane Hydrochloride Drug
Dinutuximab Biological
Doxorubicin Hydrochloride Drug
Echocardiography Test Procedure
Etoposide Phosphate Drug
External Beam Radiation Therapy Radiation
Iobenguane I-123 Radiation
Iobenguane I-131 Radiation
Isotretinoin Drug
Lorlatinib Drug
Magnetic Resonance Imaging Procedure
Melphalan Hydrochloride Drug
Multigated Acquisition Scan Procedure
Positron Emission Tomography Procedure
Sargramostim Biological
Therapeutic Conventional Surgery Procedure
Thiotepa Drug
Topotecan Hydrochloride Drug
Vincristine Sulfate Drug

Procedure · Drug · Biological + 1 more

Eligibility (public fields only)

Age range: 365 Days to 30 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 13, 2018
Primary completion: Sep 29, 2030
Completion: Sep 29, 2030
Last update posted: Feb 26, 2026

2018 – 2030

United States locations

U.S. sites: 152
U.S. states: 47
U.S. cities: 124

Facility	City	State	ZIP	Site status
Children's Hospital of Alabama	Birmingham	Alabama	35233	Recruiting
Phoenix Childrens Hospital	Phoenix	Arizona	85016	Recruiting
Arkansas Children's Hospital	Little Rock	Arkansas	72202-3591	Recruiting
Kaiser Permanente Downey Medical Center	Downey	California	90242	Recruiting
Loma Linda University Medical Center	Loma Linda	California	92354	Recruiting
Children's Hospital Los Angeles	Los Angeles	California	90027	Recruiting
Mattel Children's Hospital UCLA	Los Angeles	California	90095	Recruiting
Valley Children's Hospital	Madera	California	93636	Recruiting
Kaiser Permanente-Oakland	Oakland	California	94611	Recruiting
Children's Hospital of Orange County	Orange	California	92868	Recruiting
Lucile Packard Children's Hospital Stanford University	Palo Alto	California	94304	Recruiting
University of California Davis Comprehensive Cancer Center	Sacramento	California	95817	Recruiting
Rady Children's Hospital - San Diego	San Diego	California	92123	Recruiting
Naval Medical Center -San Diego	San Diego	California	92134	Recruiting
UCSF Medical Center-Mission Bay	San Francisco	California	94158	Recruiting
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center	Denver	Colorado	80218	Recruiting
Connecticut Children's Medical Center	Hartford	Connecticut	06106	Recruiting
Yale University	New Haven	Connecticut	06520	Recruiting
Alfred I duPont Hospital for Children	Wilmington	Delaware	19803	Recruiting
Children's National Medical Center	Washington D.C.	District of Columbia	20010	Recruiting
Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida	33908	Recruiting
UF Health Cancer Institute - Gainesville	Gainesville	Florida	32610	Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida	33021	Recruiting
Nemours Children's Clinic-Jacksonville	Jacksonville	Florida	32207	Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	33136	Recruiting
Nicklaus Children's Hospital	Miami	Florida	33155	Recruiting
AdventHealth Orlando	Orlando	Florida	32803	Recruiting
Nemours Children's Hospital	Orlando	Florida	32827	Recruiting
Johns Hopkins All Children's Hospital	St. Petersburg	Florida	33701	Recruiting
Saint Mary's Medical Center	West Palm Beach	Florida	33407	Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital	Atlanta	Georgia	30329	Recruiting
Memorial Health University Medical Center	Savannah	Georgia	31404	Recruiting
Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	96826	Recruiting
Saint Luke's Cancer Institute - Boise	Boise	Idaho	83712	Recruiting
Lurie Children's Hospital-Chicago	Chicago	Illinois	60611	Recruiting
University of Illinois	Chicago	Illinois	60612	Recruiting
University of Chicago Comprehensive Cancer Center	Chicago	Illinois	60637	Recruiting
Advocate Children's Hospital-Oak Lawn	Oak Lawn	Illinois	60453	Recruiting
Advocate Children's Hospital-Park Ridge	Park Ridge	Illinois	60068	Recruiting
Saint Jude Midwest Affiliate	Peoria	Illinois	61637	Recruiting
Southern Illinois University School of Medicine	Springfield	Illinois	62702	Recruiting
Riley Hospital for Children	Indianapolis	Indiana	46202	Recruiting
Blank Children's Hospital	Des Moines	Iowa	50309	Recruiting
University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	52242	Recruiting
University of Kentucky/Markey Cancer Center	Lexington	Kentucky	40536	Recruiting
Children's Hospital New Orleans	New Orleans	Louisiana	70118	Recruiting
Ochsner Medical Center Jefferson	New Orleans	Louisiana	70121	Recruiting
Eastern Maine Medical Center	Bangor	Maine	04401	Recruiting
Maine Children's Cancer Program	Scarborough	Maine	04074	Recruiting
University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	21201	Recruiting
Sinai Hospital of Baltimore	Baltimore	Maryland	21215	Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	21287	Recruiting
Walter Reed National Military Medical Center	Bethesda	Maryland	20889-5600	Recruiting
Tufts Children's Hospital	Boston	Massachusetts	02111	Active, not recruiting
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	02114	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
C S Mott Children's Hospital	Ann Arbor	Michigan	48109	Recruiting
Children's Hospital of Michigan	Detroit	Michigan	48201	Suspended
Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	48201	Active, not recruiting
Henry Ford Health Saint John Hospital	Detroit	Michigan	48236	Active, not recruiting
Michigan State University	East Lansing	Michigan	48823	Suspended
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital	Grand Rapids	Michigan	49503	Recruiting
Bronson Methodist Hospital	Kalamazoo	Michigan	49007	Recruiting
Corewell Health Children's	Royal Oak	Michigan	48073	Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota	55404	Recruiting
University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota	55455	Recruiting
Mayo Clinic in Rochester	Rochester	Minnesota	55905	Recruiting
University of Mississippi Medical Center	Jackson	Mississippi	39216	Recruiting
University of Missouri Children's Hospital	Columbia	Missouri	65212	Recruiting
Children's Mercy Hospitals and Clinics	Kansas City	Missouri	64108	Recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Recruiting
Mercy Hospital Saint Louis	St Louis	Missouri	63141	Recruiting
Children's Hospital and Medical Center of Omaha	Omaha	Nebraska	68114	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	68198	Recruiting
University Medical Center of Southern Nevada	Las Vegas	Nevada	89102	Recruiting
Sunrise Hospital and Medical Center	Las Vegas	Nevada	89109	Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada	89135	Recruiting
Summerlin Hospital Medical Center	Las Vegas	Nevada	89144	Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center	Lebanon	New Hampshire	03756	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Morristown Medical Center	Morristown	New Jersey	07960	Recruiting
Saint Peter's University Hospital	New Brunswick	New Jersey	08901	Recruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital	New Brunswick	New Jersey	08903	Recruiting
Newark Beth Israel Medical Center	Newark	New Jersey	07112	Recruiting
Saint Joseph's Regional Medical Center	Paterson	New Jersey	07503	Recruiting
University of New Mexico Cancer Center	Albuquerque	New Mexico	87106	Recruiting
Albany Medical Center	Albany	New York	12208	Recruiting
Maimonides Medical Center	Brooklyn	New York	11219	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	14263	Recruiting
NYU Langone Hospital - Long Island	Mineola	New York	11501	Recruiting
The Steven and Alexandra Cohen Children's Medical Center of New York	New Hyde Park	New York	11040	Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York	10016	Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	10032	Recruiting
University of Rochester	Rochester	New York	14642	Recruiting
Stony Brook University Medical Center	Stony Brook	New York	11794	Recruiting
State University of New York Upstate Medical University	Syracuse	New York	13210	Recruiting
Montefiore Medical Center - Moses Campus	The Bronx	New York	10467	Recruiting
New York Medical College	Valhalla	New York	10595	Recruiting
Mission Hospital	Asheville	North Carolina	28801	Recruiting
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	27599	Recruiting
Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	28203	Recruiting
Duke University Medical Center	Durham	North Carolina	27710	Recruiting
East Carolina University	Greenville	North Carolina	27834	Recruiting
Wake Forest University Health Sciences	Winston-Salem	North Carolina	27157	Recruiting
Sanford Broadway Medical Center	Fargo	North Dakota	58122	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Rainbow Babies and Childrens Hospital	Cleveland	Ohio	44106	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	43205	Recruiting
Dayton Children's Hospital	Dayton	Ohio	45404	Recruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital	Toledo	Ohio	43606	Recruiting
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	Recruiting
Legacy Emanuel Children's Hospital	Portland	Oregon	97227	Recruiting
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	18103	Recruiting
Geisinger Medical Center	Danville	Pennsylvania	17822	Recruiting
Penn State Children's Hospital	Hershey	Pennsylvania	17033	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	15224	Recruiting
Rhode Island Hospital	Providence	Rhode Island	02903	Recruiting
Medical University of South Carolina	Charleston	South Carolina	29425	Recruiting
Prisma Health Richland Hospital	Columbia	South Carolina	29203	Recruiting
BI-LO Charities Children's Cancer Center	Greenville	South Carolina	29605	Recruiting
Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	57117-5134	Recruiting
East Tennessee Childrens Hospital	Knoxville	Tennessee	37916	Recruiting
Saint Jude Children's Research Hospital	Memphis	Tennessee	38105	Recruiting
The Children's Hospital at TriStar Centennial	Nashville	Tennessee	37203	Recruiting
Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	37232	Recruiting
Dell Children's Medical Center of Central Texas	Austin	Texas	78723	Recruiting
Driscoll Children's Hospital	Corpus Christi	Texas	78411	Recruiting
Medical City Dallas Hospital	Dallas	Texas	75230	Active, not recruiting
UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	75390	Recruiting
El Paso Children's Hospital	El Paso	Texas	79905	Recruiting
Cook Children's Medical Center	Fort Worth	Texas	76104	Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	77030	Recruiting
Covenant Children's Hospital	Lubbock	Texas	79410	Recruiting
UMC Cancer Center / UMC Health System	Lubbock	Texas	79415	Recruiting
Children's Hospital of San Antonio	San Antonio	Texas	78207	Recruiting
Methodist Children's Hospital of South Texas	San Antonio	Texas	78229	Recruiting
University of Texas Health Science Center at San Antonio	San Antonio	Texas	78229	Recruiting
Primary Children's Hospital	Salt Lake City	Utah	84113	Recruiting
University of Vermont and State Agricultural College	Burlington	Vermont	05405	Recruiting
VCU Massey Comprehensive Cancer Center	Richmond	Virginia	23298	Active, not recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting
Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	99204	Recruiting
Mary Bridge Children's Hospital and Health Center	Tacoma	Washington	98405	Recruiting
Madigan Army Medical Center	Tacoma	Washington	98431	Recruiting
West Virginia University Healthcare	Morgantown	West Virginia	26506	Recruiting
Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin	54301	Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital	Madison	Wisconsin	53792	Recruiting
Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	54449	Recruiting
Children's Hospital of Wisconsin	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03126916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 26, 2026 · Synced May 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03126916 live on ClinicalTrials.gov.

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