Actively Recruiting
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Led by Children's Oncology Group ยท Updated on 2026-02-27
750
Participants Needed
162
Research Sites
646 weeks
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
CONDITIONS
Official Title
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 1 year and 30 years at diagnosis
- Diagnosis of neuroblastoma or nodular ganglioneuroblastoma confirmed by tumor pathology or bone marrow findings
- Patients with INRG stage M disease with MYCN amplification or age >547 days
- Patients with INRG stage MS disease with MYCN amplification
- Patients with INRG stage L2 disease with MYCN amplification
- Patients >547 days initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy and enroll within 4 weeks of progression
- Patients >=365 days initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy and enroll within 4 weeks of progression
- No prior systemic therapy except emergent topotecan/cyclophosphamide within allowed timing
- Creatinine clearance or GFR >= 70 mL/min/1.73 m2 or serum creatinine within age/sex limits
- Total bilirubin <= 1.5 x upper limit of normal for age
- ALT (SGPT) < 10 x upper limit of normal
- Shortening fraction >= 27% or ejection fraction > 50% by echocardiogram or radionuclide angiogram
- No known contraindications to peripheral blood stem cell collection
- For patients transferring from prior trial to Arm E: tumors with ALK aberration and age > 1 year at transfer
- No irreversible grade 2 or greater AV block
- No serious psychiatric disorder requiring pharmacologic intervention or life-threatening
You will not qualify if you...
- Patients with INRG stage L2 tumors without MYCN amplification
- Patients with bone marrow failure syndromes
- Patients contraindicated for targeted radiopharmaceutical therapy due to medical disorders
- Female patients who are pregnant
- Lactating females planning to breastfeed
- Sexually active patients of reproductive potential not agreeing to use effective contraception
- Patients previously treated with lorlatinib or other ALK inhibitors (for Arm E transfer patients)
- Patients who have started induction cycle 2 on prior trial (for Arm E transfer patients)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 162 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
4
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
5
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
6
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
7
Mattel Children's Hospital UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
8
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
9
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
10
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
11
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
12
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
13
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
14
Naval Medical Center -San Diego
San Diego, California, United States, 92134
Actively Recruiting
15
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
16
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
17
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
Actively Recruiting
18
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
19
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
20
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
21
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
22
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
23
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
24
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
25
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
26
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
27
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
28
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
29
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
30
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
31
Saint Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
32
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
33
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
34
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
35
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
36
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
37
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
38
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
39
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
40
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Actively Recruiting
41
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
42
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
43
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
44
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
45
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
46
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
47
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
48
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
49
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Actively Recruiting
50
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
51
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
52
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
53
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
54
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Actively Recruiting
55
Tufts Children's Hospital
Boston, Massachusetts, United States, 02111
Active, Not Recruiting
56
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
57
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
58
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
59
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Suspended
60
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Active, Not Recruiting
61
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States, 48236
Active, Not Recruiting
62
Michigan State University
East Lansing, Michigan, United States, 48823
Suspended
63
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
64
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
65
Corewell Health Children's
Royal Oak, Michigan, United States, 48073
Actively Recruiting
66
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
67
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
68
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
69
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
70
University of Missouri Children's Hospital
Columbia, Missouri, United States, 65212
Actively Recruiting
71
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
72
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
73
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
74
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
75
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
76
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
77
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
Actively Recruiting
78
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
79
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Actively Recruiting
80
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
81
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
82
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
83
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
84
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
85
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
86
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
87
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
88
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
89
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
90
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
91
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
92
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
93
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
94
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
95
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
96
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
97
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
98
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
99
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
100
Mission Hospital
Asheville, North Carolina, United States, 28801
Actively Recruiting
101
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
102
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
103
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
104
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
105
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
106
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
107
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
108
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
109
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
110
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
111
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
112
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
113
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
114
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
115
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
116
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
117
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
118
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
119
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
120
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
121
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
122
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
123
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
124
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
125
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
126
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
127
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
128
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
129
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
130
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
131
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Active, Not Recruiting
132
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
133
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
134
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
135
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
136
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Actively Recruiting
137
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States, 79415
Actively Recruiting
138
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
139
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
140
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
141
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
142
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
143
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Active, Not Recruiting
144
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
145
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
146
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
147
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Actively Recruiting
148
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
149
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
150
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
151
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
152
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
153
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Suspended
154
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Suspended
155
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Suspended
156
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Suspended
157
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Suspended
158
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Suspended
159
Children's Hospital
London, Ontario, Canada, N6A 5W9
Suspended
160
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Suspended
161
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Suspended
162
HIMA San Pablo Oncologic Hospital
Caguas, Puerto Rico, 00726
Active, Not Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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