Actively Recruiting
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-14
478
Participants Needed
177
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.
CONDITIONS
Official Title
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be enrolled on APEC14B1 and consent to Molecular Characterization Initiative testing before this study
- Age 30 years or younger at initial diagnosis with high-risk neuroblastoma
- Diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) confirmed by tumor pathology or bone marrow tumor cells with elevated urinary catecholamines
- Newly diagnosed high-risk neuroblastoma defined by INRG stage and MYCN amplification or age and stage criteria as specified
- Body surface area of at least 0.25 m^2
- No prior anti-cancer therapy except emergency treatment or one cycle of chemotherapy for low/intermediate risk disease
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Kidney function with serum creatinine or GFR meeting specified age/sex thresholds
- Total bilirubin less than or equal to 1.5 times the upper limit of normal for age
- Alanine aminotransferase (ALT) less than or equal to 10 times the upper limit of normal
- Heart function with shortening fraction of at least 27% or ejection fraction of at least 50%
- Ability to tolerate peripheral blood stem cell collection without contraindications
- Signed informed consent and compliance with all institutional, FDA, and NCI human study requirements
You will not qualify if you...
- Patients aged 365 to 546 days with INRG stage M and MYCN non-amplified neuroblastoma
- Patients 547 days or older with INRG stage L2 and MYCN non-amplified neuroblastoma
- Known bone marrow failure syndromes
- Use of chronic immunosuppressive medications except for allergic reactions or adrenal replacement (topical and inhaled corticosteroids allowed)
- Primary immunodeficiency requiring ongoing immune globulin replacement
- Pregnant females
- Lactating females planning to breastfeed
- Sexually active patients of reproductive potential not agreeing to effective contraception during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 177 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
Actively Recruiting
3
Banner Children's at Desert
Mesa, Arizona, United States, 85202
Actively Recruiting
4
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
5
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
6
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
7
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
8
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
9
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
10
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
11
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
12
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
13
Mattel Children's Hospital UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
14
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
15
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
16
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
17
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
18
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
19
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
Actively Recruiting
20
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
21
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
22
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
23
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
24
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
25
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
26
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
27
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
28
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
29
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
30
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
31
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
32
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
33
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
34
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
35
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
36
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
37
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
38
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
39
Saint Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
40
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
41
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
42
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
43
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Suspended
44
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
45
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
46
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
47
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Actively Recruiting
48
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
49
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
50
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
51
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
52
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
53
Wesley Medical Center
Wichita, Kansas, United States, 67214
Actively Recruiting
54
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
55
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
56
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
57
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Actively Recruiting
58
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
59
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
60
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
61
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
62
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Actively Recruiting
63
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
64
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
65
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
66
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
67
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
68
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
69
Corewell Health Children's
Royal Oak, Michigan, United States, 48073
Actively Recruiting
70
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
71
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
72
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
73
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
74
University of Missouri Children's Hospital
Columbia, Missouri, United States, 65212
Actively Recruiting
75
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
76
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
77
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
78
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
79
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
80
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
81
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
82
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
83
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
84
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
85
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
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
Suspended
88
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
89
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
90
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
91
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
92
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
93
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
94
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
95
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
96
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
97
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
98
Mission Hospital
Asheville, North Carolina, United States, 28801
Suspended
99
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
100
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
101
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
102
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
103
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
104
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
105
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
106
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
107
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Suspended
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
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
115
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
116
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
117
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
118
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
119
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
120
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Actively Recruiting
121
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
122
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
123
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
124
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
125
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
126
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
127
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
128
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
129
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
130
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
131
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
132
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
133
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
134
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
135
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
136
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
137
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
138
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
139
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Actively Recruiting
140
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States, 79415
Actively Recruiting
141
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
142
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
143
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
144
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
145
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
146
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
147
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Actively Recruiting
148
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
149
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
150
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
151
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
Actively Recruiting
152
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
153
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Suspended
154
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
155
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
156
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
157
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
158
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
159
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
160
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
161
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
162
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
163
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
164
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
165
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
166
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
167
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
168
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
169
Children's Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
170
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
171
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
172
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Actively Recruiting
173
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
174
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
175
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
176
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1V 4G2
Actively Recruiting
177
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1145
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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