Taking people in United StatesPhase 3

Adds dinutuximab to standard treatment for children with high-risk neuroblastoma

Tests adding dinutuximab to chemotherapy in children with newly diagnosed high-risk neuroblastoma.

Plain-language title generated from the registry record
Registry title: Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

Key facts

Where: Akron, Albany, Albuquerque, Allentown, Ann Arbor, Asheville, Atlanta, Aurora, Austin, Baltimore, Bangor, Bethesda, Birmingham, Boston, Buffalo, Burlington, Chapel Hill, Charleston, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Corpus Christi, Dallas, Danville, Dayton, Des Moines, Detroit, Downey, Duarte, Durham, El Paso, Fargo, Fort Lauderdale, Fort Myers, Fort Worth, Gainesville, Grand Rapids, Green Bay, Greenville, Hackensack, Hartford, Hollywood, Honolulu, Houston, Huntington, Indianapolis, Iowa City, Jackson, Jacksonville, Kalamazoo, Kansas City, Knoxville, Las Vegas, Lebanon, Lexington, Little Rock, Loma Linda, Long Beach, Los Angeles, Louisville, Lubbock, Madera, Madison, Marshfield, Memphis, Mesa, Miami, Milwaukee, Mineola, Minneapolis, Mobile, Morgantown, Morristown, Nashville, New Brunswick, New Haven, New Hyde Park, New Orleans, New York, Newark, Oak Lawn, Oakland, Oklahoma City, Omaha, Orange, Orlando, Palo Alto, Park Ridge, Paterson, Peoria, Philadelphia, Phoenix, Pittsburgh, Portland, Portsmouth, Providence, Rochester, Royal Oak, Sacramento, Salt Lake City, San Antonio, San Diego, San Francisco, Savannah, Scarborough, Seattle, Sioux Falls, Spokane, Springfield, St Louis, St. Petersburg, Syracuse, Tacoma, The Bronx, Toledo, Tucson, Tulsa, Valhalla, Washington D.C., West Palm Beach, Wichita, Wilmington, and Winston-Salem, United StatesSee the 158 sites
Phase: Phase 3

Where in United States

Children's Hospital Medical Center of AkronAkron, United StatesTaking people
Albany Medical CenterAlbany, United StatesTaking people
University of New Mexico Cancer CenterAlbuquerque, United StatesNo longer taking part
Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
C S Mott Children's HospitalAnn Arbor, United StatesTaking people
Mission HospitalAsheville, United StatesTaking people
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesTaking people
Children's Hospital ColoradoAurora, United StatesTaking people
Dell Children's Medical Center of Central TexasAustin, United StatesTaking people
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, United StatesTaking people
Sinai Hospital of BaltimoreBaltimore, United StatesTaking people
University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesTaking people
Eastern Maine Medical CenterBangor, United StatesTaking people
Walter Reed National Military Medical CenterBethesda, United StatesTaking people
Children's Hospital of AlabamaBirmingham, United StatesTaking people
Dana-Farber Cancer InstituteBoston, United StatesTaking people
Massachusetts General Hospital Cancer CenterBoston, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesTaking people
University of Vermont and State Agricultural CollegeBurlington, United StatesTaking people
UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
Medical University of South CarolinaCharleston, United StatesTaking people
Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesTaking people
Novant Health Presbyterian Medical CenterCharlotte, United StatesTaking people
University of Virginia Cancer CenterCharlottesville, United StatesTaking people
Lurie Children's Hospital-ChicagoChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
University of IllinoisChicago, United StatesTaking people
Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
Cleveland Clinic FoundationCleveland, United StatesTaking people
Rainbow Babies and Childrens HospitalCleveland, United StatesTaking people
Prisma Health Richland HospitalColumbia, United StatesTaking people
University of Missouri Children's HospitalColumbia, United StatesTaking people
Nationwide Children's HospitalColumbus, United StatesTaking people
Driscoll Children's HospitalCorpus Christi, United StatesTaking people
Medical City Dallas HospitalDallas, United StatesTaking people
UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
Geisinger Medical CenterDanville, United StatesTaking people
Dayton Children's HospitalDayton, United StatesTaking people
Blank Children's HospitalDes Moines, United StatesTaking people
Children's Hospital of MichiganDetroit, United StatesNo longer taking part
Kaiser Permanente Downey Medical CenterDowney, United StatesTaking people
City of Hope Comprehensive Cancer CenterDuarte, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
El Paso Children's HospitalEl Paso, United StatesTaking people
Sanford Broadway Medical CenterFargo, United StatesTaking people
Broward Health Medical CenterFort Lauderdale, United StatesTaking people
Golisano Children's Hospital of Southwest FloridaFort Myers, United StatesTaking people
Cook Children's Medical CenterFort Worth, United StatesTaking people
UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesTaking people
Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesNo longer taking part
BI-LO Charities Children's Cancer CenterGreenville, United StatesTaking people
East Carolina UniversityGreenville, United StatesTaking people
Hackensack University Medical CenterHackensack, United StatesTaking people
Connecticut Children's Medical CenterHartford, United StatesTaking people
Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesTaking people
Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesTaking people
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
UT MD Anderson Cancer CenterHouston, United StatesTaking people
Edwards Comprehensive Cancer CenterHuntington, United StatesTaking people
Ascension Saint Vincent Indianapolis HospitalIndianapolis, United StatesTaking people
Riley Hospital for ChildrenIndianapolis, United StatesTaking people
University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
University of Mississippi Medical CenterJackson, United StatesTaking people
Nemours Children's Clinic-JacksonvilleJacksonville, United StatesTaking people
Bronson Methodist HospitalKalamazoo, United StatesTaking people
Children's Mercy Hospitals and ClinicsKansas City, United StatesTaking people
East Tennessee Childrens HospitalKnoxville, United StatesTaking people
Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
Arkansas Children's HospitalLittle Rock, United StatesTaking people
Loma Linda University Medical CenterLoma Linda, United StatesTaking people
Miller Children's and Women's Hospital Long BeachLong Beach, United StatesTaking people
Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
Children's Hospital Los AngelesLos Angeles, United StatesTaking people
Mattel Children's Hospital UCLALos Angeles, United StatesTaking people
Norton Children's HospitalLouisville, United StatesTaking people
Covenant Children's HospitalLubbock, United StatesTaking people
UMC Cancer Center / UMC Health SystemLubbock, United StatesTaking people
Valley Children's HospitalMadera, United StatesTaking people
University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
Saint Jude Children's Research HospitalMemphis, United StatesTaking people
Banner Children's at DesertMesa, United StatesTaking people
Nicklaus Children's HospitalMiami, United StatesTaking people
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
Children's Hospital of WisconsinMilwaukee, United StatesTaking people
NYU Langone Hospital - Long IslandMineola, United StatesTaking people
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, United StatesTaking people
University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesTaking people
USA Health Strada Patient Care CenterMobile, United StatesTaking people
West Virginia University HealthcareMorgantown, United StatesTaking people
Morristown Medical CenterMorristown, United StatesTaking people
The Children's Hospital at TriStar CentennialNashville, United StatesTaking people
Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew Brunswick, United StatesTaking people
Saint Peter's University HospitalNew Brunswick, United StatesTaking people
Yale UniversityNew Haven, United StatesTaking people
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, United StatesTaking people
Children's Hospital New OrleansNew Orleans, United StatesTaking people
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesTaking people
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesTaking people
Newark Beth Israel Medical CenterNewark, United StatesTaking people
Advocate Children's Hospital-Oak LawnOak Lawn, United StatesTaking people
Kaiser Permanente-OaklandOakland, United StatesTaking people
UCSF Benioff Children's Hospital OaklandOakland, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Children's Hospital and Medical Center of OmahaOmaha, United StatesTaking people
University of Nebraska Medical CenterOmaha, United StatesTaking people
Children's Hospital of Orange CountyOrange, United StatesTaking people
AdventHealth OrlandoOrlando, United StatesTaking people
Arnold Palmer Hospital for ChildrenOrlando, United StatesTaking people
Nemours Children's HospitalOrlando, United StatesTaking people
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, United StatesTaking people
Advocate Children's Hospital-Park RidgePark Ridge, United StatesTaking people
Saint Joseph's Regional Medical CenterPaterson, United StatesTaking people
OSF Children's Hospital of IllinoisPeoria, United StatesTaking people
Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
Saint Christopher's Hospital for ChildrenPhiladelphia, United StatesTaking people
Phoenix Childrens HospitalPhoenix, United StatesTaking people
Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesTaking people
Legacy Emanuel Children's HospitalPortland, United StatesTaking people
Oregon Health and Science UniversityPortland, United StatesTaking people
Naval Medical Center - PortsmouthPortsmouth, United StatesTaking people
Rhode Island HospitalProvidence, United StatesTaking people
Mayo Clinic in RochesterRochester, United StatesTaking people
University of RochesterRochester, United StatesTaking people
Corewell Health Children'sRoyal Oak, United StatesTaking people
Sutter Medical Center SacramentoSacramento, United StatesTaking people
University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
Primary Children's HospitalSalt Lake City, United StatesTaking people
Children's Hospital of San AntonioSan Antonio, United StatesTaking people
Methodist Children's Hospital of South TexasSan Antonio, United StatesTaking people
University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
Rady Children's Hospital - San DiegoSan Diego, United StatesTaking people
UCSF Medical Center-Mission BaySan Francisco, United StatesTaking people
Memorial Health University Medical CenterSavannah, United StatesTaking people
Maine Children's Cancer ProgramScarborough, United StatesTaking people
Seattle Children's HospitalSeattle, United StatesTaking people
Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
Providence Sacred Heart Medical Center and Children's HospitalSpokane, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Mercy Hospital Saint LouisSt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Johns Hopkins All Children's HospitalSt. Petersburg, United StatesTaking people
State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
Mary Bridge Children's Hospital and Health CenterTacoma, United StatesTaking people
Montefiore Medical Center - Moses CampusThe Bronx, United StatesTaking people
ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, United StatesTaking people
Banner University Medical Center - TucsonTucson, United StatesTaking people
Saint Francis Children's HospitalTulsa, United StatesTaking people
New York Medical CollegeValhalla, United StatesTaking people
Children's National Medical CenterWashington D.C., United StatesTaking people
Saint Mary's Medical CenterWest Palm Beach, United StatesTaking people
Wesley Medical CenterWichita, United StatesTaking people
Alfred I duPont Hospital for ChildrenWilmington, United StatesTaking people
Wake Forest University Health SciencesWinston-Salem, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Print a page for my doctor

Trial details

Who runs it: National Cancer Institute (NCI)
Trial code: NCT06172296
Record updated: 30 October 2026
Original description: 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.Read full original descriptionShow less
A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma
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.
Inclusion: Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131; ≤ 30 years at the time of initial diagnosis with high-risk disease; * Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines; Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:; Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification; Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment); Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy; Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment); Patients must have a body surface area (BSA) ≥ 0.25 m\^2; No prior anti-cancer therapy except as outlined below:; Patients initially recognized to have high-risk disease treated with topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing, and with consent; Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria; Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis; Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; A serum creatinine based on age/sex as follows:; 1 month to < 6 months: Male 0.4 mg/dL and female 0.4mg/dL; 6 months to < 1 year: Male 0.5 mg/dL and female 0.5 mg/dL; 1 to < 2 years: Male 0.6 mg/dL and female 0.6 mg/dL; 2 to < 6 years: Male 0.8 mg/dL and female 0.8 mg/dL; 6 to < 10 years: Male 1 mg/dL and female 1 mg/dL; 10 to < 13 years: Male 1.2 mg/dL and female 1.2 mg/dL; 13 to < 16 years: Male 1.5 mg/dL and female 1.4 mg/dL; ≥ 16 years: Male 1.7 mg/dL and female 1.4 mg/dL; The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC); or a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 or; or a GFR ≥ 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard); Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility; Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase [ALT]) ≤ 10 x ULN*; Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L; * Shortening fraction of ≥ 27% by echocardiogram, or; Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram; Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:; No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.
Exclusion: Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential; Patients with known bone marrow failure syndromes; Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable; Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy; All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met; Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features; Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features; Lactating females who plan to breastfeed their infants; Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; All patients and/or their parents or legal guardians must sign a written informed consent.
ClinicalTrials.gov NCT06172296