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Study identifier: NCT06172296 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

Condition: Ganglioneuroblastoma, Nodular · Neuroblastoma  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 3
Planned participants478
Who can joinAll sexes, N/A to 30 Years
Healthy volunteersNo

About this study

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 trans…

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (178)

Children's Hospital of AlabamaBirmingham, Alabama, United StatesRecruiting
USA Health Strada Patient Care CenterMobile, Alabama, United StatesRecruiting
Banner Children's at DesertMesa, Arizona, United StatesRecruiting
Phoenix Childrens HospitalPhoenix, Arizona, United StatesRecruiting
Banner University Medical Center - TucsonTucson, Arizona, United StatesRecruiting
Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
Kaiser Permanente Downey Medical CenterDowney, California, United StatesRecruiting
City of Hope Comprehensive Cancer CenterDuarte, California, United StatesRecruiting
Loma Linda University Medical CenterLoma Linda, California, United StatesRecruiting
Miller Children's and Women's Hospital Long BeachLong Beach, California, United StatesRecruiting
Children's Hospital Los AngelesLos Angeles, California, United StatesRecruiting
Cedars-Sinai Medical CenterLos Angeles, California, United StatesRecruiting

+ 166 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06172296