NCT06172296 · National Cancer Institute (NCI)
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
What this study is about
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with the usual treatment surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma.
View original scientific 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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood and urine sample collection
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow biopsy
DRUG
Carboplatin
Given IV
DRUG
Cisplatin
Given IV
PROCEDURE
Computed Tomography
Undergo CT scan
DRUG
Cyclophosphamide
Given IV
BIOLOGICAL
Dinutuximab
Given IV
DRUG
Doxorubicin
Given IV
PROCEDURE
Echocardiography Test
Undergo ECHO
DRUG
Etoposide
Given IV
PROCEDURE
FDG-Positron Emission Tomography and Computed Tomography Scan
Undergo FDG PET
PROCEDURE
Hematopoietic Cell Transplantation
Undergo stem cell infusion
DRUG
Irinotecan
Given IV
DRUG
Isotretinoin
Given PO
PROCEDURE
Leukapheresis
Undergo apheresis
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
Melphalan
Given IV
PROCEDURE
Multigated Acquisition Scan
Undergo MUGA
RADIATION
Radiation Therapy
Undergo radiation therapy
PROCEDURE
Radionuclide Imaging
Undergo I-MIBG scan
OTHER
Survey Administration
Ancillary studies
DRUG
Temozolomide
Given PO or via NG or G tube
DRUG
Thiotepa
Given IV
DRUG
Topotecan
Given IV
PROCEDURE
Tumor Resection
Undergo tumor resection surgery
DRUG
Vincristine
Given IV
Primary outcome measures
Event free survival (EFS)
Time frame: Up to 3 years
EFS time is calculated from time of randomization to Arms A or B to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Birmingham, Alabama
- Mobile, Alabama
- Mesa, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Downey, California
- Duarte, California
- Loma Linda, California
- Long Beach, California
- Los Angeles, California
- Madera, California
And 117 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations