Recruiting

Dinutuximab and Intensive Therapy for High-Risk Neuroblastoma in Children

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate whether dinutuximab and intensive therapy improve survival outcomes in children with high-risk neuroblastoma.

What is being tested

Biospecimen Collection

+ Bone Marrow Aspiration

+ Bone Marrow Biopsy

ProcedureDrugBiologicalRadiationOther
Who is being recruted

Neoplasms+8

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

Until 30 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 19, 2024

Actual date on which the first participant was enrolled.

This study focuses on children who have been newly diagnosed with high-risk neuroblastoma, a type of cancer that develops from immature nerve cells. The goal is to find out if adding a drug called dinutuximab to the usual intense cancer treatments can help these children survive longer without their cancer coming back. Researchers want to see if this combination can also improve overall survival rates and how well the cancer responds to treatment at the end of the initial treatment phase. Additionally, they are examining whether this new approach causes different side effects compared to standard treatments and how factors like tumor characteristics and patient conditions affect outcomes. Participants in the study will undergo a series of treatments that include several cycles of chemotherapy drugs administered through an IV, and in some cases, orally. The study involves cycles of treatment, and based on how the tumor responds, patients may proceed to additional cycles or move on to a phase called Consolidation, which includes stem cell transplants. Throughout the study, tests such as scans and biopsies are conducted to evaluate the tumor's response to treatment. The study aims to measure results like event-free survival (how long patients live without the cancer coming back) and overall survival. Potential risks include common side effects of chemotherapy and immunotherapy, but the study also explores possible improvements in survival and quality of life for patients.

Official TitleA Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma
NCT06172296
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

478 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialGanglioneuroblastoma

Criteria

10 inclusion criteria required to participate
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

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

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)

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

Show More Criteria

8 exclusion criteria prevent from participating
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

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
See detailed description

Group II

Experimental
See detailed description

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 175 locations

Recruiting

Children's Hospital of Alabama

Birmingham, United StatesOpen Children's Hospital of Alabama in Google Maps
Recruiting

USA Health Strada Patient Care Center

Mobile, United States
Recruiting

Banner Children's at Desert

Mesa, United States
Recruiting

Phoenix Childrens Hospital

Phoenix, United States
Recruiting
175 Study Centers