Dinutuximab with Chemotherapy for High-Risk Neuroblastoma

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

Recruiting Phase 3 Interventional Study
Ganglioneuroblastoma, Nodular Neuroblastoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
Up to 30
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
478 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for children diagnosed with high-risk neuroblastoma. Those who join will receive treatment that includes chemotherapy and a drug called dinutuximab, which helps the immune system fight cancer cells.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 30 years old or younger at diagnosis.
  • I have been diagnosed with neuroblastoma or ganglioneuroblastoma.
  • I have a body surface area of at least 0.25 m².
  • I have consented to testing through a specific initiative before joining this trial.
  • I have high-risk neuroblastoma as defined in the trial criteria.
  • I am HIV positive but on effective anti-retroviral therapy with an undetectable viral load.
  • I meet the required serum creatinine levels based on my age and sex.
  • I am able to tolerate Peripheral Blood Stem Cell collection.

You may not be able to join if

  • I am between 365 and 546 days old with a specific type of neuroblastoma.
  • I am 547 days or older with low-risk neuroblastoma.
  • I have a known bone marrow failure syndrome.
  • I am on chronic immunosuppressive medication.
  • I have a primary immunodeficiency syndrome needing immune globulin therapy.
  • I am pregnant or plan to breastfeed my child.
  • I am sexually active and not using effective contraception.
  • I do not meet the informed consent and regulatory requirements.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 neur…
Trial Locations
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Eligibility Criteria
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) o…
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