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Dinutuximab + Chemotherapy for High-Risk Neuroblastoma

Phase 3
Recruiting
Led By Sara M Federico
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
≤ 30 years at the time of initial diagnosis with high-risk disease
Must not have
Patients on chronic immunosuppressive medications for reasons other than specified
Patients with known bone marrow failure syndromes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if adding a monoclonal antibody called dinutuximab to standard treatments like chemotherapy and stem cell transplantation can help treat children with a type of cancer called high risk neuroblast

Who is the study for?
This trial is for children with high-risk neuroblastoma, a type of cancer. It's open to those under 30 at diagnosis and includes various stages of the disease if certain conditions are met, like specific genetic features or prior limited treatment. Participants need a minimum body surface area and must consent to molecular testing.
What is being tested?
The study tests dinutuximab added to induction chemotherapy, followed by surgery, radiation therapy, stem cell transplantation, and more chemo. Dinutuximab targets cancer cells for immune destruction; other drugs aim to stop cancer growth or spread.
What are the potential side effects?
Possible side effects include reactions from the monoclonal antibody dinutuximab, damage to organs from chemotherapy (like heart or bone marrow), increased risk of infections due to weakened immunity after stem cell transplant, and general side effects such as nausea and hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with a high-risk disease before turning 31.
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I haven't had cancer treatment except as allowed in the criteria.
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My neuroblastoma is high risk based on age, stage, and MYCN status.
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My body surface area is at least 0.25 square meters.
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I have been diagnosed with neuroblastoma or ganglioneuroblastoma.
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I received emergency radiation for critical or life-threatening cancer before or right after my diagnosis was confirmed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on long-term immunosuppressive medication for a condition not specified.
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I have a condition that affects my bone marrow's ability to produce blood cells.
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I am not pregnant, breastfeeding, and I use effective birth control.
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I have a primary immunodeficiency and need regular immune globulin therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event free survival (EFS)
Secondary study objectives
End of Induction (EOI) response rate
GD2 expression
Incidence of adverse events
+1 more
Other study objectives
Adequacy of diagnostic biopsy specimens
Association between tumor and host factors and outcomes
Associations between end of induction (EOI) response and individual response components
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (Dinutuximab in induction)Experimental Treatment25 Interventions
See detailed description
Group II: Arm A (SOC treatment)Active Control25 Interventions
See detailed description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
2017
Completed Phase 3
~2890
Temozolomide
2010
Completed Phase 3
~1880
Dinutuximab
2009
Completed Phase 3
~710
Radionuclide Imaging
2004
Completed Phase 2
~50
Irinotecan
2017
Completed Phase 3
~2590
Cisplatin
2013
Completed Phase 3
~3120
Cyclophosphamide
2010
Completed Phase 4
~2310
Melphalan
2008
Completed Phase 3
~1500
Radiation Therapy
2017
Completed Phase 3
~7250
Vincristine
2003
Completed Phase 4
~2970
Carboplatin
2014
Completed Phase 3
~6120
Doxorubicin
2012
Completed Phase 3
~8030
Leukapheresis
2016
Completed Phase 2
~710
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Computed Tomography
2017
Completed Phase 2
~2790
Isotretinoin
2019
Completed Phase 4
~3520
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Thiotepa
2008
Completed Phase 3
~2120
Biospecimen Collection
2004
Completed Phase 3
~2030
Etoposide
2010
Completed Phase 3
~2960

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,111,615 Total Patients Enrolled
206 Trials studying Neuroblastoma
53,089 Patients Enrolled for Neuroblastoma
Sara M FedericoPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Neuroblastoma
42 Patients Enrolled for Neuroblastoma
~319 spots leftby Dec 2029
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