N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
N10: Reduced Therapy for High-Risk Neuroblastoma
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2024
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2024
CompletedStudy Start
First participant enrolled
July 22, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 22, 2029
February 10, 2026
February 1, 2026
5 years
July 22, 2024
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate participant response
To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients.
After 2 cycles of mAb-based therapy (each cycle is 21 days)
Study Arms (1)
Participants with Neuroblastoma
EXPERIMENTALParticipants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Interventions
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
Doxorubicin is an anthracycline antibiotic
Ifosfamide is a structural analogue of cyclophosphamide
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
Temozolomide is administered intravenously
Cyclophosphamide is an alkylating agent related to nitrogen mustard
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
Yeast derived recombinant human Sargramostim (GM-CSF)
Eligibility Criteria
You may qualify if:
- Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
- HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients \>18 months old.
- No more than one prior cycle of HR-NB chemotherapy
- Age \<19 years.
- Signed informed consent indicating awareness of the investigational nature of this treatment.
You may not qualify if:
- Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \>/= to grade 3
- Inability to comply with protocol requirements
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Kushner, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2024
First Posted
July 30, 2024
Study Start
July 22, 2024
Primary Completion (Estimated)
July 22, 2029
Study Completion (Estimated)
July 22, 2029
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.