Actively Recruiting
N10: Reduced Therapy for High-Risk Neuroblastoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-10
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a reduced chemotherapy and monoclonal antibody-based therapy regimen called N10 for children with high-risk neuroblastoma, a type of cancer affecting young patients. This Phase 2 study aims to find out if this approach is a safe and effective treatment option for children diagnosed with this condition. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on children aged 1.5 to under 19 years with specific high-risk neuroblastoma characteristics. Participants will receive four cycles of induction chemotherapy followed by a response-based intervention. The treatment involves a combination of drugs, including DANYELZA, a humanized monoclonal antibody, and several chemotherapy agents such as Cytoxan, Topotecan, Vincristine, Doxorubicin, Ifosfamide, Etoposide, Carboplatin, Irinotecan, and Temozolomide. The chemotherapy cycles are given over a 21-day period, and the participant's response is evaluated after two cycles of monoclonal antibody-based therapy. Throughout the study, participants will be closely monitored with assessments to evaluate their response to treatment after each therapy cycle. The main outcome measure is the participant's response after two cycles of monoclonal antibody therapy. The study includes ongoing safety monitoring and follow-up to track treatment effects. Participation spans from the start of treatment through response evaluation, with study procedures designed to support careful observation of each child's health and treatment progress.
CONDITIONS
Brief Title
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of neuroblastoma confirmed by histopathology, bone marrow metastases with high urine catecholamine levels, or positive MIBG scan
- High-risk neuroblastoma defined as MYCN-amplified stage L2/M/MS at any age, or stage M in patients older than 18 months
- No more than one prior cycle of high-risk neuroblastoma chemotherapy
- Age less than 19 years
- Signed informed consent acknowledging investigational treatment nature
You will not qualify if you...
- Severe dysfunction of major organs (renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal) at grade 3 or higher
- Inability to comply with study protocol requirements
- Pregnancy
- Organ dysfunction caused directly by tumor, metastases, or related paraneoplastic syndromes, or complications from treatments for these, are not exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple 21-day cycles until completion of 4 induction cycles and subsequent mAb therapy
Participants receive 4 cycles of induction chemotherapy followed by a response-based monoclonal antibody (mAb) therapy.
Visits every 21 days for each treatment cycle
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
B
Brian Kushner, MD
F
Fiorella Iglasias Cardenas, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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