NCT06528496 · Memorial Sloan Kettering Cancer Center
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
What this study is about
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
View original scientific description
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
Interventions
BIOLOGICAL
DANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
BIOLOGICAL
Sargramostim
Yeast derived recombinant human Sargramostim (GM-CSF)
DRUG
Cytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard
DRUG
Topotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
DRUG
Vincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
DRUG
Doxorubicin
Doxorubicin is an anthracycline antibiotic
DRUG
Ifosfamide
Ifosfamide is a structural analogue of cyclophosphamide
DRUG
Etoposide
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).
DRUG
Carboplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
DRUG
Irinotecan
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
DRUG
Temozolomide
Temozolomide is administered intravenously
RADIATION
Radiation Therapy
Between first and second cycle of antibody
Primary outcome measures
Evaluate participant response
Time frame: After 2 cycles of mAb-based therapy (each cycle is 21 days)
To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \>/= to grade 3 °Organ dysfunction due to direct effects of primary tumor or metastatic disease, or due to paraneoplastic syndromes associated with neuroblastoma, will not be considered in exclusion criteria. Similarly, complications of interventions to control above direct effects (e.g., steroid- induced hyperglycemia or hypertension) will also not be considered in exclusion criteria
- Inability to comply with protocol requirements
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2026 · Source of record for eligibility and locations