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N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
RecruitingPhase 2
N10: Reduced Therapy for High-Risk Neuroblastoma
Who can join
18 Months – 19 Years · All sexes
Full eligibility criteria
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 * Pregnancy
About the study
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
What is being tested
- DANYELZA (biological)
- Sargramostim (biological)
- Cytoxan (drug)
- Topotecan (drug)
- Vincristine (drug)
- Doxorubicin (drug)
Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 45 · Started: Jul 22, 2024
Contact the study team
- Brian Kushner, MD · Phone: 8336755491
Official record on ClinicalTrials.gov — NCT06528496
Locations in the U.S.
| New York | Memorial Sloan Kettering Cancer Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.