N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
Recruiting now · Phase 2
Conditions studied: High-risk Neuroblastoma, Neuroblastoma, Childhood Neuroblastoma
In brief
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
Key facts
- Study ID
- NCT06528496
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 45
- Starts
- 2024-07-22
- Expected to finish
- 2029-07-22
- Last updated by the study team
- 2026-07-22
Who can join
Age: 2 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
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
- °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
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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