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Recruiting
NCT06528496
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
Conditions: High-risk Neuroblastoma, Neuroblastoma, Childhood Neuroblastoma
Sex: All
Ages: 18 Months – 19 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 45
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Cancer Center New York New York
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.
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 \/= 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
Source: ClinicalTrials.gov (NCT06528496). StuddyBuddy aggregates publicly available trial information.
