Status:
RECRUITING
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
High-risk Neuroblastoma
Neuroblastoma
Eligibility:
All Genders
18-19 years
Phase:
PHASE2
Brief 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
- 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
- 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
Key Trial Info
Start Date :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 22 2029
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06528496
Start Date
July 22 2024
End Date
July 22 2029
Last Update
November 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065