NCT06528496 N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
| NCT ID | NCT06528496 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | High-risk Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-07-22 |
| Primary Completion | 2029-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2024-07-22 with a primary completion date of 2029-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Brian Kushner, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06528496 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 19 Years, studying High-risk Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06528496 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06528496 currently recruiting?
Yes, NCT06528496 is actively recruiting participants. Contact the research team at kushnerb@MSKCC.ORG for enrollment information.
Where is the NCT06528496 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06528496 clinical trial?
NCT06528496 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Brian Kushner, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 45 participants.