N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jul 25, 2024

Keywords

ClinConnect Summary

The N10 clinical trial is looking at a new way to treat children with high-risk neuroblastoma, a type of cancer that can be very challenging to manage. The study aims to see if a treatment called N10, which combines less chemotherapy with a special type of medicine known as a monoclonal antibody, is safe and works well for young patients. This trial is currently recruiting children and young adults up to 19 years old who have been diagnosed with neuroblastoma and have specific characteristics, such as certain genetic markers that indicate a higher risk.

Eligible participants must have either a confirmed diagnosis of neuroblastoma and meet certain medical criteria, or have received no more than one prior round of chemotherapy for this condition. If you or someone you know is considering joining this trial, it's important to be aware that participants will need to sign a consent form to show they understand the treatment is still being tested. Throughout the study, participants will be closely monitored to ensure their safety and the effectiveness of the treatment. This trial could be an important step in finding better options for children facing this serious illness.

Gender

ALL

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 \> grade 2
• • Inability to comply with protocol requirements
• • Pregnancy