N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
N10: Reduced Therapy for High-Risk Neuroblastoma
Memorial Sloan Kettering Cancer Center
45 participants
Jul 22, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria3
- Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \>/= to grade 3
- Inability to comply with protocol requirements
- Pregnancy
Interventions
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
Yeast derived recombinant human Sargramostim (GM-CSF)
Cyclophosphamide is an alkylating agent related to nitrogen mustard
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
Doxorubicin is an anthracycline antibiotic
Ifosfamide is a structural analogue of cyclophosphamide
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
Temozolomide is administered intravenously
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06528496