N10: Reduced Therapy for High-Risk Neuroblastoma
Memorial Sloan Kettering Cancer Center
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
- Age range
- 1–19 years
- Sex
- All
- Healthy volunteers
- No
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 d…
Interventions
- BiologicalDANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
- BiologicalSargramostim
Yeast derived recombinant human Sargramostim (GM-CSF)
- DrugCytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard
- DrugTopotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
- DrugVincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
- DrugDoxorubicin
Doxorubicin is an anthracycline antibiotic
- DrugIfosfamide
Location
- Memorial Sloan Kettering Cancer CenterNew York, New York