[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556699":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":95,"centralContacts":99,"locations":107,"responsibleParty":123,"collaborators":50,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":50,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":50,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":109,"whyStopped":50,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with Neuroblastoma","EXPERIMENTAL","Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.",[13,14,15,16,17,18,19,20,21,22,23],"Biological: DANYELZA","Biological: Sargramostim","Drug: Cytoxan","Drug: Topotecan","Drug: Vincristine","Drug: Doxorubicin","Drug: Ifosfamide","Drug: Etoposide","Drug: Carboplatin","Drug: Irinotecan","Drug: Temozolomide",[25,32,39,46,51,57,63,69,77,83,89],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","DANYELZA","DANYELZA is a humanized monoclonal antibody of the IgG1 subclass",[9],[31],"Naxitamab",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Sargramostim","Yeast derived recombinant human Sargramostim (GM-CSF)",[9],[37,38],"granulocyte-macrophage colony-stimulating factor","GM-CSF",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Cytoxan","Cyclophosphamide is an alkylating agent related to nitrogen mustard",[9],[45],"Cyclophosphamide",{"type":40,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Topotecan","Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.",[9],null,{"type":40,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Vincristine","Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).",[9],[56],"Oncovin",{"type":40,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Doxorubicin","Doxorubicin is an anthracycline antibiotic",[9],[62],"Adriamycin",{"type":40,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Ifosfamide","Ifosfamide is a structural analogue of cyclophosphamide",[9],[68],"Isophosphamide",{"type":40,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Etoposide","Etoposide for Injection is available as a 20 mg\u002FmL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).",[9],[74,75,76],"VePesid","Etopophos","VP-16",{"type":40,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Carboplatin","Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.",[9],[82],"Paraplatin",{"type":40,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Irinotecan","Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor",[9],[88],"Camptosar",{"type":40,"name":90,"description":91,"armGroupLabels":92,"otherNames":93},"Temozolomide","Temozolomide is administered intravenously",[9],[94],"Temodar",[96],{"name":97,"affiliation":5,"role":98},"Brian Kushner, MD","PRINCIPAL_INVESTIGATOR",[100,104],{"name":97,"role":101,"phone":102,"phoneExt":50,"email":103},"CONTACT","8336755491","kushnerb@MSKCC.ORG",{"name":105,"role":101,"phone":50,"phoneExt":50,"email":106},"Fiorella Iglasias Cardenas, MD, MS","iglesiaf@mskcc.org",[108],{"facility":5,"status":109,"city":110,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"RECRUITING","New York","10065","United States","US",{"type":115,"coordinates":116},"Point",[117,118],-74.00597,40.71427,{"lat":118,"lon":117},[121],{"name":97,"role":101,"phone":122,"phoneExt":50,"email":50},"212-639-6793",{"type":124,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100556699","phase-2-n10-a-study-of-reduced-chemotherapy-and-monoclonal-antibody-mab-based-therapy-in-children-with-neuroblastoma-100556699",false,"NCT06528496","N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma","N10: Reduced Therapy for High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.\n* HR-NB, defined as MYCN-amplified stage L2\u002FM\u002FMS at any age and stage M in patients \\>18 months old.\n* No more than one prior cycle of HR-NB chemotherapy\n* Age \\\u003C19 years.\n* Signed informed consent indicating awareness of the investigational nature of this treatment.\n\nExclusion Criteria:\n\n* Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \\>\u002F= to grade 3\n\n  °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\n* Inability to comply with protocol requirements\n* Pregnancy","ALL","18 Months","19 Years",{"count":136,"type":137},45,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.",[143,144,145],"High-risk Neuroblastoma","Neuroblastoma","Childhood Neuroblastoma",[147,148,149,150,5,151],"High-risk neuroblastoma","neuroblastoma","childhood neuroblastoma","N10","24-144","2026-02-09",{"date":154,"type":155},"2026-02-10","ACTUAL",{"date":157,"type":155},"2024-07-22",{"date":159,"type":137},"2029-07-22",{"name":5,"class":6},1]