[{"id":"52425dc1-74c8-49b8-8efe-2388d72e2562","acronym":"","url":"https://clinicaltrials.gov/study/NCT06172296","created_at":"2023-12-15T20:18:48.678Z","updated_at":"2025-02-25T14:04:06.256Z","phase":"Phase 3","brief_title":"Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","source_id_and_acronym":"NCT06172296","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" ALK • TERT • MYCN","pipe":"","alterations":" ","tags":["ALK • TERT • MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • irinotecan • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • dexrazoxane"],"overall_status":"Recruiting","enrollment":" Enrollment 478","initiation":"Initiation: 04/19/2024","start_date":" 04/19/2024","primary_txt":" Primary completion: 12/31/2029","primary_completion_date":" 12/31/2029","study_txt":" Completion: 12/31/2029","study_completion_date":" 12/31/2029","last_update_posted":"2025-02-19"},{"id":"4b1b80e8-bcd8-4a78-8ae1-fe238c0362b8","acronym":"","url":"https://clinicaltrials.gov/study/NCT03126916","created_at":"2021-01-18T15:24:54.957Z","updated_at":"2025-02-25T15:10:35.328Z","phase":"Phase 3","brief_title":"Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)","source_id_and_acronym":"NCT03126916","lead_sponsor":"Children's Oncology Group","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • Xalkori (crizotinib) • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • cyclophosphamide intravenous • dexrazoxane"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 724","initiation":"Initiation: 05/14/2018","start_date":" 05/14/2018","primary_txt":" Primary completion: 09/30/2026","primary_completion_date":" 09/30/2026","study_txt":" Completion: 09/30/2026","study_completion_date":" 09/30/2026","last_update_posted":"2025-02-13"},{"id":"f48f1b5b-016c-486a-b2f8-c14558815182","acronym":"","url":"https://clinicaltrials.gov/study/NCT03794349","created_at":"2023-11-21T16:15:50.470Z","updated_at":"2025-02-25T15:11:00.647Z","phase":"Phase 2","brief_title":"Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma","source_id_and_acronym":"NCT03794349","lead_sponsor":"Children's Oncology Group","biomarkers":" IFNG • IL6 • CD276 • TNFA","pipe":"","alterations":" ","tags":["IFNG • IL6 • CD276 • TNFA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 95","initiation":"Initiation: 07/08/2019","start_date":" 07/08/2019","primary_txt":" Primary completion: 03/31/2025","primary_completion_date":" 03/31/2025","study_txt":" Completion: 03/31/2025","study_completion_date":" 03/31/2025","last_update_posted":"2025-02-13"},{"id":"71628f3d-27a7-487c-a8bd-86587a5fa22b","acronym":"","url":"https://clinicaltrials.gov/study/NCT00026312","created_at":"2023-11-21T19:15:23.482Z","updated_at":"2025-02-25T16:50:44.915Z","phase":"Phase 3","brief_title":"Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma","source_id_and_acronym":"NCT00026312","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" MYCN • NCR3LG1","pipe":"","alterations":" ","tags":["MYCN • NCR3LG1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 1449","initiation":"Initiation: 10/18/2001","start_date":" 10/18/2001","primary_txt":" Primary completion: 01/12/2012","primary_completion_date":" 01/12/2012","study_txt":" Completion: 03/07/2025","study_completion_date":" 03/07/2025","last_update_posted":"2025-02-04"},{"id":"1fd5f0e8-8e90-49e8-8707-ca043ad0939b","acronym":"","url":"https://clinicaltrials.gov/study/NCT02169609","created_at":"2021-01-18T10:06:37.044Z","updated_at":"2024-07-02T16:35:08.309Z","phase":"Phase 2","brief_title":"Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma","source_id_and_acronym":"NCT02169609","lead_sponsor":"Fundació Sant Joan de Déu","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Completed","enrollment":" Enrollment 24","initiation":"Initiation: 11/26/2014","start_date":" 11/26/2014","primary_txt":" Primary completion: 12/26/2016","primary_completion_date":" 12/26/2016","study_txt":" Completion: 12/31/2018","study_completion_date":" 12/31/2018","last_update_posted":"2024-04-22"},{"id":"0130cadc-804e-436f-a2b2-19a2f539a6a6","acronym":"NCI-2018-03732","url":"https://clinicaltrials.gov/study/NCT03786783","created_at":"2021-01-18T18:43:54.532Z","updated_at":"2024-07-02T16:35:09.101Z","phase":"Phase 2","brief_title":"Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma","source_id_and_acronym":"NCT03786783 - NCI-2018-03732","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" MYCN • IL6 • CXCL9","pipe":" | ","alterations":" MYCN amplification • IL6 expression","tags":["MYCN • IL6 • CXCL9"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification • IL6 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • cyclophosphamide intravenous • dexrazoxane"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 42","initiation":"Initiation: 03/04/2019","start_date":" 03/04/2019","primary_txt":" Primary completion: 12/31/2021","primary_completion_date":" 12/31/2021","study_txt":" Completion: 09/22/2024","study_completion_date":" 09/22/2024","last_update_posted":"2024-04-17"},{"id":"7442a163-6eec-47a9-bb41-9d083af1512d","acronym":"","url":"https://clinicaltrials.gov/study/NCT01857934","created_at":"2021-01-18T08:18:15.837Z","updated_at":"2024-07-02T16:35:23.492Z","phase":"Phase 2","brief_title":"Therapy for Children With Advanced Stage Neuroblastoma","source_id_and_acronym":"NCT01857934","lead_sponsor":"St. Jude Children's Research Hospital","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • cyclophosphamide intravenous • humanised dinutuximab (Hu14.18K322A)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 153","initiation":"Initiation: 07/05/2013","start_date":" 07/05/2013","primary_txt":" Primary completion: 10/21/2021","primary_completion_date":" 10/21/2021","study_txt":" Completion: 12/01/2024","study_completion_date":" 12/01/2024","last_update_posted":"2024-01-15"},{"id":"b416dd45-a8ba-466a-a54a-78992360eccd","acronym":"ANBL19P1","url":"https://clinicaltrials.gov/study/NCT04385277","created_at":"2021-01-18T21:10:20.111Z","updated_at":"2024-07-02T16:35:28.479Z","phase":"Phase 2","brief_title":"Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)","source_id_and_acronym":"NCT04385277 - ANBL19P1","lead_sponsor":"Children's Oncology Group","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 34","initiation":"Initiation: 12/31/2020","start_date":" 12/31/2020","primary_txt":" Primary completion: 06/30/2023","primary_completion_date":" 06/30/2023","study_txt":" Completion: 09/26/2024","study_completion_date":" 09/26/2024","last_update_posted":"2023-11-21"},{"id":"5b063683-e06b-4699-9a29-422d240e8a26","acronym":"","url":"https://clinicaltrials.gov/study/NCT03332667","created_at":"2021-07-05T17:09:29.759Z","updated_at":"2024-07-02T16:35:34.961Z","phase":"Phase 1","brief_title":"MIBG With Dinutuximab +/- Vorinostat","source_id_and_acronym":"NCT03332667","lead_sponsor":"New Approaches to Neuroblastoma Therapy Consortium","biomarkers":" CD34","pipe":"","alterations":" ","tags":["CD34"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 45","initiation":"Initiation: 09/12/2018","start_date":" 09/12/2018","primary_txt":" Primary completion: 06/15/2023","primary_completion_date":" 06/15/2023","study_txt":" Completion: 06/01/2024","study_completion_date":" 06/01/2024","last_update_posted":"2023-10-03"}]