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    BIOMARKER:

    MYCN amplification

    i
    Other names: MYCN, MYCN Proto-Oncogene BHLH Transcription Factor, V-Myc Avian Myelocytomatosis Viral Oncogene Neuroblastoma Derived Homolog, Class E Basic Helix-Loop-Helix Protein 37, N-Myc Proto-Oncogene Protein, BHLHe37, NMYC, Neuroblastoma-Derived V-Myc Avian Myelocytomatosis Viral Related Oncogene, Neuroblastoma MYC Oncogene, Oncogene NMYC, BHLHE37, MODED, N-Myc, ODED
    Entrez ID:
    4613
    Related biomarkers:
    Expression
    Others
    Apply
    A Study of N9 Chemotherapy in Children With Neuroblastoma (NCT04947501)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    06/11/2024
    Initiation :
    06/22/2021
    Primary completion :
    06/22/2025
    Completion :
    06/22/2025
    MYCN
    |
    MYCN amplification
    |
    carboplatin • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • vincristine • topotecan • mesna • cyclophosphamide intravenous
    Study of Oral MRT-2359 in Selected Cancer Patients (NCT05546268)
    Phase 1/2
    Monte Rosa Therapeutics, Inc
    Recruiting
    Last update posted :
    06/11/2024
    Initiation :
    10/12/2022
    Primary completion :
    05/01/2026
    Completion :
    11/01/2027
    MYC • MYCN
    |
    MYCN amplification • MYC expression
    |
    Xtandi (enzalutamide) • fulvestrant • MRT-2359
    A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma (NCT04936529)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    06/07/2024
    Initiation :
    08/02/2021
    Primary completion :
    06/15/2025
    Completion :
    06/15/2025
    MYC • MYCN • CSF2
    |
    MYCN amplification
    PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications (NCT06161519)
    Phase 1/2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    06/05/2024
    Initiation :
    01/31/2024
    Primary completion :
    11/14/2028
    Completion :
    11/14/2033
    MYCN
    |
    MYCN amplification
    |
    PLX038
    Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (NCT00911560)
    Phase 1/2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    06/05/2024
    Initiation :
    05/27/2009
    Primary completion :
    05/01/2025
    Completion :
    05/01/2025
    MYCN
    |
    MYCN amplification
    |
    GD2-GD3 Vaccine
    A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma (NCT06057948)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    05/24/2024
    Initiation :
    09/21/2023
    Primary completion :
    03/21/2026
    Completion :
    03/21/2026
    MYCN
    |
    MYCN amplification
    High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) (HR-NBL2) (NCT04221035)
    Phase 3
    Gustave Roussy, Cancer Campus, Grand Paris
    Recruiting
    Last update posted :
    05/15/2024
    Initiation :
    11/05/2019
    Primary completion :
    11/01/2026
    Completion :
    11/01/2032
    MYCN • MYCL
    |
    MYCN amplification • MYCL amplification
    |
    cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • irinotecan • vincristine • dacarbazine • melphalan • thiotepa • Qarziba (dinutuximab beta) • busulfan • cyclophosphamide intravenous • vindesine
    Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma (NCT02245997)
    Phase N/A
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    04/25/2024
    Initiation :
    09/01/2014
    Primary completion :
    09/01/2024
    Completion :
    09/01/2024
    MYCN
    |
    MYCN amplification
    Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma (NCT02169609)
    Phase 2
    Fundació Sant Joan de Déu
    Completed
    Last update posted :
    04/22/2024
    Initiation :
    11/26/2014
    Primary completion :
    12/26/2016
    Completion :
    12/31/2018
    MYCN
    |
    MYCN amplification
    |
    Unituxin (dinutuximab) • Leukine (sargramostim)
    Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (NCT03126916)
    Phase 3
    Children's Oncology Group
    Active, not recruiting
    Last update posted :
    04/22/2024
    Initiation :
    05/14/2018
    Primary completion :
    09/30/2026
    Completion :
    09/30/2026
    MYCN
    |
    MYCN amplification
    |
    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
    Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (NCI-2018-03732) (NCT03786783)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    04/17/2024
    Initiation :
    03/04/2019
    Primary completion :
    12/31/2021
    Completion :
    09/22/2024
    MYCN • IL6 • CXCL9
    |
    MYCN amplification • IL6 expression
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • cyclophosphamide intravenous • dexrazoxane
    Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma (NCT00904241)
    Phase N/A
    Children's Oncology Group
    Recruiting
    Last update posted :
    04/16/2024
    Initiation :
    11/06/2000
    Primary completion :
    01/01/2100
    MYCN
    |
    MYCN amplification
    Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PEDS-PLAN) (NCT02559778)
    Phase 2
    Giselle Sholler
    Recruiting
    Last update posted :
    04/08/2024
    Initiation :
    09/01/2015
    Primary completion :
    09/01/2030
    Completion :
    09/01/2035
    MYCN
    |
    MYCN amplification
    |
    dasatinib • sorafenib • Zykadia (ceritinib) • Zolinza (vorinostat)
    Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (NCT05489887)
    Phase 2
    Giselle Sholler
    Recruiting
    Last update posted :
    04/08/2024
    Initiation :
    09/14/2022
    Primary completion :
    09/01/2026
    Completion :
    09/01/2033
    MYCN
    |
    MYCN amplification
    |
    Zykadia (ceritinib) • Danyelza (naxitamab-gqgk)
    DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma (NCT04696029)
    Phase 2
    Giselle Sholler
    Recruiting
    Last update posted :
    04/08/2024
    Initiation :
    03/29/2021
    Primary completion :
    03/01/2028
    Completion :
    03/01/2029
    TP53 • MYC • MYCN
    |
    TP53 mutation • MYCN amplification • TP53 amplification
    Molecular-Guided Therapy for Childhood Cancer (NCT02162732)
    Phase N/A
    Giselle Sholler
    Completed
    Last update posted :
    04/05/2024
    Initiation :
    07/08/2014
    Primary completion :
    01/18/2024
    Completion :
    01/18/2024
    MYCN
    |
    MYCN amplification
    Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer (NCT03936465)
    Phase 1
    Dana-Farber Cancer Institute
    Active, not recruiting
    Last update posted :
    03/21/2024
    Initiation :
    09/27/2019
    Primary completion :
    07/16/2024
    Completion :
    07/16/2024
    MYC • MYCN • BRD4 • BRD3
    |
    MYCN amplification
    |
    ezobresib (BMS-986158) • trotabresib (BMS-986378)
    Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (NCT01798004)
    Phase 1
    Children's Oncology Group
    Active, not recruiting
    Last update posted :
    03/13/2024
    Initiation :
    04/08/2013
    Primary completion :
    07/28/2015
    MYCN
    |
    MYCN amplification • MYCN expression
    |
    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • busulfan • Neupogen (filgrastim) • cyclophosphamide intravenous
    Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma (NCT02909777)
    Phase 1
    Dana-Farber Cancer Institute
    Active, not recruiting
    Last update posted :
    03/11/2024
    Initiation :
    10/01/2016
    Primary completion :
    07/01/2024
    Completion :
    07/01/2024
    MYC • MYCN
    |
    MYCN amplification • MYC expression • MYCN expression
    |
    fimepinostat (CUDC-907)
    Auto Transplant for High Risk or Relapsed Solid or CNS Tumors (NCT01505569)
    Phase N/A
    Masonic Cancer Center, University of Minnesota
    Completed
    Last update posted :
    02/26/2024
    Initiation :
    10/20/2011
    Primary completion :
    02/01/2024
    Completion :
    02/01/2024
    MYCN • CD34
    |
    LDH elevation • MYCN amplification • MYCN expression
    |
    cisplatin • carboplatin • paclitaxel • ifosfamide • etoposide IV • melphalan • mesna • thiotepa • busulfan
    Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO) (NCT03496402)
    Phase N/A
    Institut Curie
    Recruiting
    Last update posted :
    02/05/2024
    Initiation :
    04/20/2018
    Primary completion :
    04/19/2027
    Completion :
    08/19/2027
    MYCN
    |
    MYCN amplification
    Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma (NCT02650648)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    02/02/2024
    Initiation :
    01/01/2016
    Primary completion :
    01/01/2025
    Completion :
    01/01/2025
    MYCN
    |
    MYCN amplification
    |
    cyclophosphamide • Danyelza (naxitamab-gqgk) • cyclophosphamide intravenous
    Therapy for Children With Advanced Stage Neuroblastoma (NCT01857934)
    Phase 2
    St. Jude Children's Research Hospital
    Active, not recruiting
    Last update posted :
    01/15/2024
    Initiation :
    07/05/2013
    Primary completion :
    10/21/2021
    Completion :
    12/01/2024
    MYCN
    |
    MYCN amplification
    |
    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)
    Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma (NCT01757626)
    Phase 1/2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    01/05/2024
    Initiation :
    12/01/2012
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    MYC • MYCN
    |
    MYCN amplification
    |
    cyclophosphamide • irinotecan • Danyelza (naxitamab-gqgk)
    Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin (NCT01175356)
    Phase 1
    Children's Oncology Group
    Active, not recruiting
    Last update posted :
    01/04/2024
    Initiation :
    10/04/2010
    Primary completion :
    09/28/2016
    Completion :
    09/28/2024
    MYCN
    |
    MYCN amplification
    |
    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • busulfan • Azedra (iobenguane I 131) • cyclophosphamide intravenous
    MCT for the Harvard/UCSF ROBIN Center (NCT06000787)
    Phase N/A
    Brigham and Women's Hospital
    Recruiting
    Last update posted :
    12/12/2023
    Initiation :
    09/19/2023
    Primary completion :
    08/31/2028
    Completion :
    08/31/2028
    MYCN
    |
    MYCN amplification
    |
    Azedra (iobenguane I 131)
    Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PersoMed-I) (NCT04402073)
    Phase 2
    European Organisation for Research and Treatmen...
    Recruiting
    Last update posted :
    12/11/2023
    Initiation :
    11/11/2022
    Primary completion :
    03/01/2030
    Completion :
    03/01/2030
    TP53 • BRCA2 • MYCN
    |
    TP53 wild-type • MYCN amplification
    |
    cisplatin • vincristine • lomustine • Odomzo (sonidegib)
    PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study (NCT02307630)
    Phase N/A
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    12/04/2023
    Initiation :
    11/01/2014
    Primary completion :
    11/01/2024
    Completion :
    11/01/2024
    MYCN
    |
    MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (ANBL19P1) (NCT04385277)
    Phase 2
    Children's Oncology Group
    Active, not recruiting
    Last update posted :
    11/21/2023
    Initiation :
    12/31/2020
    Primary completion :
    06/30/2023
    Completion :
    09/26/2024
    MYCN
    |
    MYCN amplification
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    An Intermediate Expanded Use Trial of DFMO (NCT03581240)
    Phase N/A
    Giselle Sholler
    Available
    Last update posted :
    09/28/2023
    MYCN
    |
    MYCN amplification • MYCN expression
    Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors (NCT02095132)
    Phase 1/2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    09/26/2023
    Initiation :
    03/28/2014
    Primary completion :
    12/31/2020
    Completion :
    06/30/2023
    MYCN • AFP
    |
    MYCN amplification
    |
    adavosertib (AZD1775) • irinotecan
    Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response. (NCT06047535)
    Phase 4
    SciClone Pharmaceuticals
    Not yet recruiting
    Last update posted :
    09/21/2023
    Initiation :
    10/31/2023
    Primary completion :
    06/15/2027
    Completion :
    08/15/2027
    MYCN
    |
    MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    Study of Chemoimmunotherapy for High-Risk Neuroblastoma (NCT03189706)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    09/12/2023
    Initiation :
    06/12/2017
    Primary completion :
    06/01/2024
    Completion :
    06/01/2024
    MYCN
    |
    MYCN amplification
    |
    temozolomide • irinotecan • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)
    European Low and Intermediate Risk Neuroblastoma Protocol (NCT01728155)
    Phase 3
    Instituto de Investigacion Sanitaria La Fe
    Completed
    Last update posted :
    09/08/2023
    Initiation :
    01/01/2011
    Primary completion :
    12/31/2022
    MYCN
    |
    MYCN amplification
    Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors (NCT01419834)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Completed
    Last update posted :
    08/04/2023
    Initiation :
    08/15/2011
    Primary completion :
    08/02/2023
    Completion :
    08/02/2023
    MYCN
    |
    MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma (NCT03033303)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    07/04/2023
    Initiation :
    01/23/2017
    Primary completion :
    06/01/2024
    Completion :
    06/01/2024
    MYCN
    |
    MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    Naxitamab and GM-CSF in People With Neuroblastoma (NCT04501757)
    Phase N/A
    Memorial Sloan Kettering Cancer Center
    No Longer Available
    Last update posted :
    12/08/2022
    MYCN
    |
    MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma (NCT00072358)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Completed
    Last update posted :
    05/16/2022
    Initiation :
    07/01/2003
    Primary completion :
    01/15/2021
    Completion :
    01/15/2021
    MYCN • CSF2
    |
    MYCN amplification
    |
    temozolomide • irinotecan • Leukine (sargramostim)
    Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma (NCT00567567)
    Phase 3
    Children's Oncology Group
    Completed
    Last update posted :
    04/28/2022
    Initiation :
    11/05/2007
    Primary completion :
    02/27/2015
    Completion :
    03/31/2022
    CD8 • MYCN • UGT1A1 • CD4
    |
    MYCN amplification • UGT1A1*1*1
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • topotecan • melphalan • Marqibo (vincristine liposomal) • thiotepa • Neupogen (filgrastim) • cyclophosphamide intravenous
    Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma (NCT00492167)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Completed
    Last update posted :
    03/07/2022
    Initiation :
    09/09/2005
    Primary completion :
    03/04/2022
    Completion :
    03/04/2022
    MYCN
    |
    MYCN amplification