[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529324":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":84,"studyPopulation":80,"armGroups":85,"interventions":122,"overallOfficials":548,"centralContacts":80,"locations":553,"responsibleParty":3108,"collaborators":80,"id":3110,"slug":3111,"hasResults":3112,"nctId":3113,"briefTitle":3114,"officialTitle":3115,"acronym":80,"eligibilityCriteria":3116,"healthyVolunteers":3112,"sex":3117,"minAge":80,"maxAge":3118,"enrollmentInfo":3119,"targetDuration":80,"studyType":3122,"phases":3123,"briefSummary":3125,"conditions":3126,"keywords":80,"overallStatus":556,"whyStopped":80,"lastUpdateSubmitDate":3129,"lastUpdatePostDateStruct":3130,"startDateStruct":3133,"completionDateStruct":3135,"leadSponsor":3137,"locationsCount":3138},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Event free survival (EFS)","EFS time is calculated from time of randomization to Arms A or B to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.","Up to 3 years",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"End of Induction (EOI) response rate","The response rate will be calculated among all evaluable patients at end of Induction. Responders are defined as patients who achieve a \\>= partial response per the revised 2017 International Neuroblastoma Response Criteria (INRC)","From randomization to end of extended Induction, up to 12 months",{"measure":19,"description":20,"timeFrame":12},"Overall survival (OS)","OS time is calculated from time of randomization to Arms A or B until death, or until last contact if patient is alive.",{"measure":22,"description":23,"timeFrame":24},"Incidence of adverse events","The proportion of patients with at least one grade 3 or higher non-hematologic toxicity or grade 4 or higher hematologic toxicity during protocol therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, will be reported.","Up to 2 years",{"measure":26,"description":27,"timeFrame":28},"GD2 expression","Dinutuximab binding to pre-therapy patient tumor samples will be measured and categorized as high or low.","Up to 12 months",[30,34,37,40,43,47,51,54,58,61,64,67,71,74],{"measure":31,"description":32,"timeFrame":33},"Association between tumor and host factors and outcomes","A series of univariate and multivariate Cox proportional hazards (for EFS and OS) and logistic regression (for responders vs. non-responders) models will be fit for patients in Arms A and B to evaluate the relationship between tumor and host factors (including tumor ALK and other somatic mutations, copy-number aberrations, gene fusions, gene expression, and pathogenic germline variants) and chemo-immunotherapy during Induction with outcome.","Up to 10 years",{"measure":35,"description":36,"timeFrame":33},"Circulating biomarkers and markers of minimal residual disease","Will be assessed by comparing the proportion of patients with detectable vs. non-detectable tumor markers (including circulating tumor deoxyribonucleic acid, circulating free DNA, circulating tumor cells, and immune function profiling) between Arms A and B during and after induction and post-consolidation therapy using chi-squared tests at each individual time point, and Cochran's Q across time points to determine if there is a consistent difference in proportions between arms across time. In addition, the tumor markers will be analyzed as continuous variables using longitudinal data analysis methodology such as mixed effects models or generalized estimating equations as appropriate.",{"measure":38,"description":39,"timeFrame":33},"Patterns of failure","The impact of early or late chemoimmunotherapy during Induction on the probability of the involvement of a specific disease site at first relapse will be evaluated using Fisher's exact test.",{"measure":41,"description":42,"timeFrame":33},"Effect of telomere maintenance mechanisms","A series of univariate and multivariate Cox proportional hazards (for EFS and OS) and logistic regression (for responders vs. non-responders) models will be fit for patients in arms A and B to evaluate the relationship between telomere maintenance mechanism and chemoimmunotherapy during Induction with outcome. Patients will be classified into 3 groups by telomere maintenance mechanism (TMM) based on messenger ribonucleic acid expression of TERT and analysis of telomeric DNA C-circles: telomerase (TERT) positive, alternative of lengthening of telomeres (ALT) positive, or no identified TMM.",{"measure":44,"description":45,"timeFrame":46},"Functional and quality of life outcomes","Will descriptively summarize and compare the total Memorial Symptom Assessment Scale scores, total sub-domain scores, and individual symptom scores between patients randomized to receive dinutuximab during Induction (Arm B) to those of patients randomized to standard Induction (Arm A).","At serial time points during Induction, Extended Induction, Post-Consolidation, and at the end of therapy",{"measure":48,"description":49,"timeFrame":50},"Adequacy of diagnostic biopsy specimens","Will be evaluated by descriptively comparing the successful delineation of histologic classification, MYCN amplification status, and ALK status via the traditional method of obtaining tissue for diagnosis, open surgical biopsy, versus the less invasive percutaneous core needle biopsy.","At time of tissue collection",{"measure":52,"description":53,"timeFrame":33},"Associations between family-reported adverse social determinants of health and both clinical outcomes and biology","Kaplan-Meier curves of EFS and OS will be generated and used to calculate 3-year EFS and OS estimates. Associations between social determinants of health (SDOH) and survival outcomes and time to receipt of dinutuximab will be evaluated with univariate and multivariate Cox proportional hazard models. Log-binomial regression will be used to estimate risk ratios and 95% CI for the occurrence of dinutuximab consent to randomization and therapy receipt by SDOH exposure. Effect modification of outcomes as a function of poverty, stratified by race\u002Fethnicity, will be explored.",{"measure":55,"description":56,"timeFrame":57},"Develop and validate deep learning predictors of Induction response (imaging objective)","Scans will be given as input to a convolutional neural network trained to predict EOI response.","At diagnosis, EOI, during Extended Induction, and end of Extended Induction",{"measure":59,"description":60,"timeFrame":33},"Compare institutional versus central determination of overall response, individual response components, and PEIR and GEIR determination (imaging objective)","Will be assessed by calculating the percentage of patients receiving the same EOI institutional and centrally reviewed determination of overall response, individual response components (primary tumor, soft tissue and bone metastatic disease, and bone marrow metastatic disease), and PEIR and GEIR. In addition, Cohen's kappa will be calculated to evaluate the concordance in each of these response measures.",{"measure":62,"description":63,"timeFrame":33},"Incidence of late toxicities","Will be addressed by calculating the proportion of treated patients with each late effect, including but not limited to impaired organ function, neuropsychiatric toxicity, and secondary malignancy. A 95% confidence interval will be placed on each proportion.",{"measure":65,"description":66,"timeFrame":33},"Reduced dose radiotherapy to the primary site clinical target volume (CTV) in patients with complete response of the primary site at EOI results in comparable local control relative to historical cohorts","The cumulative incidence of local progression (CILP) in patients with complete response of the primary site at EOI and GEIR on this study will be compared to the CILP rate of 11.2±1.8% observed on ANBL0532 using Gray's test.",{"measure":68,"description":69,"timeFrame":70},"Post-transplant complications","Will be evaluated by calculating the incidence of endothelial injury complications and non-relapse mortality within 100 days of transplant, transplant-associated thrombotic microangiopathy (TA-TMA), severe TA-TMA, and sinusoidal obstruction syndrome (SOS) on Arms A and B and comparing between arms with a chi-squared test. The impact of TA-TMA occurrence on the timing or exclusion of subsequent therapy and interventions utilized to treat the TA-TMA, and associations with outcomes (EFS and OS) will be assessed.","Up to 100 days post-transplant",{"measure":72,"description":73,"timeFrame":33},"Associations between end of induction (EOI) response and individual response components","Log-rank tests will be used to explore the association between EOI response (using both the revised INRC and GEIR\u002FPEIR classification) and individual response components (primary tumor, soft tissue and bone metastatic disease, and bone marrow metastatic disease) with outcome (EFS and OS).",{"measure":75,"description":76,"timeFrame":33},"Changes in image-defined risk factors (IDRF)","The proportion of patients in the analytic cohort for whom each particular IDRF and also the presence of any IDRF is absent prior to surgical resection will be computed. McNemar's test for paired observations will be applied to determine whether there is a difference in the proportion of each IDRF and any IDRF present before and after initial therapy, and conditional logistic regression will be used to compare between treatment arms A and B. The IDRF status after initial therapy and whether there has been a change from diagnosis will be associated with surgical outcome (complete vs. incomplete resection, presence or absence of surgical complications) using chi-squared tests, and compared between treatment arms A and B with the Cochran-Mantel-Haenszel test. The association of IDRF status with presence or absence of local failure after primary tumor resection will also be evaluated using a chi-squared test, and compared between treatment arms A and B with the Cochran-Mantel-Haenszel.",{"allocation":78,"interventionModel":79,"interventionModelDescription":80,"primaryPurpose":81,"observationalModel":80,"timePerspective":80,"maskingInfo":82},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":83,"maskingDescription":80,"whoMasked":80},"NONE","PRIMARY OBJECTIVE:\n\nI. To determine if the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma assigned to early chemoimmunotherapy during Induction differs from that of patients who are not assigned to treatment that includes early chemoimmunotherapy.\n\nSECONDARY OBJECTIVES:\n\nI. To determine if early chemoimmunotherapy during Induction therapy improves end of Induction (EOI) response rates and overall survival (OS) for patients with newly diagnosed high-risk neuroblastoma.\n\nII. To determine response rates, EFS, and OS following an Extended Induction regimen with chemoimmunotherapy in patients with progressive disease or a poor response to Induction therapy.\n\nIII. To compare the toxicities experienced by patients treated with chemoimmunotherapy during Induction versus those experienced by patients treated with standard Induction and to describe toxicities experienced during Extended Induction.\n\nIV. To determine GD2 expression on tumor tissue and tumor cells in bone marrow and assess for associations with response and outcome.\n\nEXPLORATORY OBJECTIVES:\n\nI. To describe the association between tumor and host factors and outcomes in patients receiving protocol therapy.\n\nII. To evaluate circulating biomarkers and markers of minimal residual disease at baseline and during therapy, and assess for associations with response and outcome.\n\nIII. To compare patterns of failure between patients treated with and without dinutuximab during induction.\n\nIV. To determine the effect of telomere maintenance mechanisms on end of Induction response rates, EFS, and OS.\n\nV. To explore the impact of high-risk neuroblastoma (HRNBL) and its therapy, including the addition of dinutuximab to Induction chemotherapy, on functional and quality of life outcomes in patients with HRNBL, as measured by caregiver (parent\u002Flegal guardian) and patient questionnaires.\n\nVI. To describe the adequacy of diagnostic biopsy specimens, including those obtained by percutaneous core needle biopsy.\n\nVII. To explore the associations between family-reported adverse social determinants of health and both clinical outcomes and biology.\n\nVIII. To develop and validate deep learning predictors of Induction response based on diagnostic MIBG scans. (Imaging Objective) IX. To compare institutional versus central determination of overall response, individual response components (primary tumor, soft tissue and bone metastatic disease, and bone marrow metastatic disease), and poor end of induction response (PEIR) and good end of induction response (GEIR) determination. (Imaging Objective) X. To describe late toxicities (including impaired organ function, neuropsychiatric toxicity, and incidence of secondary malignancy) in patients treated with dinutuximab during Induction or Extended Induction to late toxicities in patients who have not received dinutuximab during these phases of therapy.\n\nXI. To evaluate whether reduced dose radiotherapy to the primary site clinical target volume (CTV) in patients with complete response of the primary site at EOI results in comparable local control relative to historical cohorts.\n\nXII. To compare post-transplant complications between treatment arms, and assess for associations with outcome.\n\nXIII. To assess for associations between EOI response (including good end of Induction response \\[GEIR\\] and poor end of Induction response \\[PEIR\\]) and individual response components (primary tumor, soft tissue and bone metastatic disease, and bone marrow metastatic disease) with outcome (EFS and OS).\n\nXIV. To describe and compare the changes in image-defined risk factors (IDRFs) between patients treated with and without dinutuximab during Induction and associate with surgical outcomes and local failure rates following primary tumor resection.\n\nXV. To bank serial samples of blood, bone marrow, and tumor tissue for future research.\n\nOUTLINE: Patients receive Induction cycle 1 and are then randomized to 1 of 2 treatment arms.\n\nINDUCTION CYCLE 1: Patients receive cyclophosphamide intravenously (IV) over 30 minutes and topotecan IV over 30 minutes on days 1-5 in the absence of unacceptable toxicity.\n\nARM A:\n\nINDUCTION CYCLES 2-5: Patients receive cyclophosphamide IV over 30 minutes and topotecan IV over 30 minutes on days 1-5 of cycle 2 in the absence of unacceptable toxicity. Patients then undergo stem cell harvest via apheresis. Patients then receive cisplatin IV over 4 hours and etoposide IV over 2 hours on days 1-3 of cycles 3 and 5, and vincristine IV on day 1, doxorubicin IV over 15 minutes, and cyclophosphamide IV over 1 hour on days 1-2 of cycle 4 in the absence of unacceptable toxicity. Patients undergo primary tumor resection after Induction cycle 4 or 5. Following Induction cycle 5, patients undergo testing to determine response to Induction therapy. Patients with a good tumor response proceed to Consolidation, while patients with a poor tumor response proceed to Extended Induction.\n\nEXTENDED INDUCTION: Patients with a poor tumor response or progression during Induction receive temozolomide orally (PO), via nasogastric tube (NG), or via gastric tube (G-tube) on days 1-5, irinotecan IV over 90 minutes on days 1-5, and dinutuximab IV over 10 hours. Treatment repeats every 21 days for up to a maximum of 6 cycles in the absence of disease progression or unacceptable toxicity. If at any time during Extended Induction testing shows a good tumor response, patients proceed to Consolidation. If after 6 cycles of Extended Induction or if at any time progression is noted, patients are removed from the study.\n\nCONSOLIDATION: Patients undergo two autologous hematopoietic stem cell transplantations (HSCTs) during Consolidation. Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2 during HSCT 1. Patients then receive stem cell infusion IV on day 0. Between 6 and 10 weeks after stem cell infusion, patients receive melphalan IV over 30 minutes on days -7 to -5, etoposide IV over 24 hours on days -7 to -4, and carboplatin over 24 hours on days -7 to -4 during HSCT 2. Patients receive stem cell infusion IV on day 0. Between day +42 and day +80 after HSCT 2. Patients receive radiation daily for 12 treatments in the absence of disease progression or unacceptable toxicity.\n\nPOST CONSOLIDATION: Patients receive dinutuximab IV over 10 hours on days 4-7 and isotretinoin PO twice daily (BID) on days 11-24 of cycles 1-5. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive isotretinoin PO BID on days 15-28 for 1 additional cycle, cycle 6.\n\nPatients undergo blood and urine sample collection, echocardiogram (ECHO) or multigated acquisition scan (MUGA), bone marrow aspiration and\u002For biopsy, computed tomography (CT) scan, magnetic resonance imaging (MRI), iodine-123 meta-iodobenzylguanidine (I-MIBG) scan and possible fluorodeoxyglucose position emission tomography (FDG-PET) scan throughout the study.\n\nARM B:\n\nINDUCTION CYCLES 2-5: Patients receive cyclophosphamide IV over 30 minutes, topotecan IV over 30 minutes on days 1-5, and dinutuximab IV over 10 hours on days 2-5 of cycle 2 in the absence of unacceptable toxicity. Patients then undergo stem cell harvest via apheresis. Patients receive cisplatin IV over 4 hours and etoposide IV over 2 hours on days 1-3 and dinutuximab IV over 10 hours on days 2-5 of cycles 3 and 5, and vincristine IV on day 1, doxorubicin IV over 15 minutes, and cyclophosphamide IV over 1 hour on days 1-2, and dinutuximab IV over 10 hours on days 2-5 of cycle 4 in the absence of unacceptable toxicity. Patients undergo primary tumor resection after Induction cycle 4 or 5. Following Induction cycle 5, patients undergo testing to determine response to Induction therapy. Patients with a good tumor response proceed to Consolidation, while patients with a poor tumor response proceed to Extended Induction.\n\nEXTENDED INDUCTION: Patients with a poor tumor response or progression during Induction receive temozolomide PO, via NG tube, or via G-tube on days 1-5, irinotecan IV over 90 minutes on days 1-5, and dinutuximab IV over 10 hours. Treatment repeats every 21 days for up to a maximum of 6 cycles in the absence of disease progression or unacceptable toxicity. If at any time during Extended Induction testing shows a good tumor response, patients proceed to Consolidation. If after 6 cycles of Extended Induction or if at any time progression is noted, patients are removed from the study.\n\nCONSOLIDATION: Patients undergo two autologous HSCTs during Consolidation. Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2 during HSCT 1. Patients then receive stem cell infusion IV on day 0. Between 6 and 10 weeks after stem cell infusion patients receive melphalan IV over 30 minutes on days -7 to -5, etoposide IV over 24 hours on days -7 to -4, and carboplatin over 24 hours on days -7 to -4 during HSCT 2. Patients receive stem cell infusion IV on day 0. Between day +42 and day +80 after HSCT 2, patients receive radiation daily for 12 treatments in the absence of disease progression or unacceptable toxicity.\n\nPOST CONSOLIDATION: Patients receive dinutuximab IV over 10 hours on days 4-7 and isotretinoin PO BID on days 11-24 of cycles 1-5. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive isotretinoin PO BID on days 15-28 for 1 additional cycle, cycle 6.\n\nPatients undergo blood and urine sample collection, ECHO or MUGA, bone marrow aspiration and\u002For biopsy, CT scan, MRI, I-MIBG scan and possible FDG-PET scan throughout the study.\n\nAfter completion of study treatment, patients are followed up at 3, 6, 9,12, 15, 18, 24, 30, 36, 42, 48, 54, and 60 months and then periodically for up to 10 years from enrollment.",[86,118],{"label":87,"type":88,"description":89,"interventionNames":90},"Arm A (SOC treatment)","ACTIVE_COMPARATOR","See detailed description",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117],"Procedure: Biospecimen Collection","Procedure: Bone Marrow Aspiration","Procedure: Bone Marrow Biopsy","Drug: Carboplatin","Drug: Cisplatin","Procedure: Computed Tomography","Drug: Cyclophosphamide","Biological: Dinutuximab","Drug: Doxorubicin","Procedure: Echocardiography Test","Drug: Etoposide","Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan","Procedure: Hematopoietic Cell Transplantation","Drug: Irinotecan","Drug: Isotretinoin","Procedure: Leukapheresis","Procedure: Magnetic Resonance Imaging","Drug: Melphalan","Procedure: Multigated Acquisition Scan","Radiation: Radiation Therapy","Procedure: Radionuclide Imaging","Other: Survey Administration","Drug: Temozolomide","Drug: Thiotepa","Drug: Topotecan","Procedure: Tumor Resection","Drug: Vincristine",{"label":119,"type":120,"description":89,"interventionNames":121},"Arm B (Dinutuximab in induction)","EXPERIMENTAL",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117],[123,133,137,144,170,216,233,279,291,299,306,323,329,343,346,378,387,407,425,443,461,474,479,498,530,536,540],{"type":124,"name":125,"description":126,"armGroupLabels":127,"otherNames":128},"PROCEDURE","Biospecimen Collection","Undergo blood and urine sample collection",[87,119],[129,130,131,132],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":124,"name":134,"description":135,"armGroupLabels":136,"otherNames":80},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[87,119],{"type":124,"name":138,"description":139,"armGroupLabels":140,"otherNames":141},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[87,119],[142,143],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":145,"name":146,"description":147,"armGroupLabels":148,"otherNames":149},"DRUG","Carboplatin","Given IV",[87,119],[150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169],"Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo",{"type":145,"name":171,"description":147,"armGroupLabels":172,"otherNames":173},"Cisplatin",[87,119],[174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215],"Abiplatin","Blastolem","Briplatin","CDDP","Cis-diammine-dichloroplatinum","Cis-diamminedichloridoplatinum","Cis-diamminedichloro Platinum (II)","Cis-diamminedichloroplatinum","Cis-dichloroammine Platinum (II)","Cis-platinous Diamine Dichloride","Cis-platinum","Cis-platinum II","Cis-platinum II Diamine Dichloride","Cismaplat","Cisplatina","Cisplatinum","Cisplatyl","Citoplatino","Citosin","Cysplatyna","DDP","Lederplatin","Metaplatin","Neoplatin","Peyrone's Chloride","Peyrone's Salt","Placis","Plastistil","Platamine","Platiblastin","Platiblastin-S","Platinex","Platinol","Platinol- AQ","Platinol-AQ","Platinol-AQ VHA Plus","Platinoxan","Platinum","Platinum Diamminodichloride","Platiran","Platistin","Platosin",{"type":124,"name":217,"description":218,"armGroupLabels":219,"otherNames":220},"Computed Tomography","Undergo CT scan",[87,119],[221,222,223,224,225,226,227,228,229,230,231,232],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":145,"name":234,"description":147,"armGroupLabels":235,"otherNames":236},"Cyclophosphamide",[87,119],[237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Asta B 518","B 518","B-518","B518","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Frindovyx","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR 138719","WR- 138719","WR-138719","WR138719",{"type":280,"name":281,"description":147,"armGroupLabels":282,"otherNames":283},"BIOLOGICAL","Dinutuximab",[87,119],[284,285,286,287,288,289,290],"Ch 14.18UTC","Ch14.18","Dinutuximab Beta","MOAB Ch14.18","monoclonal antibody Ch14.18","Qarziba","Unituxin",{"type":145,"name":292,"description":147,"armGroupLabels":293,"otherNames":294},"Doxorubicin",[87,119],[295,296,297,298],"Adriablastin","Hydroxydaunomycin","Hydroxyl Daunorubicin","Hydroxyldaunorubicin",{"type":124,"name":300,"description":301,"armGroupLabels":302,"otherNames":303},"Echocardiography Test","Undergo ECHO",[87,119],[304,305],"EC","Echocardiography",{"type":145,"name":307,"description":147,"armGroupLabels":308,"otherNames":309},"Etoposide",[87,119],[310,311,312,313,314,315,316,317,318,319,320,321,322],"Demethyl Epipodophyllotoxin Ethylidine Glucoside","EPEG","Lastet","Toposar","Vepesid","VP 16","VP 16-213","VP 16213","VP-16","VP-16-213","VP-16213","VP16","VP16213",{"type":124,"name":324,"description":325,"armGroupLabels":326,"otherNames":327},"FDG-Positron Emission Tomography and Computed Tomography Scan","Undergo FDG PET",[87,119],[328],"FDG PET\u002FCT",{"type":124,"name":330,"description":331,"armGroupLabels":332,"otherNames":333},"Hematopoietic Cell Transplantation","Undergo stem cell infusion",[87,119],[334,335,336,337,338,339,340,341,342],"HCT","Hematopoietic Stem Cell Infusion","HEMATOPOIETIC STEM CELL TRANSPLANT","Hematopoietic Stem Cell Transplantation","HSCT","SCT","Stem Cell Transplant","stem cell transplantation","Stem Cell Transplantation, NOS",{"type":145,"name":344,"description":147,"armGroupLabels":345,"otherNames":80},"Irinotecan",[87,119],{"type":145,"name":347,"description":348,"armGroupLabels":349,"otherNames":350},"Isotretinoin","Given PO",[87,119],[351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377],"13-cis retinoic acid","13-cis-Retinoate","13-cis-Retinoic Acid","13-cis-Vitamin A Acid","13-cRA","Absorica","Accure","Accutane","Amnesteem","cis-Retinoic Acid","Cistane","Claravis","Isotretinoinum","Isotrex","Isotrexin","Myorisan","Neovitamin A","Neovitamin A Acid","Oratane","Retinoicacid-13-cis","Ro 4-3780","Ro-4-3780","Roaccutan","Roaccutane","Roacutan","Sotret","ZENATANE",{"type":124,"name":379,"description":380,"armGroupLabels":381,"otherNames":382},"Leukapheresis","Undergo apheresis",[87,119],[383,384,385,386],"Leukocyte Adsorptive Apheresis","Leukocytopheresis","Therapeutic Leukopheresis","White Blood Cell Reduction Apheresis",{"type":124,"name":388,"description":389,"armGroupLabels":390,"otherNames":391},"Magnetic Resonance Imaging","Undergo MRI",[87,119],[392,393,394,395,396,397,398,399,400,401,402,403,404,405,406],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":145,"name":408,"description":147,"armGroupLabels":409,"otherNames":410},"Melphalan",[87,119],[411,412,413,414,415,416,417,418,419,420,421,422,423,424],"Alanine Nitrogen Mustard","CB-3025","L-PAM","L-Phenylalanine Mustard","L-Sarcolysin","L-Sarcolysin Phenylalanine mustard","L-Sarcolysine","Melphalan for Injection-Hepatic Delivery System","Melphalanum","Phenylalanine Mustard","Phenylalanine Nitrogen Mustard","Sarcoclorin","Sarkolysin","WR-19813",{"type":124,"name":426,"description":427,"armGroupLabels":428,"otherNames":429},"Multigated Acquisition Scan","Undergo MUGA",[87,119],[430,431,432,433,434,435,436,437,438,439,440,441,442],"Blood Pool Scan","Equilibrium Radionuclide Angiography","Gated Blood Pool Imaging","Gated Heart Pool Scan","MUGA","MUGA Scan","Multi-Gated Acquisition Scan","Radionuclide Ventriculogram Scan","Radionuclide Ventriculography","RNV Scan","RNVG","SYMA Scanning","Synchronized Multigated Acquisition Scanning",{"type":444,"name":445,"description":446,"armGroupLabels":447,"otherNames":448},"RADIATION","Radiation Therapy","Undergo radiation therapy",[87,119],[449,450,451,452,453,454,455,456,457,458,459,460],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":124,"name":462,"description":463,"armGroupLabels":464,"otherNames":465},"Radionuclide Imaging","Undergo I-MIBG scan",[87,119],[466,467,468,469,470,471,472,473],"Gamma Scan","NM","Nuclear Medicine","nuclear medicine scan","radioimaging","Radionuclide Scanning","Scan","Scintigraphy",{"type":475,"name":476,"description":477,"armGroupLabels":478,"otherNames":80},"OTHER","Survey Administration","Ancillary studies",[87,119],{"type":145,"name":480,"description":481,"armGroupLabels":482,"otherNames":483},"Temozolomide","Given PO or via NG or G tube",[87,119],[484,485,486,487,488,489,490,491,492,493,494,495,496,497],"CCRG-81045","Gliotem","Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-","M & B 39831","M and B 39831","Methazolastone","RP-46161","SCH 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Meyer",{"facility":2722,"status":1479,"city":2723,"state":2724,"zip":2725,"country":560,"countryCode":561,"cosmosGeoPoint":2726,"geoPoint":2730,"contacts":80},"Saint Vincent Hospital Cancer Center Green Bay","Green Bay","Wisconsin","54301",{"type":563,"coordinates":2727},[2728,2729],-88.01983,44.51916,{"lat":2729,"lon":2728},{"facility":2732,"status":556,"city":2733,"state":2724,"zip":2734,"country":560,"countryCode":561,"cosmosGeoPoint":2735,"geoPoint":2739,"contacts":2740},"University of Wisconsin Carbone Cancer Center - University Hospital","Madison","53792",{"type":563,"coordinates":2736},[2737,2738],-89.40123,43.07305,{"lat":2738,"lon":2737},[2741,2744],{"name":570,"role":571,"phone":2742,"phoneExt":80,"email":2743},"800-622-8922","clinicaltrials@cancer.wisc.edu",{"name":2745,"role":552,"phone":80,"phoneExt":80,"email":80},"Margo L. Hoover-Regan",{"facility":2747,"status":556,"city":2748,"state":2724,"zip":2749,"country":560,"countryCode":561,"cosmosGeoPoint":2750,"geoPoint":2754,"contacts":2755},"Marshfield Medical Center-Marshfield","Marshfield","54449",{"type":563,"coordinates":2751},[2752,2753],-90.1718,44.66885,{"lat":2753,"lon":2752},[2756,2759],{"name":570,"role":571,"phone":2757,"phoneExt":80,"email":2758},"800-782-8581","oncology.clinical.trials@marshfieldresearch.org",{"name":2760,"role":552,"phone":80,"phoneExt":80,"email":80},"Michelle A. Manalang",{"facility":2762,"status":556,"city":2763,"state":2724,"zip":2764,"country":560,"countryCode":561,"cosmosGeoPoint":2765,"geoPoint":2769,"contacts":2770},"Children's Hospital of Wisconsin","Milwaukee","53226",{"type":563,"coordinates":2766},[2767,2768],-87.90647,43.0389,{"lat":2768,"lon":2767},[2771,2774],{"name":570,"role":571,"phone":2772,"phoneExt":80,"email":2773},"414-955-4727","MACCCTO@mcw.edu",{"name":2775,"role":552,"phone":80,"phoneExt":80,"email":80},"Angela Steineck",{"facility":2777,"status":556,"city":2778,"state":2779,"zip":2780,"country":2781,"countryCode":2782,"cosmosGeoPoint":2783,"geoPoint":2787,"contacts":2788},"Sydney Children's Hospital","Randwick","New South Wales","2031","Australia","AU",{"type":563,"coordinates":2784},[2785,2786],151.24895,-33.91439,{"lat":2786,"lon":2785},[2789,2791],{"name":570,"role":571,"phone":2790,"phoneExt":80,"email":80},"(02) 9382-1721",{"name":2792,"role":552,"phone":80,"phoneExt":80,"email":80},"Draga Barbaric",{"facility":2794,"status":556,"city":2795,"state":2779,"zip":2796,"country":2781,"countryCode":2782,"cosmosGeoPoint":2797,"geoPoint":2801,"contacts":2802},"The Children's Hospital at Westmead","Westmead","2145",{"type":563,"coordinates":2798},[2799,2800],150.98768,-33.80383,{"lat":2800,"lon":2799},[2803,2805],{"name":570,"role":571,"phone":2804,"phoneExt":80,"email":80},"61-2-9845 1400",{"name":2806,"role":552,"phone":80,"phoneExt":80,"email":80},"Bhavna Padhye",{"facility":2808,"status":556,"city":2809,"state":2810,"zip":2811,"country":2781,"countryCode":2782,"cosmosGeoPoint":2812,"geoPoint":2816,"contacts":2817},"Queensland Children's Hospital","South Brisbane","Queensland","4101",{"type":563,"coordinates":2813},[2814,2815],153.02049,-27.48034,{"lat":2815,"lon":2814},[2818,2820],{"name":570,"role":571,"phone":2819,"phoneExt":80,"email":80},"61 7 3068 1111",{"name":2821,"role":552,"phone":80,"phoneExt":80,"email":80},"Steven A. Foresto",{"facility":2823,"status":556,"city":2824,"state":2825,"zip":2826,"country":2781,"countryCode":2782,"cosmosGeoPoint":2827,"geoPoint":2831,"contacts":2832},"Royal Children's Hospital","Parkville","Victoria","3052",{"type":563,"coordinates":2828},[2829,2830],144.95,-37.78333,{"lat":2830,"lon":2829},[2833,2836],{"name":570,"role":571,"phone":2834,"phoneExt":80,"email":2835},"61 3 9345 5656","Jordan.Hansford@rch.org.au",{"name":2837,"role":552,"phone":80,"phoneExt":80,"email":80},"Martin A. Campbell",{"facility":2839,"status":556,"city":2840,"state":2841,"zip":2842,"country":2781,"countryCode":2782,"cosmosGeoPoint":2843,"geoPoint":2847,"contacts":2848},"Perth Children's Hospital","Perth","Western Australia","6009",{"type":563,"coordinates":2844},[2845,2846],115.8614,-31.95224,{"lat":2846,"lon":2845},[2849,2850],{"name":570,"role":571,"phone":80,"phoneExt":80,"email":1217},{"name":2851,"role":552,"phone":80,"phoneExt":80,"email":80},"Michelle Ng",{"facility":2853,"status":556,"city":2854,"state":2855,"zip":2856,"country":2857,"countryCode":2858,"cosmosGeoPoint":2859,"geoPoint":2863,"contacts":2864},"Alberta Children's Hospital","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":563,"coordinates":2860},[2861,2862],-114.08529,51.05011,{"lat":2862,"lon":2861},[2865,2868],{"name":570,"role":571,"phone":2866,"phoneExt":80,"email":2867},"403-220-6898","research4kids@ucalgary.ca",{"name":2869,"role":552,"phone":80,"phoneExt":80,"email":80},"Victor A. Lewis",{"facility":2871,"status":556,"city":2872,"state":2855,"zip":2873,"country":2857,"countryCode":2858,"cosmosGeoPoint":2874,"geoPoint":2878,"contacts":2879},"University of Alberta Hospital","Edmonton","T6G 2B7",{"type":563,"coordinates":2875},[2876,2877],-113.46871,53.55014,{"lat":2877,"lon":2876},[2880,2883],{"name":570,"role":571,"phone":2881,"phoneExt":80,"email":2882},"780-407-8798","pedsoncologyresearch@ahs.ca",{"name":2884,"role":552,"phone":80,"phoneExt":80,"email":80},"Sarah J. McKillop",{"facility":2886,"status":556,"city":2887,"state":2888,"zip":2889,"country":2857,"countryCode":2858,"cosmosGeoPoint":2890,"geoPoint":2894,"contacts":2895},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4",{"type":563,"coordinates":2891},[2892,2893],-123.11934,49.24966,{"lat":2893,"lon":2892},[2896,2899],{"name":570,"role":571,"phone":2897,"phoneExt":2898,"email":80},"604-875-2345","6477",{"name":2900,"role":552,"phone":80,"phoneExt":80,"email":80},"Rebecca J. Deyell",{"facility":2902,"status":556,"city":2903,"state":2904,"zip":2905,"country":2857,"countryCode":2858,"cosmosGeoPoint":2906,"geoPoint":2910,"contacts":2911},"CancerCare Manitoba","Winnipeg","Manitoba","R3E 0V9",{"type":563,"coordinates":2907},[2908,2909],-97.14704,49.8844,{"lat":2909,"lon":2908},[2912,2915],{"name":570,"role":571,"phone":2913,"phoneExt":80,"email":2914},"866-561-1026","ctu_web@cancercare.mb.ca",{"name":2916,"role":552,"phone":80,"phoneExt":80,"email":80},"Stephanie M. Villeneuve",{"facility":2918,"status":556,"city":2919,"state":2920,"zip":2921,"country":2857,"countryCode":2858,"cosmosGeoPoint":2922,"geoPoint":2926,"contacts":2927},"Janeway Child Health Centre","St. John's","Newfoundland and Labrador","A1B 3V6",{"type":563,"coordinates":2923},[2924,2925],-52.70931,47.56494,{"lat":2925,"lon":2924},[2928,2931],{"name":570,"role":571,"phone":2929,"phoneExt":80,"email":2930},"709-777-8727","beverlyj.mitchell@easternhealth.ca",{"name":2932,"role":552,"phone":80,"phoneExt":80,"email":80},"Lisa A. Goodyear",{"facility":2934,"status":556,"city":2935,"state":2936,"zip":2937,"country":2857,"countryCode":2858,"cosmosGeoPoint":2938,"geoPoint":2942,"contacts":2943},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8",{"type":563,"coordinates":2939},[2940,2941],-63.57688,44.64269,{"lat":2941,"lon":2940},[2944,2947],{"name":570,"role":571,"phone":2945,"phoneExt":80,"email":2946},"902-470-8520","Research@iwk.nshealth.ca",{"name":2948,"role":552,"phone":80,"phoneExt":80,"email":80},"Chelsea Ash",{"facility":2950,"status":556,"city":2951,"state":2952,"zip":2953,"country":2857,"countryCode":2858,"cosmosGeoPoint":2954,"geoPoint":2958,"contacts":2959},"McMaster Children's Hospital at Hamilton Health Sciences","Hamilton","Ontario","L8N 3Z5",{"type":563,"coordinates":2955},[2956,2957],-79.84963,43.25011,{"lat":2957,"lon":2956},[2960,2962],{"name":570,"role":571,"phone":2961,"phoneExt":80,"email":80},"905-521-2100",{"name":2963,"role":552,"phone":80,"phoneExt":80,"email":80},"Uma H. Athale",{"facility":2965,"status":556,"city":2966,"state":2952,"zip":2967,"country":2857,"countryCode":2858,"cosmosGeoPoint":2968,"geoPoint":2972,"contacts":2973},"Children's Hospital","London","N6A 5W9",{"type":563,"coordinates":2969},[2970,2971],-81.23304,42.98339,{"lat":2971,"lon":2970},[2974,2976],{"name":570,"role":571,"phone":2975,"phoneExt":80,"email":80},"519-685-8306",{"name":2977,"role":552,"phone":80,"phoneExt":80,"email":80},"Shayna M. Zelcer",{"facility":2979,"status":556,"city":2980,"state":2952,"zip":2981,"country":2857,"countryCode":2858,"cosmosGeoPoint":2982,"geoPoint":2986,"contacts":2987},"Children's Hospital of Eastern Ontario","Ottawa","K1H 8L1",{"type":563,"coordinates":2983},[2984,2985],-75.69812,45.41117,{"lat":2985,"lon":2984},[2988,2990],{"name":570,"role":571,"phone":2989,"phoneExt":80,"email":80},"613-737-7600",{"name":2991,"role":552,"phone":80,"phoneExt":80,"email":80},"Donna L. Johnston",{"facility":2993,"status":556,"city":2994,"state":2952,"zip":2995,"country":2857,"countryCode":2858,"cosmosGeoPoint":2996,"geoPoint":3000,"contacts":3001},"Hospital for Sick Children","Toronto","M5G 1X8",{"type":563,"coordinates":2997},[2998,2999],-79.39864,43.70643,{"lat":2999,"lon":2998},[3002,3005],{"name":570,"role":571,"phone":3003,"phoneExt":80,"email":3004},"416-813-7654","ask.CRS@sickkids.ca",{"name":3006,"role":552,"phone":80,"phoneExt":80,"email":80},"Daniel A. Morgenstern",{"facility":3008,"status":556,"city":3009,"state":3010,"zip":3011,"country":2857,"countryCode":2858,"cosmosGeoPoint":3012,"geoPoint":3016,"contacts":3017},"The Montreal Children's Hospital of the MUHC","Montreal","Quebec","H3H 1P3",{"type":563,"coordinates":3013},[3014,3015],-73.58781,45.50884,{"lat":3015,"lon":3014},[3018,3021],{"name":570,"role":571,"phone":3019,"phoneExt":80,"email":3020},"514-412-4445","info@thechildren.com",{"name":3022,"role":552,"phone":80,"phoneExt":80,"email":80},"Stephanie Mourad",{"facility":3024,"status":556,"city":3009,"state":3010,"zip":3025,"country":2857,"countryCode":2858,"cosmosGeoPoint":3026,"geoPoint":3028,"contacts":3029},"Centre Hospitalier Universitaire Sainte-Justine","H3T 1C5",{"type":563,"coordinates":3027},[3014,3015],{"lat":3015,"lon":3014},[3030,3033],{"name":570,"role":571,"phone":3031,"phoneExt":80,"email":3032},"514-345-4931","yvan.samson@umontreal.ca",{"name":3034,"role":552,"phone":80,"phoneExt":80,"email":80},"Monia Marzouki",{"facility":3036,"status":556,"city":3037,"state":3010,"zip":3038,"country":2857,"countryCode":2858,"cosmosGeoPoint":3039,"geoPoint":3043,"contacts":3044},"Centre Hospitalier Universitaire de Sherbrooke-Fleurimont","Sherbrooke","J1H 5N4",{"type":563,"coordinates":3040},[3041,3042],-71.89908,45.40008,{"lat":3042,"lon":3041},[3045,3048],{"name":570,"role":571,"phone":3046,"phoneExt":80,"email":3047},"819-820-6480","crcinformation.chus@ssss.gouv.qc.ca",{"name":3049,"role":552,"phone":80,"phoneExt":80,"email":80},"Josee Brossard",{"facility":3051,"status":1479,"city":3052,"state":3053,"zip":3054,"country":2857,"countryCode":2858,"cosmosGeoPoint":3055,"geoPoint":3059,"contacts":80},"Jim Pattison Children's Hospital","Saskatoon","Saskatchewan","S7N 0W8",{"type":563,"coordinates":3056},[3057,3058],-106.66892,52.13238,{"lat":3058,"lon":3057},{"facility":3061,"status":556,"city":3062,"state":80,"zip":3063,"country":2857,"countryCode":2858,"cosmosGeoPoint":3064,"geoPoint":3068,"contacts":3069},"CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)","Québec","G1V 4G2",{"type":563,"coordinates":3065},[3066,3067],-71.21454,46.81228,{"lat":3067,"lon":3066},[3070,3073],{"name":570,"role":571,"phone":3071,"phoneExt":80,"email":3072},"418-525-4444","rechclinique@crchudequebec.ulaval.ca",{"name":3074,"role":552,"phone":80,"phoneExt":80,"email":80},"Bruno Michon",{"facility":3076,"status":556,"city":3077,"state":3078,"zip":3079,"country":3080,"countryCode":3081,"cosmosGeoPoint":3082,"geoPoint":3086,"contacts":3087},"Starship Children's Hospital","Grafton","Auckland","1145","New Zealand","NZ",{"type":563,"coordinates":3083},[3084,3085],174.76566,-36.86029,{"lat":3085,"lon":3084},[3088,3090],{"name":570,"role":571,"phone":3089,"phoneExt":80,"email":80},"0800 728 436",{"name":3091,"role":552,"phone":80,"phoneExt":80,"email":80},"Andrew C. Wood",{"facility":3093,"status":556,"city":3094,"state":80,"zip":3095,"country":3096,"countryCode":3097,"cosmosGeoPoint":3098,"geoPoint":3102,"contacts":3103},"University Pediatric Hospital","San Juan","00926","Puerto Rico","PR",{"type":563,"coordinates":3099},[3100,3101],-66.10572,18.46633,{"lat":3101,"lon":3100},[3104,3106],{"name":570,"role":571,"phone":3105,"phoneExt":80,"email":80},"787-474-0333",{"name":3107,"role":552,"phone":80,"phoneExt":80,"email":80},"Maria E. Echevarria",{"type":3109,"investigatorFullName":80,"investigatorTitle":80,"investigatorAffiliation":80,"oldNameTitle":80,"oldOrganization":80},"SPONSOR","100529324","dinutuximab-with-chemotherapy-surgery-and-stem-cell-transplantation-for-the-treatment-of-children-with-newly-diagnosed-high-risk-neuroblastoma-100529324",false,"NCT06172296","Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131\n* ≤ 30 years at the time of initial diagnosis with high-risk disease\n* \\* Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines\n\n  * Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:\n\n    * Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification\n    * Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)\n    * Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy\n    * Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)\n* Patients must have a body surface area (BSA) ≥ 0.25 m\\^2\n* No prior anti-cancer therapy except as outlined below:\n\n  * Patients initially recognized to have high-risk disease treated with topotecan\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing, and with consent\n  * Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria\n  * Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis\n* Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Male 0.4 mg\u002FdL and female 0.4mg\u002FdL\n  * 6 months to \\\u003C 1 year: Male 0.5 mg\u002FdL and female 0.5 mg\u002FdL\n  * 1 to \\\u003C 2 years: Male 0.6 mg\u002FdL and female 0.6 mg\u002FdL\n  * 2 to \\\u003C 6 years: Male 0.8 mg\u002FdL and female 0.8 mg\u002FdL\n  * 6 to \\\u003C 10 years: Male 1 mg\u002FdL and female 1 mg\u002FdL\n  * 10 to \\\u003C 13 years: Male 1.2 mg\u002FdL and female 1.2 mg\u002FdL\n  * 13 to \\\u003C 16 years: Male 1.5 mg\u002FdL and female 1.4 mg\u002FdL\n  * ≥ 16 years: Male 1.7 mg\u002FdL and female 1.4 mg\u002FdL\n\n    * The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)\n  * or a 24-hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 or\n  * or a GFR ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n\n    * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \\[ALT\\]) ≤ 10 x ULN\\*\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* \\* Shortening fraction of ≥ 27% by echocardiogram, or\n\n  * Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n* Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:\n\nNo known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and\u002For the apheresis procedure\n\nExclusion Criteria:\n\n* Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features\n* Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features\n* Patients with known bone marrow failure syndromes\n* Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention\u002Ftreatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable\n* Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","ALL","30 Years",{"count":3120,"type":3121},478,"ESTIMATED","INTERVENTIONAL",[3124],"PHASE3","This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.",[3127,3128],"Ganglioneuroblastoma, Nodular","Neuroblastoma","2026-08-22",{"date":3131,"type":3132},"2026-08-25","ACTUAL",{"date":3134,"type":3132},"2024-04-19",{"date":3136,"type":3121},"2029-12-31",{"name":5,"class":6},179]