[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100252047":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":51,"centralContacts":56,"locations":63,"responsibleParty":489,"collaborators":493,"id":504,"slug":505,"hasResults":506,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":506,"sex":512,"minAge":61,"maxAge":513,"enrollmentInfo":514,"targetDuration":61,"studyType":517,"phases":518,"briefSummary":520,"conditions":521,"keywords":61,"overallStatus":66,"whyStopped":61,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":532},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Immunotherapy without DFMO","ACTIVE_COMPARATOR","One of the following drugs will be chosen for each subject based on molecular guided results: ceritinib, dasatinib, sorafenib or vorinostat. This will be followed standard immunotherapy with Dinutuximab\u002FGM-CSF\u002FIL-2 and isotretinoin. At the end of immunotherapy, DFMO will be given to all subjects BID for 730 days.",[13,14,15,16],"Drug: Ceritinib","Drug: dasatinib","Drug: sorafenib","Drug: vorinostat",{"label":18,"type":10,"description":19,"interventionNames":20},"Standard Immunotherapy with DFMO","One of the following drugs will be chosen for each subject based on molecular guided results: ceritinib, dasatinib, sorafenib or vorinostat. This will be followed standard immunotherapy with Dinutuximab\u002FGM-CSF\u002FIL-2 and isotretinoin PLUS 1000mg\u002Fm2 BID of DFMO. At the end of immunotherapy, all subjects will go on to receive DFMO BID for 730 days.",[13,14,15,16,21],"Drug: DFMO",[23,30,35,40,45],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Ceritinib","One of the following drugs will be chosen for each subject based on molecular guided results: Ceritinib, dasatinib, sorafenib or vorinostat. This will be followed by consolidation, immunotherapy +\u002F- DFMO, and then all subjects will receive DFMO for 2 years as maintenance.",[18,9],[29],"Zykadia",{"type":24,"name":31,"description":26,"armGroupLabels":32,"otherNames":33},"dasatinib",[18,9],[34],"Sprycel",{"type":24,"name":36,"description":26,"armGroupLabels":37,"otherNames":38},"sorafenib",[18,9],[39],"Nexavar",{"type":24,"name":41,"description":26,"armGroupLabels":42,"otherNames":43},"vorinostat",[18,9],[44],"ZOLINZA",{"type":24,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DFMO","DFMO will be given to Arm B during immunotherapy and then for 2 years as maintenance to all subjects completing immunotherapy.",[18],[50],"Eflornithine, α-difluoromethylornithine",[52],{"name":53,"affiliation":54,"role":55},"Giselle Sholler, MD","Beat Childhood Cancer","STUDY_CHAIR",[57],{"name":58,"role":59,"phone":60,"phoneExt":61,"email":62},"BCC Enroll","CONTACT","7175310003",null,"BCCEnroll@pennstatehealth.psu.edu",[64,85,101,117,132,148,164,179,194,210,226,237,247,263,279,295,305,320,330,346,362,378,394,410,425,443,459,474],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"University of Alabama\u002FChildren's of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-86.80249,33.52066,{"lat":76,"lon":75},[79,82],{"name":80,"role":59,"phone":61,"phoneExt":61,"email":81},"Bridget Tate","btate@peds.uab.edu",{"name":83,"role":84,"phone":61,"phoneExt":61,"email":61},"Elizabeth Alva","PRINCIPAL_INVESTIGATOR",{"facility":86,"status":66,"city":87,"state":88,"zip":89,"country":70,"countryCode":71,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Arkansas Children's Hospital","Little Rock","Arkansas","72202",{"type":73,"coordinates":91},[92,93],-92.28959,34.74648,{"lat":93,"lon":92},[96,99],{"name":97,"role":59,"phone":61,"phoneExt":61,"email":98},"Susan Hall","HallSF@archildrens.org",{"name":100,"role":84,"phone":61,"phoneExt":61,"email":61},"Kevin Bielamowicz",{"facility":102,"status":66,"city":103,"state":104,"zip":105,"country":70,"countryCode":71,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"UCSF Benioff Children's Hospital Oakland","Oakland","California","94609",{"type":73,"coordinates":107},[108,109],-122.2708,37.80437,{"lat":109,"lon":108},[112,115],{"name":113,"role":59,"phone":61,"phoneExt":61,"email":114},"Group Contact","PedOncRschOAK@ucsf.edu",{"name":116,"role":84,"phone":61,"phoneExt":61,"email":61},"Jennifer Michlitsch",{"facility":118,"status":66,"city":119,"state":104,"zip":120,"country":70,"countryCode":71,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Rady Children's Hospital","San Diego","92123",{"type":73,"coordinates":122},[123,124],-117.16472,32.71571,{"lat":124,"lon":123},[127,130],{"name":128,"role":59,"phone":61,"phoneExt":61,"email":129},"Megan Saenz","msaenz@rchsd.org",{"name":131,"role":84,"phone":61,"phoneExt":61,"email":61},"William Roberts",{"facility":133,"status":66,"city":134,"state":135,"zip":136,"country":70,"countryCode":71,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Connecticut Children's Hospital","Hartford","Connecticut","06106",{"type":73,"coordinates":138},[139,140],-72.68509,41.76371,{"lat":140,"lon":139},[143,146],{"name":144,"role":59,"phone":61,"phoneExt":61,"email":145},"Adam Barselau","Abarselau@connecticutchildrens.org",{"name":147,"role":84,"phone":61,"phoneExt":61,"email":61},"Michael Isakoff",{"facility":149,"status":66,"city":150,"state":151,"zip":152,"country":70,"countryCode":71,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Nicklaus Children's Miami","Miami","Florida","33155",{"type":73,"coordinates":154},[155,156],-80.19366,25.77427,{"lat":156,"lon":155},[159,162],{"name":160,"role":59,"phone":61,"phoneExt":61,"email":161},"Aixa Guadarrama","Aixa.Guadarrama@Nicklaushealth.org",{"name":163,"role":84,"phone":61,"phoneExt":61,"email":61},"Guillermo De Angulo",{"facility":165,"status":66,"city":166,"state":151,"zip":167,"country":70,"countryCode":71,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Arnold Palmer Hospital for Children","Orlando","32806",{"type":73,"coordinates":169},[170,171],-81.37924,28.53834,{"lat":171,"lon":170},[174,177],{"name":175,"role":59,"phone":61,"phoneExt":61,"email":176},"Marie Frankos","marie.frankos@orlandohealth.com",{"name":178,"role":84,"phone":61,"phoneExt":61,"email":61},"Jamie Libes-Bander",{"facility":180,"status":66,"city":181,"state":151,"zip":182,"country":70,"countryCode":71,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"St. Joseph's Children's Hospital","Tampa","33614",{"type":73,"coordinates":184},[185,186],-82.45843,27.94752,{"lat":186,"lon":185},[189,192],{"name":190,"role":59,"phone":61,"phoneExt":61,"email":191},"Jennifer Manns, RN","jennifer.manns@baycare.org",{"name":193,"role":84,"phone":61,"phoneExt":61,"email":61},"Don Eslin",{"facility":195,"status":66,"city":196,"state":197,"zip":198,"country":70,"countryCode":71,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Augusta University Health","Augusta","Georgia","30912",{"type":73,"coordinates":200},[201,202],-81.97484,33.47097,{"lat":202,"lon":201},[205,208],{"name":206,"role":59,"phone":61,"phoneExt":61,"email":207},"Kimberly Gray","kigray@augusta.edu",{"name":209,"role":84,"phone":61,"phoneExt":61,"email":61},"Coleen McDonough",{"facility":211,"status":66,"city":212,"state":213,"zip":214,"country":70,"countryCode":71,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Kapiolani Medical Center for Women and Children","Honolulu","Hawaii","96813",{"type":73,"coordinates":216},[217,218],-157.85833,21.30694,{"lat":218,"lon":217},[221,224],{"name":222,"role":59,"phone":61,"phoneExt":61,"email":223},"Andrea Siu","andrea.siu@kapiolani.org",{"name":225,"role":84,"phone":61,"phoneExt":61,"email":61},"Randal Wada",{"facility":227,"status":228,"city":229,"state":230,"zip":231,"country":70,"countryCode":71,"cosmosGeoPoint":232,"geoPoint":236,"contacts":61},"St. Lukes","COMPLETED","Boise","Idaho","83712",{"type":73,"coordinates":233},[234,235],-116.20345,43.6135,{"lat":235,"lon":234},{"facility":238,"status":228,"city":239,"state":240,"zip":241,"country":70,"countryCode":71,"cosmosGeoPoint":242,"geoPoint":246,"contacts":61},"Advocate Aurora Research Institute","Chicago","Illinois","60453",{"type":73,"coordinates":243},[244,245],-87.65005,41.85003,{"lat":245,"lon":244},{"facility":248,"status":66,"city":249,"state":250,"zip":251,"country":70,"countryCode":71,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Norton Children's Research Institute\u002FAffiliated with University of Louisville School of Medicine","Louisville","Kentucky","40202",{"type":73,"coordinates":253},[254,255],-85.75941,38.25424,{"lat":255,"lon":254},[258,261],{"name":259,"role":59,"phone":61,"phoneExt":61,"email":260},"Jennifer Miller","Jennifer.Miller4@nortonhealthcare.org",{"name":262,"role":84,"phone":61,"phoneExt":61,"email":61},"Michael Ferguson",{"facility":264,"status":66,"city":265,"state":266,"zip":267,"country":70,"countryCode":71,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Helen DeVos Children's Hospital","Grand Rapids","Michigan","49503",{"type":73,"coordinates":269},[270,271],-85.66809,42.96336,{"lat":271,"lon":270},[274,277],{"name":275,"role":59,"phone":61,"phoneExt":61,"email":276},"Mary Beth Readwin","mary.readwin2@corewellhealth.org",{"name":278,"role":84,"phone":61,"phoneExt":61,"email":61},"David Hoogstra",{"facility":280,"status":66,"city":281,"state":282,"zip":283,"country":70,"countryCode":71,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"Children's Hospital and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"type":73,"coordinates":285},[286,287],-93.26384,44.97997,{"lat":287,"lon":286},[290,293],{"name":291,"role":59,"phone":61,"phoneExt":61,"email":292},"Pauline Mitby","pauline.mitby@childrensmn.org",{"name":294,"role":84,"phone":61,"phoneExt":61,"email":61},"Jawhar Rawwas",{"facility":296,"status":228,"city":297,"state":298,"zip":299,"country":70,"countryCode":71,"cosmosGeoPoint":300,"geoPoint":304,"contacts":61},"Children's Mercy Hospitals and Clinics","Kansas City","Missouri","64108",{"type":73,"coordinates":301},[302,303],-94.57857,39.09973,{"lat":303,"lon":302},{"facility":306,"status":66,"city":307,"state":298,"zip":308,"country":70,"countryCode":71,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Cardinal Glennon Children's Medical Center","St Louis","63104",{"type":73,"coordinates":310},[311,312],-90.19789,38.62727,{"lat":312,"lon":311},[315,318],{"name":316,"role":59,"phone":61,"phoneExt":61,"email":317},"Gina Martin, RN","gina.martin@health.slu.edu",{"name":319,"role":84,"phone":61,"phoneExt":61,"email":61},"William Ferguson",{"facility":321,"status":228,"city":322,"state":323,"zip":324,"country":70,"countryCode":71,"cosmosGeoPoint":325,"geoPoint":329,"contacts":61},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":73,"coordinates":326},[327,328],-74.04347,40.88593,{"lat":328,"lon":327},{"facility":331,"status":66,"city":332,"state":333,"zip":334,"country":70,"countryCode":71,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Levine Children's Hospital","Charlotte","North Carolina","28204",{"type":73,"coordinates":336},[337,338],-80.84313,35.22709,{"lat":338,"lon":337},[341,344],{"name":342,"role":59,"phone":61,"phoneExt":61,"email":343},"Jontyce Green","Jontyce.Green@advocatehealth.org",{"name":345,"role":84,"phone":61,"phoneExt":61,"email":61},"Thomas Russell",{"facility":347,"status":66,"city":348,"state":349,"zip":350,"country":70,"countryCode":71,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"Randall Children's Hospital","Portland","Oregon","97227",{"type":73,"coordinates":352},[353,354],-122.67621,45.52345,{"lat":354,"lon":353},[357,360],{"name":358,"role":59,"phone":61,"phoneExt":61,"email":359},"Aaron White","AJWHITE@lhs.org",{"name":361,"role":84,"phone":61,"phoneExt":61,"email":61},"Jason Glover",{"facility":363,"status":66,"city":364,"state":365,"zip":366,"country":70,"countryCode":71,"cosmosGeoPoint":367,"geoPoint":371,"contacts":372},"Penn State Milton S. Hershey Medical Center and Children's Hospital","Hershey","Pennsylvania","17033",{"type":73,"coordinates":368},[369,370],-76.65025,40.28592,{"lat":370,"lon":369},[373,376],{"name":374,"role":59,"phone":61,"phoneExt":61,"email":375},"Penn State Clinical Trials","ExtractClinicalTrials@pennstatehealth.psu.edu",{"name":377,"role":84,"phone":61,"phoneExt":61,"email":61},"Valerie Brown",{"facility":379,"status":66,"city":380,"state":381,"zip":382,"country":70,"countryCode":71,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":73,"coordinates":384},[385,386],-79.93275,32.77632,{"lat":386,"lon":385},[389,392],{"name":390,"role":59,"phone":61,"phoneExt":61,"email":391},"Shanta Salzar, MD","salzers@musc.edu",{"name":393,"role":84,"phone":61,"phoneExt":61,"email":61},"Jaqueline Kraveka",{"facility":395,"status":66,"city":396,"state":397,"zip":398,"country":70,"countryCode":71,"cosmosGeoPoint":399,"geoPoint":403,"contacts":404},"Dell Children's Blood and Cancer Center","Austin","Texas","78723",{"type":73,"coordinates":400},[401,402],-97.74306,30.26715,{"lat":402,"lon":401},[405,408],{"name":406,"role":59,"phone":61,"phoneExt":61,"email":407},"Rhea Robinson","rmrobinson@ascension.org",{"name":409,"role":84,"phone":61,"phoneExt":61,"email":61},"Virginia Harrod",{"facility":411,"status":66,"city":412,"state":397,"zip":413,"country":70,"countryCode":71,"cosmosGeoPoint":414,"geoPoint":418,"contacts":419},"Children's Medical Center","Dallas","75235",{"type":73,"coordinates":415},[416,417],-96.80667,32.78306,{"lat":417,"lon":416},[420,423],{"name":421,"role":59,"phone":61,"phoneExt":61,"email":422},"Rachel Nam","rachel.nam@childrens.com",{"name":424,"role":84,"phone":61,"phoneExt":61,"email":61},"Tanya Watt",{"facility":426,"status":66,"city":427,"state":428,"zip":429,"country":430,"countryCode":431,"cosmosGeoPoint":432,"geoPoint":436,"contacts":437},"Alberta Children's Hospital","Calgary","Alberta","AB T3B 6A8","Canada","CA",{"type":73,"coordinates":433},[434,435],-114.08529,51.05011,{"lat":435,"lon":434},[438,441],{"name":439,"role":59,"phone":61,"phoneExt":61,"email":440},"Sherry Qian","Sherry.Qian@albertahealthservices.ca",{"name":442,"role":84,"phone":61,"phoneExt":61,"email":61},"Melanie Finkbeiner",{"facility":444,"status":66,"city":445,"state":446,"zip":447,"country":430,"countryCode":431,"cosmosGeoPoint":448,"geoPoint":452,"contacts":453},"CHU Sainte-Justine","Montreal","Quebec","QC H3S 2G4",{"type":73,"coordinates":449},[450,451],-73.58781,45.50884,{"lat":451,"lon":450},[454,457],{"name":455,"role":59,"phone":61,"phoneExt":61,"email":456},"Guillaume Leblanc","guillaume.leblanc.hsj@ssss.gouv.qc.ca",{"name":458,"role":84,"phone":61,"phoneExt":61,"email":61},"Pierre Tiera",{"facility":460,"status":66,"city":461,"state":446,"zip":462,"country":430,"countryCode":431,"cosmosGeoPoint":463,"geoPoint":467,"contacts":468},"CHUQ","Québec","QC G1V 4W6",{"type":73,"coordinates":464},[465,466],-71.21454,46.81228,{"lat":466,"lon":465},[469,472],{"name":470,"role":59,"phone":61,"phoneExt":61,"email":471},"Valerie-Eve Julien","Valerie-Eve.Julien@crchudequebec.ulaval.ca",{"name":473,"role":84,"phone":61,"phoneExt":61,"email":61},"Bruno Michon",{"facility":475,"status":66,"city":476,"state":446,"zip":477,"country":430,"countryCode":431,"cosmosGeoPoint":478,"geoPoint":482,"contacts":483},"CIUSSS de l'Estrie-CHUS","Sherbrooke","QC J1H 5H3",{"type":73,"coordinates":479},[480,481],-71.89908,45.40008,{"lat":481,"lon":480},[484,487],{"name":485,"role":59,"phone":61,"phoneExt":61,"email":486},"Cassandra Leblanc-Desrochers","cassandra.leblanc-desrochers.ciussse-chus@ssss.gouv.qc.ca",{"name":488,"role":84,"phone":61,"phoneExt":61,"email":61},"Josee Brossard",{"type":490,"investigatorFullName":491,"investigatorTitle":492,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"SPONSOR_INVESTIGATOR","Giselle Sholler","Beat Childhood Cancer Chair",[494,497,499,501],{"name":495,"class":496},"Dell, Inc.","INDUSTRY",{"name":498,"class":6},"Beat NB Cancer Foundation",{"name":500,"class":496},"K C Pharmaceuticals Inc.",{"name":502,"class":503},"Team Parker for Life","UNKNOWN","100252047","phase-2-pediatric-precision-laboratory-advanced-neuroblastoma-therapy-100252047",false,"NCT02559778","Pediatric Precision Laboratory Advanced Neuroblastoma Therapy","A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma","PEDS-PLAN","Part A- CLOSED:\n\n1. Diagnosis: Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria:\n\n   a) Subjects with newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following: i. Age \\> 18 months (\\> 547 days) regardless of biologic features or ii. Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and\u002For DNA index = 1) or iii. MYCN amplification (\\> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.\n\n   b) Subjects with newly diagnosed neuroblastoma with INSS Stage 3 are eligible with the following: i. MYCN amplification (\\> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or ii. Age \\> 18 months (\\> 547 days) with unfavorable pathology, regardless of MYCN status.\n\n   c) Subjects with newly diagnosed neuroblastoma with INSS Stage 2A\u002F2B with MYCN amplification (\\> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.\n2. Subjects must be age ≤ 21 years at initial diagnosis\n3. Subjects must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and\u002For no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology.\n4. Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.\n5. Ability to tolerate PBSC collection: No known contraindication to PBSC collection. Examples of contraindications would include a weight or size less than that determined to be feasible at the collecting institution, 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\n   Part A and B both- Part A CLOSED, Part B- OPEN:\n6. Adequate Cardiac Function Defined As:\n\n   1. Shortening fraction of ≥ 27% by echocardiogram, or\n   2. Ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram.\n7. Adequate liver function must be demonstrated, defined as:\n\n   c. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND d. ALT (SGPT) \\\u003C 10 x upper limit of normal (ULN) for age\n8. Subjects must have adequate renal function defined as a serum creatinine based on age\u002Fgender as follows:\n\n   Age Maximum Serum Creatinine (mg\u002FdL) Male Female 1 month to \\\u003C 6 months 0.4 0.4 6 months to \\\u003C 1 year 0.5 0.5 1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 year 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n\n   ≥ 16 years 1.7 1.4\n9. A negative serum pregnancy test is required for female participants of child bearing potential (≥13 years of age or after onset of menses)\n10. Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\"the pill\"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.\n11. Informed Consent: All subjects and\u002For legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\n    Part B- OPEN:\n12. All patients must have a pathologically confirmed diagnosis of neuroblastoma, be age ≤ 21 years at initial diagnosis, and classified as high risk by the criteria used by COG or SIOPEN at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and\u002For relapsed) to high risk neuroblastoma are also eligible.\n13. Previous Therapy- subjects must fit into one of the strata categories listed in section 10.5 to be eligible to enroll on Part B of this study.\n14. Pre-enrollment tumor survey:\n\n    Prior to enrollment on Part B, a determination of mandatory disease staging must be performed. Tumor imaging studies including CT or MRI, MIBG or PET, and VMA\u002FHVA (PET scan should be done for patients with prior disease that was MIBG non-avid). Bone marrow aspirates and biopsies are required.\n\n    This disease assessment is required for eligibility and should be done preferably within 2 weeks, but must be done within a maximum of 4 weeks before first dose of study drug.\n15. Timing- Enrollment to occur prior to Day + 120 post-transplant, preferably when the subject is within 28 days after completing local radiation therapy (if given).\n\nExclusion Criteria (Part A and B)\n\n1. Subjects who are 12-18 months of age with INSS Stage 4 and all stage 3 subjects with favorable biologic features (ie, nonamplified MYCN, favorable pathology, and DNA index \\> 1) are not eligible.\n2. Lactating females are not eligible unless they have agreed not to breastfeed their infants.\n3. Subjects receiving any investigational drug concurrently.\n4. Subjects with any other medical condition, including but not limited to malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study","ALL","22 Years",{"count":515,"type":516},500,"ESTIMATED","INTERVENTIONAL",[519],"PHASE2","A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.",[522],"Neuroblastoma","2026-04-24",{"date":525,"type":526},"2026-04-28","ACTUAL",{"date":528,"type":526},"2015-09",{"date":530,"type":516},"2035-09",{"name":491,"class":6},28]