[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100255543":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":54,"centralContacts":58,"locations":67,"responsibleParty":85,"collaborators":26,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":26,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":26,"maxAge":95,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients Treated for Neuroblastoma","EXPERIMENTAL","Consolidation course #1 consists of thiotepa and cyclophosphamide followed by a PBSC rescue. Consolidation course #2 consists of melphalan, etoposide and carboplatin followed by a second PBSC rescue. Post infusion, patients will receive Granulocyte-Colony Stimulating Factor beginning on Day 0 of each consolidation course.",[13,14,15,16,17,18,19],"Drug: Thiotepa","Drug: Cyclophosphamide","Drug: Melphalan","Drug: Etoposide","Drug: Carboplatin","Biological: Autologous Stem Cell Infusion","Biological: Granulocyte colony stimulating factor",[21,27,31,35,39,43,48],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Thiotepa","Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cyclophosphamide","Cyclophosphamide by IV once daily for 4 doses on Days -5, -4, -3 and -2. Given as part of Consolidation Course #1 along with Thiotepa.",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Melphalan","Melphalan by IV once daily for 3 doses on Days -8, -7, and -6. Given as part of Consolidation Course #2 along with Etoposide and Carboplatin.",[9],{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"Etoposide","Etoposide by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Melphalan and Carboplatin.",[9],{"type":22,"name":40,"description":41,"armGroupLabels":42,"otherNames":26},"Carboplatin","Carboplatin by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Etoposide and Melphalan.",[9],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":26},"BIOLOGICAL","Autologous Stem Cell Infusion","On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.",[9],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Granulocyte colony stimulating factor","Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF SQ or IV (SQ preferred) 5 micrograms\u002Fkg once daily and continuing once daily until post-nadir ANC \\> 2000\u002FμL for 3 consecutive days.",[9],[53],"G-CSF",[55],{"name":56,"affiliation":5,"role":57},"Ashish Gupta, MBBS, MPH","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":26,"email":63},"Lisa Burke","CONTACT","612-273-8482","lburke3@Fairview.org",{"name":56,"role":61,"phone":65,"phoneExt":26,"email":66},"612-626-2961","stef0030@umn.edu",[68],{"facility":5,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-93.26384,44.97997,{"lat":79,"lon":78},[82,84],{"name":83,"role":61,"phone":62,"phoneExt":26,"email":63},"Lisa Burke, RN",{"name":56,"role":57,"phone":26,"phoneExt":26,"email":26},{"type":86,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100255543","phase-2-myeloablative-consolidation-therapy-and-tandem-autologous-stem-cell-rescue-in-patients-with-high-risk-neuroblastoma-100255543",false,"NCT02605421","Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma","Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma","* Less than 30 years of age at diagnosis of neuroblastoma\n* End of Induction disease evaluation demonstrating CR, PR, MR or SD\n* Hematopoietic Recovery from last induction course of chemotherapy\n* No uncontrolled infection\n* Minimum frozen PBSCs of 2 x 10\\^6 CD34 cells\u002Fkg for each transplant are mandatory and a PBSC of 2 x 10\\^6 CD34 cells\u002Fkg for back-up are strongly recommended (thus, PBSC of no less than 6 x 10\\^6 CD34 cells\u002Fkg is encouraged). These must all be collected prior to the initiation of consolidation.\n* Adequate organ function defined as:\n\n  * Hepatic: AST and ALT \\\u003C 3 x upper limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, \\> 1.0 1.5 x baseline if baseline was abnormal\n  * Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure\n  * Pulmonary: no evidence of dyspnea at rest and norequirement for supplemental oxygen\n  * Renal: Creatinine clearance or GFR \\> 60 mL\u002Fmin\u002F1.73m\\^2. If a creatinine clearance is performed at end induction and the result is \\\u003C 100 ml\u002Fmin\u002F1.73m\\^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of \\\u003C 100 ml\u002Fmin\u002F1.73m\\^2\n* Recovery from acute toxicities of last cycle of induction chemotherapy\n* Appropriate written consent - adult or parent\u002Fguardian if patient is \\\u003C 18 years of age and minor information sheet if patient is \\> 8 years of age","ALL","30 Years",{"count":97,"type":98},12,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","This is a phase II single center study to administer two courses of myeloablative consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC) rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy (independent of this study). Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.",[104],"Neuroblastoma",[106,104,107,108,109,110,111],"High-risk neuroblastoma","Myeloablative chemotherapy","Myeloablative consolidation chemotherapy","Autologous peripheral blood stem cell rescue","PBSC","Autologous stem cell rescue","2025-10-20",{"date":114,"type":115},"2025-10-21","ACTUAL",{"date":117,"type":115},"2016-06",{"date":119,"type":98},"2026-12",{"name":5,"class":6},1]