[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480375":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":131,"centralContacts":137,"locations":143,"responsibleParty":302,"collaborators":304,"id":308,"slug":309,"hasResults":310,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":122,"eligibilityCriteria":314,"healthyVolunteers":310,"sex":315,"minAge":122,"maxAge":316,"enrollmentInfo":317,"targetDuration":122,"studyType":320,"phases":321,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":146,"whyStopped":122,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8,22,27,33,38],{"label":9,"type":10,"description":11,"interventionNames":12},"Stratum S-2","EXPERIMENTAL","Patients with Sonic Hedgehog subgroup 2 (SHH-2), 0-2.99 years, or M0 and 3-4.99 years, will receive systemic high-dose methotrexate (HD-MTX) and conventional chemotherapy.\n\nInterventions: Surgery, Methotrexate, Cisplatin, Vincristine, Cyclophosphamide, Carboplatin, Topotecan, Pegfilgrastim, Filgrastim",[13,14,15,16,17,18,19,20,21],"Procedure: Surgical resection","Drug: Methotrexate","Drug: Cisplatin","Drug: Vincristine","Drug: Cyclophosphamide","Drug: Carboplatin","Drug: Topotecan","Drug: Pegfilgrastim","Drug: Filgrastim",{"label":23,"type":10,"description":24,"interventionNames":25},"Stratum S-1","Patients with SHH-1, SHH-3, SHH-4, or SHH-Not otherwise specified (NOS), 0-2.99 years, will receive intraventricular methotrexate (IVT-MTX) in parallel with systemic HD-MTX and conventional chemotherapy.\n\nInterventions: Surgery, Methotrexate, Cisplatin, Vincristine, Cyclophosphamide, Carboplatin, Topotecan, Pegfilgrastim, Filgrastim",[13,26,15,16,17,18,19,20,21,14],"Procedure: Ommaya\u002FVPS",{"label":28,"type":10,"description":29,"interventionNames":30},"Stratum N","Patients with Medulloblastoma (MB) group 3 or group 4 (G3\u002FG4) or MB \\[including Non-WNT non-SHH medulloblastoma (NWNS) NOS or otherwise indeterminate cases\\] (0-2.99 years) will receive systemic HD-MTX and conventional chemotherapy only for radiation delaying purposes. At 3 years of age, these patients will receive risk-stratified craniospinal irradiation (CSI).\n\nInterventions: Surgery, Methotrexate, Cisplatin, Vincristine, Cyclophosphamide, Carboplatin, Topotecan, Etoposide, Pegfilgrastim, Filgrastim, Radiation",[13,14,15,16,17,18,19,31,20,21,32],"Drug: Etoposide","Radiation: Irradiation",{"label":34,"type":10,"description":35,"interventionNames":36},"Cognitive Study Group I (educational video and games)","Educational video and games",[37],"Other: Educational and Media Intervention",{"label":39,"type":40,"description":41,"interventionNames":42},"Cognitive Study Group II (standard-of-care control)","ACTIVE_COMPARATOR","Standard-of-care (SOC) followed by educational video and games",[43],"Other: SOC, Educational and Media Intervention",[45,52,57,65,72,77,82,87,92,98,104,111,118,123,127],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"PROCEDURE","Surgical resection","All participants enrolled will undergo surgical resection prior to treatment. The maximal resection that can be achieved without undue risk to the patient will be attempted, with decisions about feasibility and extent of resection left to the discretion of the neurosurgeon. In instances where an STR is the best extent of resection achieved prior to start of therapy, a \"second-look\" surgery may be performed between cycles of chemotherapy after discussion with the principal investigator.",[28,23,9],[51],"surgical management",{"type":46,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Ommaya\u002FVPS","All participants enrolled on S-1 will undergo",[23],[51],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DRUG","Methotrexate","Route of administration: Intravenously (IV)",[28,9],[63,64],"MTX","amethopterin",{"type":58,"name":66,"description":60,"armGroupLabels":67,"otherNames":68},"Cisplatin",[28,23,9],[69,70,71],"CDDP","cis-DDP","Platinol-AQ®",{"type":58,"name":73,"description":60,"armGroupLabels":74,"otherNames":75},"Vincristine",[28,23,9],[76],"Oncovin®",{"type":58,"name":78,"description":60,"armGroupLabels":79,"otherNames":80},"Cyclophosphamide",[28,23,9],[81],"Cytoxan®",{"type":58,"name":83,"description":60,"armGroupLabels":84,"otherNames":85},"Carboplatin",[28,23,9],[86],"Paraplatin®",{"type":58,"name":88,"description":60,"armGroupLabels":89,"otherNames":90},"Topotecan",[28,23,9],[91],"Hycamtin®",{"type":58,"name":93,"description":60,"armGroupLabels":94,"otherNames":95},"Etoposide",[28],[96,97],"VP-16","Vepesid®",{"type":58,"name":99,"description":100,"armGroupLabels":101,"otherNames":102},"Pegfilgrastim","Route of administration: subcutaneous (SQ)",[28,23,9],[103],"Udenyca®",{"type":58,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Filgrastim","Route of administration: subcutaneous (SQ) or Intravenously (IV)",[28,23,9],[109,110],"GCSF","Neupogen®",{"type":112,"name":113,"description":114,"armGroupLabels":115,"otherNames":116},"RADIATION","Irradiation","All participants in stratum N will undergo craniospinal irradiation (CSI) with boost to the primary tumor site once they reach 36 months of age. The dose given is based on the molecular risk group and disease response to chemotherapy as noted in the arm descriptions. The type of radiation used includes conformal radiation therapy (photons) or intensity modulated radiation therapy (IMRT) or proton beam therapy.",[28],[117],"Radiotherapy",{"type":6,"name":119,"description":120,"armGroupLabels":121,"otherNames":122},"Educational and Media Intervention","Participants watch a 75-minute caregiver education video program and receive access to interactive games on a smartphone or tablet throughout the optional cognitive study.",[34],null,{"type":6,"name":124,"description":125,"armGroupLabels":126,"otherNames":122},"SOC, Educational and Media Intervention","Standard-of-care (SOC) treatment during main cognitive study. After the one-year serial cognitive evaluation, participants will be offered participation in the cognitive study group I intervention.",[39],{"type":58,"name":59,"description":128,"armGroupLabels":129,"otherNames":130},"Route of administration: Intravenously (IV) \\& Intra Ventricular (IVT)",[23],[63,64],[132,135],{"name":133,"affiliation":5,"role":134},"Giles W. Robinson, MD","PRINCIPAL_INVESTIGATOR",{"name":136,"affiliation":5,"role":134},"Aditi Bagchi, MD, PhD",[138],{"name":139,"role":140,"phone":141,"phoneExt":122,"email":142},"Tabatha E. Doyle, RN","CONTACT","901-595-2544","tabatha.doyle@stjude.org",[144,164,180,195,211,227,240,256,271,286],{"facility":145,"status":146,"city":147,"state":148,"zip":149,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":157,"contacts":158},"Lucille Packard Children's Hospital Stanford","RECRUITING","Palo Alto","California","94304","United States","US",{"type":153,"coordinates":154},"Point",[155,156],-122.14302,37.44188,{"lat":156,"lon":155},[159,163],{"name":160,"role":140,"phone":161,"phoneExt":122,"email":162},"Sonia Partap, MD, MS,","650-723-5535","spartap@stanford.edu",{"name":160,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":165,"status":146,"city":166,"state":167,"zip":168,"country":150,"countryCode":151,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Orlando Health Arnold Palmer Hospital for Children","Orlando","Florida","32806",{"type":153,"coordinates":170},[171,172],-81.37924,28.53834,{"lat":172,"lon":171},[175,179],{"name":176,"role":140,"phone":177,"phoneExt":122,"email":178},"Avery Wright, DO","321-841-8588","Avery.Wright@orlandohealth.com",{"name":176,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":181,"status":146,"city":182,"state":167,"zip":183,"country":150,"countryCode":151,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"St. Joseph's Children's Hospital","Tampa","33607",{"type":153,"coordinates":185},[186,187],-82.45843,27.94752,{"lat":187,"lon":186},[190,194],{"name":191,"role":140,"phone":192,"phoneExt":122,"email":193},"Trisha Larkin, MD","813-321-6820","Trisha.Larkin@baycare.org",{"name":191,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":196,"status":146,"city":197,"state":198,"zip":199,"country":150,"countryCode":151,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"C.S. MOTT Children's Hospital, University of Michigan","Ann Arbor","Michigan","48109",{"type":153,"coordinates":201},[202,203],-83.74088,42.27756,{"lat":203,"lon":202},[206,210],{"name":207,"role":140,"phone":208,"phoneExt":122,"email":209},"Santhosh Upadhyaya, MD","734-615-7920","saupadhy@med.umich.edu",{"name":207,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":212,"status":146,"city":213,"state":214,"zip":215,"country":150,"countryCode":151,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Children's Hospital and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"type":153,"coordinates":217},[218,219],-93.26384,44.97997,{"lat":219,"lon":218},[222,226],{"name":223,"role":140,"phone":224,"phoneExt":122,"email":225},"Anne Bendel, MD","612-813-5913","Anne.Bendel@childrensmn.org",{"name":223,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":5,"status":146,"city":228,"state":229,"zip":230,"country":150,"countryCode":151,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Memphis","Tennessee","38105",{"type":153,"coordinates":232},[233,234],-90.04898,35.14953,{"lat":234,"lon":233},[237,238,239],{"name":139,"role":140,"phone":141,"phoneExt":122,"email":142},{"name":133,"role":134,"phone":122,"phoneExt":122,"email":122},{"name":136,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":241,"status":146,"city":242,"state":243,"zip":244,"country":150,"countryCode":151,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"UT Southwestern Medical Center\u002FHarold C Simmons Comprehensive Cancer Center","Dallas","Texas","75235",{"type":153,"coordinates":246},[247,248],-96.80667,32.78306,{"lat":248,"lon":247},[251,255],{"name":252,"role":140,"phone":253,"phoneExt":122,"email":254},"Daniel Bowers, MD","214-456-2382","Daniel.Bowers@UTSouthwestern.edu",{"name":252,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":257,"status":146,"city":258,"state":243,"zip":259,"country":150,"countryCode":151,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Cook Children's Medical Center","Fort Worth","76104",{"type":153,"coordinates":261},[262,263],-97.32085,32.72541,{"lat":263,"lon":262},[266,270],{"name":267,"role":140,"phone":268,"phoneExt":122,"email":269},"Sibo Zhao, MD","682-885-4007","sibo.zhao@cookchildrens.org",{"name":267,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":272,"status":146,"city":273,"state":243,"zip":274,"country":150,"countryCode":151,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Texas Children's Hospital","Houston","77477",{"type":153,"coordinates":276},[277,278],-95.36327,29.76328,{"lat":278,"lon":277},[281,285],{"name":282,"role":140,"phone":283,"phoneExt":122,"email":284},"Murali Chintagumpala, MD","832-822-4266","mxchinta@texaschildrens.org",{"name":282,"role":134,"phone":122,"phoneExt":122,"email":122},{"facility":287,"status":146,"city":288,"state":289,"zip":290,"country":150,"countryCode":151,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":153,"coordinates":292},[293,294],-111.89105,40.76078,{"lat":294,"lon":293},[297,301],{"name":298,"role":140,"phone":299,"phoneExt":122,"email":300},"Nicholas Whipple, MD","801-662-4700","nicholas.whipple@hsc.utah.edu",{"name":298,"role":134,"phone":122,"phoneExt":122,"email":122},{"type":303,"investigatorFullName":122,"investigatorTitle":122,"investigatorAffiliation":122,"oldNameTitle":122,"oldOrganization":122},"SPONSOR",[305],{"name":306,"class":307},"National Cancer Institute (NCI)","NIH","100480375","phase-2-molecular-and-clinical-risk-directed-therapy-for-infants-and-young-children-with-newly-diagnosed-medulloblastoma-100480375",false,"NCT05535166","Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma","SJiMB21: Phase 2 Study of Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma","Inclusion Criteria - Screening Phase (All Patients)\n\n* Participants with presumptive\u002Fsuspected newly diagnosed medulloblastoma.\n* Participant meets one of the following criteria at the time of screening:\n\n  * Age \\\u003C 36 months OR Age ≥ 36 months and \\\u003C 60 months with presumptive\u002Fsuspected non-metastatic disease\n* Participant must have adequate tumor tissue from primary tumor for central review of pathology and molecular classification by methylation and IHC\n* Participant must be able to begin treatment as outlined in the protocol within 36 days of definitive surgery (day of surgery is Day 0). In case a second surgery is clinically indicated to remove the residual tumor prior to starting treatment, the second surgery will be considered as the definitive surgery (Day 0).\n* Parent or legal guardian can understand and is willing to sign a written informed consent document according to institutional guidelines.\n\nExclusion Criteria - Screening Phase\n\n* Participants with other clinically significant medical disorders (i.e., serious infections or significant cardiac, pulmonary, hepatic, psychiatric, or other organ dysfunction) that could compromise their ability to tolerate protocol therapy or would interfere with the study procedure.\n\nInclusion Criteria - Study Enrollment (All Patients)\n\n* Participant must be \\\u003C 60 months of age at time of enrollment.\n\n  * Note: Each treatment stratum has additional specific age requirements\n* Participant must have confirmation of newly diagnosed medulloblastoma per Central Review:\n\n  * Central review includes histopathology, IHC and St. Jude Clinical Genomic Methylation Profiling conducted on MLPNet. If tissue or the extracted DNA does not meet quality control criteria for methylation analysis or if methylation classifier is unable assign molecular group\u002Fsubgroup within the assigned classifier (MLPNet) parameters, then IHC will be used to define molecular group of these cases. IHC cannot be used to determine molecular subgroup. Therefore, IHC defined SHH patients will be enrolled on Stratum S-1 under \"SHH-NOS\", and all NWNS and indeterminate molecular group will be enrolled on stratum N.\n  * Note: Diagnosis of medulloblastoma, as well as group and subgroup assignment, will be done by central pathology review at St. Jude only. No outside testing is allowed for trial enrollment.\n* Participant must have disease staged by MRI of the brain and spine and by cytologic examination of CSF\\* and be placed into the following categories:\n\n  * M0: no evidence of metastatic disease.\n\n    * must include a negative CSF cytology result\n  * M1: Tumor cells found in the CSF but no other evidence of metastasis\n  * M2: Intracranial tumor beyond the primary tumor site\n  * M3: Metastatic disease in the spine\n  * M4: Extraneural metastatic disease\n  * \\*All participants are to undergo CSF cytologic examination regardless of presence or absence of gross metastatic disease unless procedure is medically contraindicated. CSF is to be obtained by lumbar puncture (LP) performed at least 10 days after surgery. If LP is medically contraindicated, ventricular CSF from a shunt or Ommaya reservoir may be used for staging but this is not the preferred option due to lower sensitivity. If LP is medically contraindicated and the patient doesn't have a shunt or reservoir for CSF sampling, the treating physician should reach out to PI or Co-PI regarding decision on enrollment to SJiMB21. The decision to enroll without CSF cytology will be made on case-by-case basis.\n  * Note: Participants who have M2 disease and positive CSF will be assigned to M3.\n  * Note: Participants will be assigned to the highest stage number for which they meet eligibility.\n  * Note: Treatment stratums may have additional stage requirements.\n* Patient must have received no previous radiotherapy, chemotherapy, or other brain tumor-directed therapy other than corticosteroid therapy and surgery.\n* Participant must have a Lansky performance score of \\> 30 (except for patients with posterior fossa syndrome.\n* Participant must have adequate organ function prior to study entry, as defined by:\n\n  * Absolute neutrophil counts (ANC) \\>750\u002Fmm\\^3\n  * Platelet count ≥ 50,000\u002Fmm\\^3 without support of a platelet transfusion within 7 days\n  * Hemoglobin ≥8.0 g\u002FdL (with or without support of a blood transfusion).\n  * Normal liver function as defined by Alanine aminotransferase (ALT) concentration ≤ 3 x 45 U\u002FL and total bilirubin ≤ 3 x 1.0.\n* Adequate renal function as defined by a serum creatinine concentration:\n\n  * Age - 0 to \\\u003C1year; Maximum Serum Creatinine (mg\u002Fdl) - Male 0.5; Female 0.5\n  * Age - 1 to \\\u003C 2years; Maximum Serum Creatinine (mg\u002Fdl) - Male 0.6; Female 0.6\n  * Age - 1 to \\\u003C 2yearsr; Maximum Serum Creatinine (mg\u002Fdl) - Male 0.8; Female 0.8\n* Participant's parent or legal guardian has the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.\n\nInclusion Criteria - Stratum S-2\n\n* Participant must have confirmed diagnosis of the following medulloblastoma molecular group and subgroup per Central Review.\n\n  * Medulloblastoma SHH-2\n* Participant must meet one of the following criteria at time of enrollment:\n\n  * Age \\\u003C36 months OR Age ≥ 36 months and \\\u003C 60 months with non-metastatic disease (M0) Inclusion Criteria - Stratum S-1\n* Participant must have confirmed diagnosis of one of the following medulloblastoma molecular subgroups per Central Review.\n\n  * Medulloblastoma SHH-1\n  * Medulloblastoma SHH-3\n  * Medulloblastoma SHH-4\n  * Medulloblastoma SHH-NOS\n\n    * Includes medulloblastoma cases that could not be assigned to a molecular subgroup using the DNA methylation classifier, but which are in the SHH group and\u002For cases defined as SHH by IHC.\n* Participant must be \\\u003C 36 months of age at time of enrollment\n\n  * Note: Patients who are \\\u003C 36 months of age, regardless of metastatic status (M0\u002FM+), are eligible for enrollment on stratum S-1.\n\nInclusion Criteria - Stratum N\n\n* Participant must have confirmed diagnosis of one of the following medulloblastoma molecular subgroups per Central Review.\n\n  * Medulloblastoma G3\n  * Medulloblastoma G4\n  * Medulloblastoma - Not classified into SHH (i.e., NWNS or indeterminate)\n\n    * Includes medulloblastoma cases that could not be assigned to a molecular group using the DNA methylation classifier but which are in the NWNS class and\u002For defined as NWNS by IHC.\n* Participant must be \\\u003C36 months of age at time of enrollment\n* All NWNS patients (M+ and M0) are eligible for enrollment in stratum N\n\nExclusion Criteria - All Patients\n\n* CNS embryonal tumor other than medulloblastoma, for example, patients with diagnosis of Atypical Teratoid\u002FRhabdoid Tumor (ATRT), PNET, Pineoblastoma, Ependymoma, and ETMR are excluded.\n* Participant with prior treatment for medulloblastoma, including:\n\n  * Radiotherapy\n  * Chemotherapy\n  * Cancer directed immunotherapy\n  * Targeted agents\n  * NOTE: Corticosteroid therapy is acceptable; prior treatment with chemotherapy, immunotherapy or targeted agents for non-cancer directed indications are acceptable as long as these have been stopped at least 14 days prior to start of therapy or 2 half-lives from last dose. (i.e., methotrexate for juvenile rheumatoid arthritis, JAK inhibitor therapy for eczema, etc.)\n* Participant who is actively receiving any other investigational agents.\n* Participant with other clinically significant medical disorders (i.e., serious infections or significant cardiac, pulmonary, hepatic, psychiatric, or other organ dysfunction) that could compromise their ability to tolerate protocol therapy or would interfere with the study procedures or results.","ALL","59 Months",{"count":318,"type":319},130,"ESTIMATED","INTERVENTIONAL",[322],"PHASE2","This is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.",[325],"Medulloblastoma",[327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344],"SJiMB21","Brain Cancer","Brain Tumors in Children","Medulloblastoma Sonic Hedgehog subgroup 1","Medulloblastoma Sonic Hedgehog subgroup 2","Medulloblastoma Sonic Hedgehog subgroup 3","Medulloblastoma Sonic Hedgehog subgroup 4","Medulloblastoma Sonic Hedgehog-not otherwise specified","Medulloblastoma G3","Medulloblastoma G4","Medulloblastoma indeterminate","MLPNet","Neural Net Classification Pipeline","Non-WNT non-SHH medulloblastoma","Posterior fossa syndrome","St. Jude Brain Tumor Studies","Treatment for Brain Tumors in Infants and Young Children","Untreated Childhood Medulloblastoma","2026-02-10",{"date":347,"type":348},"2026-02-12","ACTUAL",{"date":350,"type":348},"2022-12-20",{"date":352,"type":319},"2035-07",{"name":5,"class":6},10]