[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588487":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":114,"centralContacts":125,"locations":133,"responsibleParty":310,"collaborators":35,"id":312,"slug":35,"hasResults":313,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":35,"eligibilityCriteria":317,"healthyVolunteers":313,"sex":318,"minAge":35,"maxAge":319,"enrollmentInfo":320,"targetDuration":35,"studyType":323,"phases":324,"briefSummary":326,"conditions":327,"keywords":342,"overallStatus":135,"whyStopped":35,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},{"fullName":5,"class":6},"C17 Council","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Comprehensive Multimodal Therapy Including Induction, Consolidation, and Risk-Adapted Maintenance","EXPERIMENTAL","Participants will undergo a comprehensive treatment regimen beginning with three 21-day cycles of Induction chemotherapy including intrathecal (IT) cytarabine with hydrocortisone, cyclophosphamide, etoposide, vinCRIStine, and cisplatin. Peripheral blood stem cells will be collected during this phase for later use. Patients who achieve complete response (CR) proceed directly to Consolidation; those who do not may undergo second-look surgery or national tumor board review.\n\nConsolidation consists of three 28-day cycles of CARBOplatin and thiotepa followed by autologous stem cell rescue. Patients then proceed to up to 48-54 weeks of Maintenance chemotherapy based on risk stratification.\n\nLow-risk patients receive monthly IT topotecan and a 28-day metronomic regimen including tamoxifen and ISOtretinoin.\n\nHigh-risk patients receive monthly IT topotecan and a more intensive regimen every 9 weeks including ISOtretinoin, celecoxib, etoposide, cyclophosphamide, and temozolomide.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28],"Drug: Cytarabine IT","Drug: hydrocortisone","Drug: Cisplatin","Drug: Vincristine","Drug: Etoposide","Drug: Cyclophosphamide","Drug: Mesna","Drug: Filgrastim","Drug: carboplatin","Drug: Thiotepa","Drug: Topotecan IT","Drug: Tamoxifen","Drug: ISOtretinoin","Drug: Celecoxib","Drug: etoposide phosphate","Drug: Temozolomide",[30,36,40,46,52,56,62,66,72,78,84,90,94,98,102,108],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Cytarabine IT","Age-based dosing as a part of double IT therapy (cytarabine, hydrocortisone) during induction (3 cycles, 1 cycle = 21 days) alongside CISplatin, vinCRIStine, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).",[9],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"hydrocortisone","Double IT therapy (cytarabine, hydrocortisone) during induction (3 cycles, 1 cycle = 21 days) alongside CISplatin, vinCRIStine, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).",[9],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Cisplatin","Intravenous CISplatin given on Day 1 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, vinCRIStine, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).",[9],[45],"CDDP",{"type":31,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Vincristine","Intravenous VinCRIStine given on Days 1, 8 \\& 15 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, CISplatin, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).",[9],[51],"VCR",{"type":31,"name":53,"description":54,"armGroupLabels":55,"otherNames":35},"Etoposide","Induction: Intravenous Etoposide given on Days 1, 2 \\& 3 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, CISplatin, vinCRIStine, cyclophosphamide, mesna and filgrastim (G-CSF).\n\nMaintenance Arm B (for high-risk patients): Oral Etoposide given on Days 1-21 every 9 weeks (max 6 cycles, 1 cycle = 9 weeks) in combination with IT Topotecan, ISOtretinoin, Celecoxib, Cyclophosphamide and Temozolomide.",[9],{"type":31,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Cyclophosphamide","Induction: Intravenous high-dose Cyclophosphamide given on Days 2 \\& 3 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, CISplatin, vinCRIStine, etoposide, mesna and filgrastim (G-CSF).\n\nMaintenance Arm B (for high-risk patients): Oral Cyclophosphamide given on Days 1-21 every 9 weeks (max 6 cycles, 1 cycle = 9 weeks) in combination with IT Topotecan, ISOtretinoin, Celecoxib, Etoposide and Temozolomide.",[9],[61],"CPM",{"type":31,"name":63,"description":64,"armGroupLabels":65,"otherNames":35},"Mesna","Induction: Intravenous Mesna given at hour 0 of Cyclophosphamide delivery and 3, 6, 9 \\& 12 hours post-dose during induction (3 cycles, 1 cycle = 21 days).",[9],{"type":31,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Filgrastim","Induction: Subcutaneous or intravenous Filgrastim (G-CSF) given 24-48 hrs after last dose of chemotherapy and\u002For as per institutional guidelines until count recovery.\n\nConsolidation: Subcutaneous or intravenous Filgrastim (G-CSF) given 24-48 hours after last stem cell infusion and\u002For per institutional guidelienes until count recovery.",[9],[71],"G-CSF",{"type":31,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"carboplatin","Consolidation: Intravenous Carboplatin given on days -3 \\& -2 during consolidation alongside thiotepa and filgrastim.",[9],[77],"CARBO",{"type":31,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Thiotepa","Consolidation: Intravenous Thiotepa given on days -3 \\& -2 during consolidation alongside carboplatin and filgrastim.",[9],[83],"THIO",{"type":31,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Topotecan IT","Maintenance A (for low-risk patients): IT Topotecan on Day 1 of each cycle (max 12 cycles, 1 cycle = 28 days) alongside Tamoxifen and ISOtretinoin.\n\nMaintenance B (for high-risk patients): IT Topotecan every 4 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside ISOtretinoin, Celecoxib, Etoposide, Cyclophosphamide and Temozolomide.",[9],[89],"Intrathecal Topotecan",{"type":31,"name":91,"description":92,"armGroupLabels":93,"otherNames":35},"Tamoxifen","Maintenance A (for low-risk patients): Oral Tamoxifen twice daily, Days 1-28 (max 12 cycles, 1 cycle = 28 days) alongside ISOtretinoin and IT Topotecan.",[9],{"type":31,"name":95,"description":96,"armGroupLabels":97,"otherNames":35},"ISOtretinoin","Maintenance A (for low-risk patients): Oral ISOtretinoin twice daily on Days 15-28 of each cycle (max 12 cycles, 1 cycle = 28 days) alongside Tamoxifen and IT Topotecan.\n\nMaintenance B (for high-risk patients): Oral ISOtretinoin twice daily on Days 1-21, every 6 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside IT Topotecan, Celecoxib, Etoposide, Cyclophosphamide and Temozolomide.",[9],{"type":31,"name":99,"description":100,"armGroupLabels":101,"otherNames":35},"Celecoxib","Maintenance B (for high-risk patients): Oral Celecoxib twice daily on Days 1-21, every 6 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside IT Topotecan, ISOtretinoin, Etoposide, Cyclophosphamide and Temozolomide.",[9],{"type":31,"name":103,"description":104,"armGroupLabels":105,"otherNames":106},"etoposide phosphate","During Induction and Maintenance B (for high-risk patients), etoposide phosphate may be given for subsequent doses to patients who have experienced etoposide allergic reactions.",[9],[107],"Etopophos",{"type":31,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"Temozolomide","Maintenance B (for high-risk patients): Oral Temozolomide daily on Days 1-21, every 9 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside IT Topotecan, ISOtretinoin, Etoposide, Cyclophosphamide and Celecoxib.",[9],[113],"TMZ",[115,119,122],{"name":116,"affiliation":117,"role":118},"Sylvia Cheng","BC Cancer Centre","STUDY_CHAIR",{"name":120,"affiliation":121,"role":118},"Annie Huang","The Hospital for Sick Children",{"name":123,"affiliation":124,"role":118},"Lucie Lafay-Cousin","Alberta Children's Hospital",[126,131],{"name":116,"role":127,"phone":128,"phoneExt":129,"email":130},"CONTACT","416-813-7654","414839","sylvia.cheng@cw.bc.ca",{"name":5,"role":127,"phone":35,"phoneExt":35,"email":132},"DECRYPT-BABYBRAIN@C17.ca",[134,154,169,184,200,215,229,244,255,269,283,297],{"facility":124,"status":135,"city":136,"state":137,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"RECRUITING","Calgary","Alberta","Canada","CA",{"type":141,"coordinates":142},"Point",[143,144],-114.08529,51.05011,{"lat":144,"lon":143},[147,150,152],{"name":148,"role":127,"phone":35,"phoneExt":35,"email":149},"Oluwatosin Ogunleye","Oluwatosin.Ogunleye@albertahealthservices.ca",{"name":123,"role":127,"phone":35,"phoneExt":35,"email":151},"lucie.lafay-cousin@albertahealthservices.ca",{"name":123,"role":153,"phone":35,"phoneExt":35,"email":35},"PRINCIPAL_INVESTIGATOR",{"facility":155,"status":135,"city":156,"state":157,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"BC Children's Hospital","Vancouver","British Columbia",{"type":141,"coordinates":159},[160,161],-123.11934,49.24966,{"lat":161,"lon":160},[164,167],{"name":165,"role":127,"phone":35,"phoneExt":35,"email":166},"Sofie Jensen","sofie.jensen@cw.bc.ca",{"name":168,"role":153,"phone":35,"phoneExt":35,"email":35},"George Michaiel",{"facility":170,"status":135,"city":171,"state":172,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"CancerCare Manitoba (CCMB)","Winnipeg","Manitoba",{"type":141,"coordinates":174},[175,176],-97.14704,49.8844,{"lat":176,"lon":175},[179,182],{"name":180,"role":127,"phone":35,"phoneExt":35,"email":181},"Megan Ridler","mridler@cancercare.mb.ca",{"name":183,"role":153,"phone":35,"phoneExt":35,"email":35},"Divya Subburaj",{"facility":185,"status":186,"city":187,"state":188,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"IWK Health Centre","NOT_YET_RECRUITING","Halifax","Nova Scotia",{"type":141,"coordinates":190},[191,192],-63.57688,44.64269,{"lat":192,"lon":191},[195,198],{"name":196,"role":127,"phone":35,"phoneExt":35,"email":197},"Tiffany Rent","Tiffany.Rent@iwk.nshealth.ca",{"name":199,"role":153,"phone":35,"phoneExt":35,"email":35},"Bruce Crooks",{"facility":201,"status":135,"city":202,"state":203,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"McMaster Children's Hospital","Hamilton","Ontario",{"type":141,"coordinates":205},[206,207],-79.84963,43.25011,{"lat":207,"lon":206},[210,213],{"name":211,"role":127,"phone":35,"phoneExt":35,"email":212},"Shawde Campbell","campshaw@HHSC.CA",{"name":214,"role":153,"phone":35,"phoneExt":35,"email":35},"Adam Fleming",{"facility":216,"status":135,"city":217,"state":203,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"London Health Sciences Centre","London",{"type":141,"coordinates":219},[220,221],-81.23304,42.98339,{"lat":221,"lon":220},[224,227],{"name":225,"role":127,"phone":35,"phoneExt":35,"email":226},"Jessica Kuzyk","jessica.kuzyk@lhsc.on.ca",{"name":228,"role":153,"phone":35,"phoneExt":35,"email":35},"Shayna Zelcer",{"facility":230,"status":135,"city":231,"state":232,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"CHU Sainte-Justine","Montreal","Quebec",{"type":141,"coordinates":234},[235,236],-73.58781,45.50884,{"lat":236,"lon":235},[239,242],{"name":240,"role":127,"phone":35,"phoneExt":35,"email":241},"Caroline Tra","caroline.tra.hsj@ssss.gouv.qc.ca",{"name":243,"role":153,"phone":35,"phoneExt":35,"email":35},"Sebastien Perreault",{"facility":245,"status":186,"city":231,"state":232,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":246,"geoPoint":248,"contacts":249},"Montreal Children's Hospital (McGill)",{"type":141,"coordinates":247},[235,236],{"lat":236,"lon":235},[250,253],{"name":251,"role":127,"phone":35,"phoneExt":35,"email":252},"Poshia Boateng","poshia.boateng@muhc.mcgill.ca",{"name":254,"role":153,"phone":35,"phoneExt":35,"email":35},"Christina Coleman",{"facility":256,"status":135,"city":257,"state":232,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"CHU de Québec-Université Laval","Québec",{"type":141,"coordinates":259},[260,261],-71.21454,46.81228,{"lat":261,"lon":260},[264,267],{"name":265,"role":127,"phone":35,"phoneExt":35,"email":266},"Panagiota Giannakouros","Panagiota.Giannak@crchudequebec.ulaval.ca",{"name":268,"role":153,"phone":35,"phoneExt":35,"email":35},"Samuele Renzi",{"facility":270,"status":135,"city":271,"state":232,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Centre hospitalier universitaire de Sherbrooke (CHUS)","Sherbrooke",{"type":141,"coordinates":273},[274,275],-71.89908,45.40008,{"lat":275,"lon":274},[278,281],{"name":279,"role":127,"phone":35,"phoneExt":35,"email":280},"Alexis Gonneaud","alexis.gonneaud.ciussse-chus@ssss.gouv.qc.ca",{"name":282,"role":153,"phone":35,"phoneExt":35,"email":35},"Stephanie Vairy",{"facility":284,"status":135,"city":285,"state":35,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Stollery Children's Hospital","Edmonton",{"type":141,"coordinates":287},[288,289],-113.46871,53.55014,{"lat":289,"lon":288},[292,295],{"name":293,"role":127,"phone":35,"phoneExt":35,"email":294},"Guru Piragasam","Guru.Piragasam@albertahealthservices.ca",{"name":296,"role":153,"phone":35,"phoneExt":35,"email":35},"Liana Nobre",{"facility":121,"status":135,"city":298,"state":35,"zip":35,"country":138,"countryCode":139,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Toronto",{"type":141,"coordinates":300},[301,302],-79.39864,43.70643,{"lat":302,"lon":301},[305,308],{"name":306,"role":127,"phone":35,"phoneExt":35,"email":307},"Grace Silver","grace.silver@sickkids.ca",{"name":309,"role":153,"phone":35,"phoneExt":35,"email":35},"Anthony Liu",{"type":311,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100588487",false,"NCT06942039","Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children \u003C 6 Years, Post Consolidation","A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age","Inclusion Criteria:\n\n1. Tumor Tissue Sample\n2. Age: Patient must be aged ≥ 0 years to ≤ 6 years at the time of definitive confirmation of histologic diagnosis of eligible CNS tumor.\n3. Diagnoses. Participants must have Central nervous system (CNS) HR-EBT including atypical teratoid rhabdoid tumour (ATRT), group 3 and group 4 medulloblastoma (MB), pineoblastoma, CNS neuroblastoma, embryonal tumor with multi-layered rosettes (ETMR including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI-1 intact) and CNS embryonal tumor, not otherwise specified. Metastatic disease included. Any extent of resection included.\n4. Cranial and Spine MRI. A baseline MRI brain and spine with and without contrast is required for all patients. cranial MRI (with and without gadolinium) must be done pre-operatively. Post-operatively, cranial MRI (with and without gadolinium) must be done.\n5. Lumbar Puncture (LP) CSF for cytopathology (strongly recommended but not mandatory; if medically feasible). A baseline LP CSF cytology either pre-operatively or post-operatively at least 10 days after definitive surgery for all patients if medically feasible (This is not mandatory and will not make the patient ineligible).\n6. Life expectancy: Patients must have a life expectancy of greater than 8 weeks from diagnosis.\n7. Performance level: Patients must have a performance status corresponding of a Lansky score ≥ 50.\n8. Organ Function Requirements: Participants must have normal organ and marrow function as defined below:\n\nAdequate renal function defined as:\n\n\\- Creatinine clearance (12-24-hour urine collection) or radioisotope glomerular filtration rate (GFR) ≥ 60 ml\u002Fmin\u002F1.73m2\n\nAdequate cardiac function defined as:\n\n* Shortening fraction of ≥ 27% by echocardiogram, or\n* Ejection fraction of ≥ 47% by radionuclide angiogram.\n\nAdequate pulmonary function defined as:\n\n\\- No evidence of dyspnea at rest and a pulse oximetry \\> 94% on room air.\n\nAdequate Bone Marrow Function defined as:\n\n* Peripheral absolute neutrophil count (ANC) \\> 1000\u002FμL\n* Platelet Count \\> 100,000\u002FμL (without transfusion for 3 days)\n* Hemoglobin greater than 8 gm\u002FdL (may have received red blood cell (RBC) transfusions)\n\nAdequate liver function defined as:\n\n* Total bilirubin ≤ 1.5X upper limit of normal (ULN) within normal institutional limits for age (patients with documented Gilbert's Disease may be enrolled with Study Chair approval and total bilirubin ≤ 2.0 × ULN)\n* Alanine Aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 100 U\u002FL\n\nExclusion criteria:\n\n1. Patients who are receiving any other conventional anti-cancer agents or investigational agents.\n2. Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids.\n3. Presence of another malignancy, except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.\n4. Concomitant medications restrictions: Concurrent use of enzyme inducing anticonvulsants (e.g. phenytoin, phenobarbital, and carbamazepine), selected strong inhibitors of cytochrome P450 3A4 include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort or CYP450 3A4 stimulators or inhibitors.\n5. Other uncontrollable medical disease: Patient has a severe and uncontrollable medical disease (i.e., uncontrolled diabetes, hyperglycemia, chronic renal disease or active uncontrolled infection), has chronic liver disease (i.e., chronic active hepatitis and cirrhosis), hypercholesterolemia (serum cholesterol \\>300 mg\u002FdL), intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active hyperparathyroidism, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n6. Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or C.\n7. Ineligible diagnoses for study entry by neuropathology: This includes sonic hedgehog (SHH) and wingless (WNT) MBs, all ependymomas, all choroid plexus carcinomas, all high grade glial and glio-neuronal tumors, all diffuse midline gliomas, all primary CNS germ cell tumors, all primary CNS sarcomas, all primary or metastatic CNS lymphomas and solid leukemic lesions (chloromas, granulocytic sarcomas).\n8. The participant or parent(s)\u002Fguardian(s) cannot comply with the study visit schedule and other protocol requirements, in the investigator's opinion.\n\nAll patients must meet inclusion\u002Fexclusion criteria prior to starting any protocol therapy.","ALL","6 Years",{"count":321,"type":322},15,"ESTIMATED","INTERVENTIONAL",[325],"EARLY_PHASE1","Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.",[328,329,330,331,332,333,334,335,336,337,338,339,340,341],"CNS Embryonal Tumor","CNS, Medulloblastoma","Atypical Teratoid Rhabdoid Tumor","Medulloblastoma, Childhood","Medulloblastoma, Group 3","Medulloblastoma, Group 4","Pineoblastoma","Neuroblastoma","Embryonal Tumor With Multilayered Rosettes","Embryonal Tumor With Abundant Neuropil and True Rosettes","Ependymoblastoma","Medulloepithelioma","CNS Embryonal Tumor With Rhabdoid Features","CNS Embryonal Tumor, Nos",[343],"HR-EBT","2026-06-05",{"date":346,"type":347},"2026-06-08","ACTUAL",{"date":349,"type":347},"2025-09-23",{"date":351,"type":322},"2032-12-31",{"name":5,"class":6},12]