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Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma

StatusRecruiting
PhasePhase 2
Started2022-12-20
View on ClinicalTrials.gov ↗

Amendment history

2026-02-10
minor
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v20
Enrollment target120→130
InterventionsCarboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Educational and Media Intervention (Other), Etoposide (Drug), Filgrastim…→Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Educational and Media Intervention (Other), Etoposide (Drug), Filgrastim…
Secondary endpointsdetails revised at 2 of 23 entries
Study description+144 characters
[...] se A (A1A2A3A4) 2 Course B (B1B2) 2 Course C (C1C2) Courses repeatsrepeat every 28 days/4 weeks. Stratum S-1: Patients on S-1 will re [...] se A with IVT, 2 Course B with IVT and 2 Course C). Courses repeatsrepeat every 28 days/4 weeks. Stratum N: Stratum N participants wi [...] : 4 cycles (A1A2A3A4) Age: ≥30 to <32 months-old: 6 cycles (A1A2A3A4B1B2A1A2A3A4 B1B2) Age: ≥28 to <30-months-old: 8 cycles (A1A2A3A4B1B2C1C2A1A2A3A4 B1B2 C1C2) Age: < 28 months-old: 8 cycles + multiple cycles of Course D until 36 months old (A1A2A3A4 B1B2 C1C2D1D2D3D4C1C2 D1D2D3D4…) Courses A, B, C and E repeatsrepeat every 28 days [...] [...]
Study sites10 entries, revised
Lucille Packard Children's Hospital at Stanford University UT Southwestern Medical Center/Harold C Simmons Comprehensive Cancer Center
2026-01-15
minor
Study Status, Contacts/Locations v19
Re-verified, no change to tracked fields
2025-04-22
minor
Study Status, Study Description v18
Study description+51 characters
[...] nfants undergoing treatment for medulloblastoma. (funded by anNCI R21via the R21CA280187) To estimate the magnitude of change in parent-child intera [...] aired with interactive neurodevelopmental games. (funded by anNCI R21via the R21CA280187) To estimate the magnitude of change in cognition and socia [...] bined with interactive neurodevelopmental games. (funded by anNCI R21via the R21CA280187) To determine the extent of inter- and intra-patient variab [...]
2025-04-16
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description v17
Study description+57 characters
[...] ioning in infants undergoing treatment for medulloblastoma. (funded by an R21) To estimate the magnitude of change in parent-child interact [...] education paired with interactive neurodevelopmental games. (funded by an R21) To estimate the magnitude of change in cognition and social- [...] program combined with interactive neurodevelopmental games. (funded by an R21) To determine the extent of inter- and intra-patient variabil [...]
Collaborators+31 characters
National Cancer Institute (NCI)
2025-04-07
minor
Study Status v16
Re-verified, no change to tracked fields
Show 15 earlier versions
2024-10-28
minor
Study Status, Contacts/Locations v15
Study sites9→10
2024-09-17
minor
Study Status, Contacts/Locations v14
Study sites7→9
2024-07-09
minor
Study Status, Contacts/Locations v13
Study sites6→7
2024-04-12
minor
Study Status, Contacts/Locations v12
Study sites5→6
2024-02-27
minor
Study Status, Contacts/Locations v11
Study sites4→5
2023-11-07
minor
Study Status, Contacts/Locations v10
Study sites3→4
2023-10-27
minor
Study Status, Contacts/Locations v9
Study sites2→3
2023-09-19
minor
Study Status, Contacts/Locations v8
Study sites1→2
2023-05-11
minor
Study Status, Arms and Interventions, Outcome Measures, Eligibility v7
Study arms3→5
InterventionsCarboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Etoposide (Drug), Filgrastim (Drug), Irradiation (Radiation), Methotrexate…→Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Educational and Media Intervention (Other), Etoposide (Drug), Filgrastim…
Eligibility criteria-201 characters
[...] tients (M+ and M0) are eligible for enrollment in stratum N Inclusion Criteria - Stratum P Biological parent(s) of participant (child) enrolling on SJiMB21. These parents will be assigned to Stratum P. The exclusion criteria below do not apply to this stratum. Exclusion Criteria - All Patients CNS embryonal tumor other [...]
Secondary endpointsdetails revised at 1 of 23 entries
2023-01-11
minor
Study Status v6
Start dateestimated 2023-01→confirmed 2022-12-20
2022-12-19
minor
Study Status v5
Start date2022-12→2023-01
2022-11-30
minor
Study Status v4
Start date2022-11→2022-12
2022-10-28
minor
Study Status v3
Start date2022-10→2022-11
2022-09-30
minor
Study Status v2
Start date2022-09→2022-10
2022-09-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2022-09-07
minor
Original filing
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.
Trial Details
NCT Number NCT05535166
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: National Cancer Institute (NCI)
Conditions Medulloblastoma
Enrollment 130 participants
Start Date 2022-12-20
Primary Completion 2035-07 (estimated)
Study Completion 2035-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-15