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Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site contacts updated at 1 of 12 sitesv6
  2. Minor Site details revised at 5 of 12 sitesv5
  3. Minor Study sites: 6 to 12v4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 6
    • Primary completion date: Sep 2030 to Dec 31, 2030
    • Study completion date: Sep 2032 to Dec 31, 2032
    • Start date changed from estimate of Sep 2025 to Sep 23, 2025
  5. Notable Start date: Jun 2025 to Sep 2025
    • Primary completion date: Jun 2030 to Sep 2030
    • Study completion date: Jun 2032 to Sep 2032
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,251 trials monitored
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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.
Trial Details
NCT Number NCT06942039
Lead Sponsor C17 Council
Conditions
(from sponsor)
CNS Embryonal Tumor, CNS, Medulloblastoma, Atypical Teratoid Rhabdoid Tumor, Medulloblastoma, Childhood, Medulloblastoma, Group 3, Medulloblastoma, Group 4, Pineoblastoma, Neuroblastoma +6 more
Related terms Medulloblastoma, Neuroblastoma, Neuroectodermal Tumors, Primitive, Pinealoma, Pyloric Stenosis, Hypertrophic, Rhabdoid Tumor
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov