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Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors

StatusRecruiting
PhasePhase 1/2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 24 wordsv17
  2. Primary completion date: Nov 2027 to Nov 2028
    • Study completion date: Nov 2027 to Nov 2033
    v16
  3. Eligibility criteria shortened, about 3 words
    • Study description expanded, about 4 words
    v15
  4. Site details revised at 1 of 4 sitesv14
  5. Eligibility criteria shortened, about 85 words
    • Site contacts updated at 1 of 4 sites
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Publications revised (47)v12
  2. Primary endpoints revised (4)
    • Eligibility criteria revised
    • Secondary endpoints revised (2)
    • Study description expanded, about 4 words
    v11
  3. Primary completion date: Nov 2025 to Nov 2027v10
  4. Study sites: 9 to 4v9
  5. Lead sponsor: Ralph NULL Salloum to Nationwide Children's Hospital
    • Collaborators shortened, about 5 words
    v8
  6. Lead sponsor: Ralph Salloum to Ralph NULL Salloumv7 Show 5 more changesShow less
    • Eligibility criteria shortened, about 173 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 2 of 9 sites
    • Study description shortened, about 5 words
    • Study title shortened, about 4 words
  7. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Dec 20, 2024 to Nov 2025
    • Study completion date: Dec 20, 2026 to Nov 2027
    • Start date changed from estimate of Dec 20, 2022 to Nov 21, 2022
    • Site details revised at 9 of 9 sites
  8. Start date: Sep 25, 2022 to Dec 20, 2022
    • Primary completion date: Sep 25, 2024 to Dec 20, 2024
    • Study completion date: Sep 25, 2026 to Dec 20, 2026
    v5
  9. Start date: Aug 25, 2022 to Sep 25, 2022
    • Primary completion date: Aug 25, 2024 to Sep 25, 2024
    • Study completion date: Aug 25, 2026 to Sep 25, 2026
    v4
  10. Start date: May 25, 2022 to Aug 25, 2022
    • Primary completion date: May 25, 2024 to Aug 25, 2024
    • Study completion date: May 25, 2026 to Aug 25, 2026
    v3
  11. Start date: Mar 15, 2022 to May 25, 2022
    • Primary completion date: Mar 15, 2024 to May 25, 2024
    • Study completion date: Mar 15, 2026 to May 25, 2026
    v2
  1. 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.
This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)
Trial Details
NCT Number NCT05278208
Lead Sponsor Nationwide Children's Hospital
Conditions
(from sponsor)		 High Grade Glioma, Meningioma, Embryonal Tumor, Medulloblastoma, Anaplastic Ependymoma, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma +5 more
Related terms Central Nervous System Neoplasms, Diffuse Intrinsic Pontine Glioma, Ependymoma, Glioma, Medulloblastoma, Meningioma, Neoplasms, Germ Cell and Embryonal
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov