drugset / Trial / NCT05278208
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
NaSingle-groupOpen-labelTreatment
Summary
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)
Timeline
- Start
- 2022-11-21
- Primary completion
- 2028-11
- Completion
- 2033-11
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-DOTATATE | Peptide | 150 unknown | Intravenous |
| Subject | 177Lu-DOTATATE | Peptide | 200 unknown | Intravenous |
| Subject | 177Lu-DOTATATE | Peptide | 250 unknown | Intravenous |