OncoMatch/Clinical Trials/NCT04997317
Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide
Is NCT04997317 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over) and 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4 for meningioma.
Treatment: 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over) · 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4 · 177Lu-DOTA-JR11 (Phase I/II) — Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: therapeutic radio-pharmaceutical
Prior or planned administration of a therapeutic radio-pharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
Cannot have received: extensive radiotherapy involving bone marrow
Any extensive Radiotherapy involving bone marrow over the last 3 months before inclusion to the study
Cannot have received: chemotherapy
Chemotherapy in the last 2 months before inclusion
Lab requirements
Blood counts
Leucocytes ≥ 3*10^9/L; Haemoglobin ≥ 80 g/L; Thrombocytes ≥ 90*10^9/L; Albumin > 25g/L
Kidney function
Estimated glomerular filtration rate ≥ 50 ml/min
Liver function
alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤ 5 times upper standard value; Bilirubin ≤ 2 times upper standard value
Blood parameter criteria: Leucocytes ≥ 3*10^9/L; Haemoglobin ≥ 80 g/L; Thrombocytes ≥ 90*10^9/L; Estimated glomerular filtration rate ≥ 50 ml/min; Albumin > 25g/L; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤ 5 times upper standard value; Bilirubin ≤ 2 times upper standard value
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