OncoMatch/Clinical Trials/NCT04082520
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Is NCT04082520 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lutetium Lu 177 Dotatate for grade 1 meningioma.
Treatment: Lutetium Lu 177 Dotatate — This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill tumor cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment. WHO Grade I and Cohort WHO II/III cohorts will be evaluated.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgery — when possible
Previous treatment for meningioma including surgery, when possible, and radiation therapy (conventional fractionated or radiosurgery)
Must have received: radiation therapy — conventional fractionated or radiosurgery
Previous treatment for meningioma including surgery, when possible, and radiation therapy (conventional fractionated or radiosurgery)
Must have received: radiation therapy — fractionated or stereotactic radiosurgery at the site of progressive meningioma
Previous treatment with either fractionated radiation therapy or stereotactic radiosurgery at the site of progressive meningioma, without safe option for further radiotherapy
Cannot have received: somatostatin LAR
Exception: within 4 weeks prior to enrollment
treatment with somatostatin LAR within 4 weeks prior to enrollment
Cannot have received: short-acting octreotide
Exception: cannot be interrupted for greater than 24 hours before treatment
any patient receiving treatment with short-acting octreotide that cannot be interrupted for greater than 24 hours before treatment
Lab requirements
Blood counts
ANC >= 1500/mm; Platelet count >= 100,000/mm; Hemoglobin >= 9.0 g/dL
Kidney function
Calculated creatinine clearance >= 40 ml/min using the Cockcroft-Gault formula (CDK-EPI equation)
Liver function
Direct bilirubin < 1.5 x ULN (or total bilirubin <= 3.0 x ULN with direct bilirubin <= 1.5 x ULN in patients with well-documented Gilbert's syndrome); AST <= 3 x ULN
ANC >= 1500/mm (obtained <= 28 days prior to registration); Platelet count >= 100,000/mm (obtained <= 28 days prior to registration); Hemoglobin >= 9.0 g/dL (obtained <= 28 days prior to registration); Direct bilirubin < 1.5 x ULN (or total bilirubin <= 3.0 x ULN with direct bilirubin <= 1.5 x ULN in patients with well-documented Gilbert's syndrome) (obtained <= 28 days prior to registration); AST <= 3 x ULN (obtained <= 28 days prior to registration); Calculated creatinine clearance >= 40 ml/min using the Cockcroft-Gault formula (obtained <= 28 days prior to registration) using the Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI) equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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