Actively Recruiting
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Led by Mayo Clinic · Updated on 2026-04-22
42
Participants Needed
1
Research Sites
620 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous treatment for meningioma including surgery if possible, and radiation therapy
- Radiographic evidence of meningioma progression with measurable disease showing 15% or more growth in about 6 months or new measurable lesion
- Prior fractionated radiation therapy or stereotactic radiosurgery at the site of progression with no safe option for further radiotherapy
- Willingness to undergo 68Ga-DOTATATE PET imaging with a Krenning score of 2 or higher
- Measurable disease present
- ECOG performance status of 0, 1, or 2
- Absolute neutrophil count of 1500/mm or higher within 28 days prior to registration
- Platelet count of 100,000/mm or higher within 28 days prior to registration
- Hemoglobin level of 9.0 g/dL or higher within 28 days prior to registration
- Direct bilirubin less than 1.5 times the upper limit of normal (ULN), or total bilirubin up to 3.0 times ULN with direct bilirubin less than 1.5 times ULN for Gilbert's syndrome patients within 28 days prior to registration
- Aspartate transaminase (AST) level less than or equal to 3 times ULN within 28 days prior to registration
- Prothrombin time (PT), INR, or PTT less than or equal to 1.5 times ULN or within therapeutic range if on anticoagulants within 28 days prior to registration
- Creatinine clearance of 40 ml/min or higher using Cockcroft-Gault formula within 28 days prior to registration
- Ability to complete questionnaires independently or with assistance
- Provide written informed consent
- Willingness to return to the enrolling institution for follow-up visits
- Willingness to undergo SPECT/CT imaging for dosimetry analysis until 21 slots are filled
You will not qualify if you...
- Eligible for surgery or radiation treatment aimed at cure
- Pregnant women, nursing women, or men and women of childbearing potential unwilling to use adequate contraception
- Presence of severe systemic illnesses or other serious diseases that interfere with safety assessment
- Contraindications to or intolerance of MRI
- Immunocompromised patients or those with HIV infection currently on antiretroviral therapy
- Uncontrolled illnesses including infection, symptomatic heart failure (NYHA II-IV), unstable angina, uncontrolled diabetes, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Receiving other investigational treatments for the primary tumor, including somatostatin LAR within 4 weeks or short-acting octreotide that cannot be paused for over 24 hours before treatment
- Other active cancers within 2 years except non-melanotic skin cancer or in-situ cervical cancer, unless not receiving treatment
- History of myocardial infarction within 6 months or congestive heart failure requiring ongoing therapy for life-threatening arrhythmias
- Current spontaneous urinary incontinence preventing safe administration of LUTATHERA
- Untreated or symptomatic toxicity from prior radiation including necrosis or radiation-related eye conditions
- Optic nerve sheath meningioma or extracranial meningioma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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