Lutathera for Inoperable, Progressive Meningioma
This study is testing a drug called Lutetium Lu 177 Dotatate (Lutathera) for people with meningioma that cannot be removed by surgery and has continued to grow or spread after radiation therapy. Lutathera is given through a vein and is designed to target and kill tumor cells. The study aims to see if Lutathera is safe and effective in treating these meningiomas. Researchers will look at how long people live without their cancer getting worse (progression-free survival) at 6 months after starting treatment. You may be eligible if you are 18 or older and have previously received surgery (if possible) and radiation for your meningioma.
- Study design
- This is a Phase II interventional study with a planned enrollment of 42 participants. It will evaluate two groups of meningioma: Grade I and Grade II/III.
- What's involved
- Participants will receive Lutetium Lu 177 Dotatate intravenously and Gallium Ga 68-DOTATATE intravenously. You will also undergo PET/MRI scans and complete questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures progression-free survival at 6 months after starting treatment.
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NCT04082520
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~42 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Gallium Ga 68-DOTATATELutetium Lu 177 DotatateMagnetic Resonance ImagingPositron Emission TomographyQuestionnaire AdministrationComputed Tomography
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival - 6 months
Measured over At 6 months after starting treatment
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Kenneth W. Merrell, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Previous treatment for meningioma including surgery, when possible, and radiation therapy (conventional fractionated or radiosurgery). Pathologic confirmation of meningioma is not required for patients who are not surgical candidates and received radiation therapy based on magnetic resonance imaging (MRI) consistent with meningioma. Patients with prior surgery will have pathologic confirmation of meningioma with either formalin-fixed paraffin-embedded (FFPE) tumor block OR meningioma tissue slides available for submission to central pathology review
Radiographic evidence of meningioma progression with measurable disease, defined as an increase in size of the measurable primary lesion on imaging by 15% or more (sum of the bidirectional measurements) in an approximate 6 month time period (i.e., calculated rate of growth 15% / 6 months based on available scans) or by the appearance of a new measurable lesion
Previous treatment with either fractionated radiation therapy or stereotactic radiosurgery at the site of progressive meningioma, without safe option for further radiotherapy
Willing to undergo 68Ga-DOTATATE PET imaging. 68Ga-DOTATATE PET imaging must be Krenning score must be a score of 2 or higher, suggesting somatostatin receptor expression, to be registered on the study. A PET/MRI is preferred, but PET/CT is permitted if a patient is not technically able to receive a PET/MRI or at the discretion of the primary investigator (PI).
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
Absolute neutrophil count (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 upper limit of normal (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)
Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 days prior to registration)
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants (obtained =\< 28 days prior to registration)
Calculated creatinine clearance must be \>= 40 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration) using the Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI) equation.
Ability to complete questionnaire(s) by themselves or with assistance
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) and it is highly recommend to see study staff in Radiation Oncology, Medical Oncology and/or Neuro-Oncology during the Event Monitoring Phase of the study.
Until 21 SPECT/CT slots are filled, willing to undergo SPECT/CT imaging for dosimetry analysis.
Exclusion
Eligibility for surgical or radiation treatment with curative intent
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
Pregnant women (NOTE: Patients with surgical sterilization or who have been post-menopausal for at least 2 years are excluded form pregnancy testing, but this must be documented.)
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Contraindications to or intolerance of MRI
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] II, III, IV), unstable angina pectoris, uncontrolled diabetes mellitus (fasting blood glucose \> 2 ULN), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Note: This includes treatment with somatostatin LAR within 4 weeks prior to enrollment, or any patient receiving treatment with short-acting octreotide that cannot be interrupted for greater than 24 hours before treatment
Other active malignancy =\< 2 years prior to registration
EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Current spontaneous urinary incontinence making impossible the safe administration of LUTATHERA
Untreated, refractory and/or symptomatic toxicity related to previous radiation therapy including radiation necrosis, radiation optic neuropathy, or radiation retinopathy
Optic nerve sheath meningioma, extracranial meningioma
What this trial measures
- Progression-free survival - 6 monthsAt 6 months after starting treatment
Defined as the number of evaluable patients not having progressive disease or death within six months of the first day of treatment.