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.
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).
Eligibility for surgical or radiation treatment with curative intent
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
Single group
Gallium Ga 68-DOTATATE
RadiationGiven IV
Lutetium Lu 177 Dotatate
DrugGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo PET/MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET/MRI
Questionnaire Administration
Other interventionAncillary studies
Computed Tomography
Procedure/SurgeryUndergo PET/CT and/or SPECT/CT
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Single Photon Emission Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Progression-free survival - 6 months
Defined as the number of evaluable patients not having progressive disease or death within six months of the first day of treatment.
Overall survival
Defined as the time from the first day of treatment to death due to any cause.
Progression free survival - overall
Defined as the time from the first day of treatment to the earliest date documentation of disease progression.
Incidence of adverse events
Will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum grade for each type of adverse event will be recorded for each patient.
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