A Prospective, Phase II Study of Lutetium Lu 177 Dotatate (LUTATHERA®) in Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Mayo Clinic
Summary
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.
Description
PRIMARY OBJECTIVES: I. To estimate the efficacy of lutetium Lu 177 dotatate (LUTATHERA) treatment in patients with recurrent grade 1 meningioma as measured by 6-month progression-free survival (PFS) rate. II. To estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate. SECONDARY OBJECTIVES: I. To determine the overall survival (by grade cohort) of patients with recurrent meningioma during or after treatment of LUTATHERA. II. To determine the progression-free survival (by grade cohort) of patients with recurrent meningi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 eviden…
Interventions
- RadiationGallium Ga 68-DOTATATE
Given IV
- DrugLutetium Lu 177 Dotatate
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo PET/MRI
- ProcedurePositron Emission Tomography
Undergo PET/MRI
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureComputed Tomography
Undergo PET/CT and/or SPECT/CT
- ProcedureBiospecimen Collection
Location
- Mayo Clinic in RochesterRochester, Minnesota