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.
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 meningioma during or after treatment of LUTATHERA. III. To determine the toxicity of LUTATHERA treatment in patients with recurrent meningioma. CORRELATIVE RESEARCH OBJECTIVES: I. To assess the impact of treatment on the patient's quality of life (QOL) using the Promise-10, Brief Fatigue Inventory (BFI), and Mayo Patient Survey National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Brain Symptom Index Questionnaire-24 (FBrSI-24) (version 2) instruments. II. To compare the response assessment between standard of care brain magnetic resonance imaging (MRI) and gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography (PET) imaging. III. To determine the best objective response (Macdonald criteria) of patients with recurrent meningioma during or after treatment of LUTATHERA. IV. To determine the duration of local control with death as a competing risk (by grade cohort) of patients with recurrent meningioma during or after treatment of LUTATHERA. V. To perform a quantitative dosimetric analysis of radiation dose delivered with lutathera: Va. To determine intratherapeutic dosimetry for the target meningioma; Vb. To correlate treatment response of lutathera with target dose received; Vc. To determine intratherapeutic dosimetry for kidneys and other abdominal organs. OUTLINE: Patients receive gallium Ga 68-DOTATATE intravenously (IV) and undergo a PET/MRI or PET/computed tomography (CT) before cycles 1 and 4. Patients then receive lutetium Lu 177 dotatate IV over 30-40 minutes. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI on study and during follow-up, as well as blood sample collection and possible single photon emission computed tomography (SPECT)/CT dosimetry on study. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Given IV
Given IV
Undergo PET/MRI
Undergo PET/MRI
Ancillary studies
Undergo PET/CT and/or SPECT/CT
Undergo blood sample collection
Undergo SPECT/CT
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGProgression-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.
Time frame: At 6 months after starting treatment
Overall survival
Defined as the time from the first day of treatment to death due to any cause.
Time frame: Up to 5 years
Progression free survival - overall
Defined as the time from the first day of treatment to the earliest date documentation of disease progression.
Time frame: Up to 5 years
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.
Time frame: Up to 24 months
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