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Lutetium Lu 177 dotatate

Radiopharmaceuticals

Patients receive gallium Ga 68-DOTATATE IV and undergo a PET/MRI or PET/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 SEPCT/CT dosimetry on study.

Gallium Ga 68-DOTATATE

Lutetium Lu 177 Dotatate

Magnetic Resonance Imaging

Positron Emission Tomography

Questionnaire Administration

Computed Tomography

Biospecimen Collection

Single Photon Emission Computed Tomography

Clinical Trials Referral Office

Kenneth W. Merrell, M.D.

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.

Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

A Prospective, Phase II Study of Lutetium Lu 177 Dotatate (LUTATHERA®) in Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy

QOL will be measured using the standard survey series for this population of patients, and QOL trajectory over time will be examined. The survey series includes Promise-10, Brief Fatigue Inventory, and Mayo Patient Survey National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Brain Symptom Index Questionnaire-24 (version 2). The main QOL impact will be measured with differences from baseline to 6, 12 and 24 months in patient reported outcomes via the symptom scales from the above surveys. All other QOL analyses will be exploratory and may include change from baseline to all time points using t-test and generalized linear models to test for changes at each time point and non-zero slopes, respectfully. No formal comparisons will be made among the cohorts.

Will be defined as a best objective response of stable disease, partial or complete response to treatment as determined by Macdonald Criteria. The proportion of patients who have achieved local control will be summarized by cohort and 95% confidence intervals calculated according to the methods described in Clopper-Pearson. No formal comparison will be made among the cohorts.

The distribution of local control and survival without progression as a competing risk model will be constructed using Kaplan-Meier estimates. No formal comparisons will be made amongst the cohorts.

Will be determined by Macdonald Criteria. The proportion of patients in each response category will be summarized by cohort and 95% confidence intervals calculated according to the methods described in Clopper-Pearson. No formal comparison will be made among the cohorts.

The response rate determined by volumetric analysis will be estimated for each cohort with proportion of patients who achieve complete response/partial response deemed by volumetric analysis. The 90% two-sided confidence intervals will be calculated according to approach of Clopper-Pearson. No formal comparison will be made among the cohorts.

Will be defined as the number of evaluable patients not having progressive disease or death within six months of the first day of treatment divided by the total number of evaluable patients. The proportion of successes in each cohort will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper-Pearson. There will be no formal comparison of rates among the two different grade cohorts of patients.

The distribution of survival time for both cohorts will be estimated using the method of Kaplan-Meier. No formal comparison will be made among the cohorts.

The distribution of time to progression will be estimated using the method of Kaplan-Meier (Kaplan et. al 1958). No formal comparison will be made among the cohorts.

Will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy	NCT04082520	Grade 1 Meningi... Grade 2 Meningi... Grade 3 Meningi... Recurrent Menin... Unresectable Me...	Gallium Ga 68-D... Lutetium Lu 177... Magnetic Resona... Positron Emissi... Questionnaire A... Computed Tomogr... Biospecimen Col... Single Photon E...	18 Years -	Mayo Clinic
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy	NCT04082520	Grade 1 Meningi... Grade 2 Meningi... Grade 3 Meningi... Recurrent Menin... Unresectable Me...	Gallium Ga 68-D... Lutetium Lu 177... Magnetic Resona... Positron Emissi... Questionnaire A... Computed Tomogr... Biospecimen Col... Single Photon E...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for unresectable meningioma