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Trials / Recruiting

RecruitingNCT04082520

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
41 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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 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.

Conditions

Interventions

TypeNameDescription
RADIATIONGallium Ga 68-DOTATATEGiven IV
DRUGLutetium Lu 177 DotatateGiven IV
PROCEDUREMagnetic Resonance ImagingUndergo PET/MRI
PROCEDUREPositron Emission TomographyUndergo PET/MRI
OTHERQuestionnaire AdministrationAncillary studies
PROCEDUREComputed TomographyUndergo PET/CT and/or SPECT/CT
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDURESingle Photon Emission Computed TomographyUndergo SPECT/CT

Timeline

Start date
2020-04-14
Primary completion
2026-07-06
Completion
2031-01-06
First posted
2019-09-09
Last updated
2025-12-11

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04082520. Inclusion in this directory is not an endorsement.