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

  • STATUS
    Recruiting
  • End date
    Sep 4, 2025
  • participants needed
    41
  • sponsor
    Mayo Clinic
Updated on 24 May 2022

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 cancer cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment.

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), European Quality of Life Five Dimension Five Level (EQ-5D-5L), 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 (McDonald 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 before cycles 1 and 4. Patients then receive lutetium Lu 177 dotatate intravenously (IV) over 30-40 minutes. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Details
Condition Grade 1 Meningioma, Grade 2 Meningioma, Grade 3 Meningioma, Recurrent Meningioma, Unresectable Meningioma
Treatment questionnaire administration, quality-of-life assessment, magnetic resonance imaging, positron emission tomography, Gallium Ga 68-DOTATATE, Lutetium Lu 177 Dotatate
Clinical Study IdentifierNCT04082520
SponsorMayo Clinic
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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 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 enrolled on the study
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
Absolute neutrophil count (ANC) >= 1500/mm (obtained =< 14 days prior to registration)
Platelet count >= 100,000/mm (obtained =< 14 days prior to registration)
Hemoglobin >= 9.0 g/dL (obtained =< 14 days prior to registration)
Direct bilirubin < 1.5 x upper limit of normal (ULN) (or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert's syndrome) (obtained =< 14 days prior to registration)
Aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to registration)
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants (obtained =< 14 days prior to registration)
Calculated creatinine clearance must be >= 40 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Note: A negative pregnancy test needs to be done within 48 hours of receiving LUTATHERA treatment
Note: Patients with surgical sterilization or who have been post-menopausal for at least 2 years are excluded from pregnancy testing, but this must be documented
Ability to complete questionnaire(s) by themselves or with assistance
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136
Note: The blood draw is optional

Exclusion Criteria

Eligibility for surgical or radiation treatment with curative intent
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this
Contraindications to or intolerance of MRI
study or interfere significantly with the proper assessment of safety and
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
toxicity of the prescribed regimens
Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Note: This includes treatment with somatostatin LAR within 4 weeks prior to enrollment, or any patient receiving treatment with short-acting octreotide that cannot be interrupted for greater than 24 hours before treatment
Other active malignancy =< 2 years prior to registration
Uncontrolled intercurrent illness including, but not limited to, ongoing or active
Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
infection, symptomatic congestive heart failure (New York Heart Association
Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
[NYHA] II, III, IV), unstable angina pectoris, uncontrolled diabetes mellitus
(fasting blood glucose > 2 ULN), cardiac arrhythmia, or psychiatric
Current spontaneous urinary incontinence making impossible the safe administration of LUTATHERA
illness/social situations that would limit compliance with study requirements
Significant toxicity related to previous radiation therapy including radiation necrosis, radiation optic neuropathy, or radiation retinopathy
Optic nerve sheath meningioma, extracranial meningioma
History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular
arrhythmias
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