Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using Lutathera to treat inoperable, progressive meningioma after radiation therapy

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

Run by Mayo Clinic · NCT04082520 · Data updated 2026-11-12

This study is testing if a radioactive drug called Lutathera can help people with inoperable and progressive meningiomas feel better after they've had radiation therapy.

More Recurrent Meningioma trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment42 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionsradiation
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedApril 14, 2020
Main results expectedSeptember 4, 2027
Study endsMarch 4, 2032
Registry record updatedOctober 13, 2026
Trial IDNCT04082520 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with recurrent, inoperable meningiomas who have previously undergone radiation therapy and show evidence of disease progression.

Probably not a fit

Patients with meningiomas that are operable or those who have not received prior radiation therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of Lutathera, a radioactive drug, in treating patients with inoperable and progressive meningiomas following external beam radiation therapy. The study aims to evaluate the drug's safety and efficacy by measuring progression-free survival rates at six months for patients with recurrent grade 1, 2, or 3 meningiomas. Additionally, the trial will assess overall survival, treatment toxicity, and the impact on patients' quality of life using various assessment tools. Imaging techniques such as MRI and PET will be utilized to monitor treatment response.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat meningiomas, potentially improving survival and quality of life.

How similar studies have gone: While Lutathera has shown promise in treating other neuroendocrine tumors, this specific application for meningiomas is novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 registered on the study. A PET/MRI is preferred, but PET/CT is permitted if a patient is not technically able to receive a PET/MRI or at the discretion of the primary investigator (PI).
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
* Absolute neutrophil count (ANC) \>= 1500/mm (obtained =\< 28 days prior to registration)
* Platelet count \>= 100,000/mm (obtained =\< 28 days prior to registration)
* Hemoglobin \>= 9.0 g/dL (obtained =\< 28 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 =\< 28 days prior to registration)
* Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 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 =\< 28 days prior to registration)
* Calculated creatinine clearance must be \>= 40 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration) using the Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI) equation.
* 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) and it is highly recommend to see study staff in Radiation Oncology, Medical Oncology and/or Neuro-Oncology during the Event Monitoring Phase of the study.
* Until 21 SPECT/CT slots are filled, willing to undergo SPECT/CT imaging for dosimetry analysis.

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 (NOTE: Patients with surgical sterilization or who have been post-menopausal for at least 2 years are excluded form pregnancy testing, but this must be documented.)
  * 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 study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Contraindications to or intolerance of MRI
* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy

  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] II, III, IV), unstable angina pectoris, uncontrolled diabetes mellitus (fasting blood glucose \> 2 ULN), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* 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

  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
* History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Current spontaneous urinary incontinence making impossible the safe administration of LUTATHERA
* Untreated, refractory and/or symptomatic toxicity related to previous radiation therapy including radiation necrosis, radiation optic neuropathy, or radiation retinopathy
* Optic nerve sheath meningioma, extracranial meningioma

Where it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • RYZ101 (225Ac-DOTATATE) for progressive or recurrent intracranial meningioma

    This trial tests whether RYZ101, a radiopharmaceutical, can help people with growing or returning brain meningiomas that express somatostatin receptors.

    Recruiting Phase 1/2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07150806

  • Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma

    This study is testing a new way of giving radiation therapy over five days to see if it helps people with certain types of brain tumors feel better and have a better quality of life after treatment.

    Recruiting University of California, San Francisco · San Francisco, California · NCT06557512

  • Using 177Lu-DOTATATE to treat recurrent meningioma

    This study is testing if a new targeted treatment called 177Lu-DOTATATE can help people with recurrent meningioma who haven't had success with regular treatments like surgery and radiation.

    Recruiting at 17 sites Phase 2 European Organisation for Research and Treatment of Cancer - EORTC · Innsbruck and 18 other locations · NCT06326190

  • Treating progressive meningiomas with targeted therapies

    This study is testing if new targeted therapies can help people with progressive meningiomas who have certain genetic mutations feel better and live longer.

    Recruiting at 478 sites Phase 2 Alliance for Clinical Trials in Oncology · Birmingham, Alabama and 790 other locations · NCT02523014

  • Hypofractionated proton therapy for benign brain tumors

    This study is testing a new way of giving radiation therapy to see if it can help people with benign brain tumors feel better while causing fewer side effects.

    Recruiting Emory University · Atlanta, Georgia · NCT04278118

  • Treatment of high-grade meningioma with NEO100

    This study is testing a new treatment called NEO100 to see if it can help patients with high-grade meningioma that hasn't completely gone away after surgery.

    Recruiting at 5 sites Phase 2 Neonc Technologies, Inc. · Los Angeles, California and 4 other locations · NCT05023018

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.