A Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy

Overview

About this study

The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age ≥ 18 years.
  • 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 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) 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.
  • ECOG Performance Status (PS) ≤ 2.
  • The following laboratory values obtained ≤ 14 days prior to registration.
  • Absolute neutrophil count (ANC) ≥1500/mm.
  • Platelet count ≥100,000/mm.
  • Hemoglobin ≥ 9.0 g/dL.
  • 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).
  • Aspartate transaminase (AST) ≤ 3 x ULN.
  • PT/INR/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.
  • Calculated creatinine clearance must be ≥40 ml/min using the Cockcroft-Gault formula below:
    • Cockcroft-Gault Equation:
    • Creatinine clearance for males = (140 - age)(weight in kg)                (72)(serum creatinine in
           mg/dL)
    • Creatinine clearance for females = (140 - age)(weight in kg)(0.85)    (72)(serum creatinine in mg/dL)
  • 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.
  • 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;
    • 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 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 (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.
  • Significant toxicity related to previous radiation therapy including radiation necrosis, radiation optic neuropathy, or radiation retinopathy.
  • Optic nerve sheath meningioma, extracranial meningioma.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Merrell, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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More information

Publications

Publications are currently not available
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CLS-20467879

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