- Karnofsky Performance Status ≥ 60.
- Histologically confirmed diagnosis WHO grade I-III meningioma:
- For grade I meningioma, subjects must have:
- Progressive disease after at least surgical resection and radiotherapy, as defined as
an increase in size of the measurable primary lesion (bidirectional area) on imaging
by 25% or more between scans separated by no more than 24 months.
- Progressive residual tumor after maximal safe resection, be located at or near
critical organs at-risk  and considered to be high-risk for radiation injury by
the treating investigator. Prior external beam radiotherapy is not required for these
- For Grade II or III meningioma, subjects must have either:
- Progressive disease after at surgical resection and radiotherapy, as defined as an
increase in size of the measurable primary lesion (bi-directional area) on imaging by
25% or more between scans separated by no more than 24 months
- Residual measurable disease after surgery without requirement of progression.
- Positive 68Ga-DOTATATE uptake on PET-MRI.
- Positive uptake is defined as uptake higher than the background and SUV ratios
adjusted to the liver and spleen uptake (adopted from Krenning score).25
- Presence of measurable disease defined as at least one lesion measuring ≥10 mm in at
least one dimension by contrast-enhanced MRI performed within 30 days prior to study
- Multifocal disease, meningioma with extra-cranial spread, spinal meningiomas, and
metastatic meningiomas (as defined by extracranial meningiomas) are allowed.
- There is no limit on the number of prior surgeries, radiation therapy, radiosurgery
treatments or systemically administered therapeutic agents.
- For patients treated with external beam radiation, interstitial brachytherapy or
radiosurgery, an interval ≥24 weeks must have elapsed from completion from these
therapies to registration unless there is histopathologic confirmation of recurrent
tumor or there is new enhancing tumor outside the radiation field (beyond the high
dose region or the 80% isodose line).
- An interval of ≥28 days (or 5 half-lives, whichever is shorter) from prior cytotoxic
chemotherapy (6 weeks from nitrosoureas), biologic agent, investigational agent or any
other systemic agent prescribed for the purpose of treating meningioma.
- An interval of ≥28 days from craniotomy and ≥7 days from stereotactic biopsy.
- Availability of a paraffin-embedded archival tumor block sufficient to generate at
least 25 unstained slides; or, if a paraffin tumor block is unavailable, at least 25
- Patients must be willing and able to undergo regular MRI scans of the brain.
- Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from
clinically significant adverse events related to prior therapy (exclusions include
alopecia, laboratory values listed per inclusion criteria, lymphopenia, sensory
neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the
- Adequate organ and bone marrow function as defined below (within 21 days of treatment
- Women of childbearing potential (WOCBP) and men able to father a child must agree to
use adequate contraception (hormonal or barrier method of birth control, abstinence)
prior to study entry and for the duration of study participation. Should a woman
become pregnant or suspect she is pregnant while participating in the study, she must
inform her treating physician immediately.
- Able to understand and willing to sign an IRB approved written informed consent
- Participants with a clinical diagnosis of NF2 (either by NIH or Manchester criteria)
or with a molecular diagnosis of NF2.
- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm. This includes treatment with Somatostatin LAR within 4 weeks
prior to treatment, or any patient receiving treatment with short-acting Octreotide
that cannot be interrupted for greater than 24 hours before treatment.
- Peptide receptor radionuclide therapy at any time prior to registration.
- Known hypersensitivity to somatostatin analogues or any component of the 68Ga-
DOTATATE or 177Lu-DOTATATE formulations.
- Known additional malignancy that is progressing or requires active treatment within 2
years of start of study drug. Exceptions include basal cell carcinoma of the skin,
squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone
potentially curative therapy.
- Current or planned participation in another study of an investigational agent or
- Active infection requiring intravenous therapy with antibiotics.
- Uncontrolled intercurrent illness including, but not limited to, clinically
significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (<
6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment),
congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious
cardiac arrhythmia requiring medication.
- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS).
- Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
(positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is
- Other severe acute or chronic medical or psychiatric conditions (within the past year)
including recent or active suicidal ideation or behavior, or laboratory abnormalities
that may increase the risk associated with study participation or treatment on study
or may interfere with the interpretation of study results.
- Pregnant and/or breastfeeding patients. Women of childbearing potential (WOCBP) must
have a negative pregnancy test within 14 days of study entry.