Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment

Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis.

Patients with radiation-associated meningiomas.

Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column. Meningiomas invading the skull base or orbits are not excluded.

Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies.

Unstable neurological symptoms requiring steroids to control symptoms at a dose of \>2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration.

Patients requiring immediate local therapy (e.g. surgical resection).

Surgical procedure within the timeframes listed below, prior to step 2 registration.

28 days from any prior craniotomy

7 days from stereotactic biopsy Note: There is no limit to the number of prior surgical interventions

Treatment within the timeframes specified below, prior to step 2 registration.

28 days (or 5 half-lives, whichever is longer) for cytotoxic chemotherapy, biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma

6 weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.

A target lesion is excluded if it has received any of the following:

More than 2 total prior courses of radiation

More than 1 prior course of standard fractionated external beam radiation therapy (EBRT)

Radiation treatment to the target lesion completed \<24 weeks (168 days) before Step 2 registration.

For purposes of this criterion, one course of EBRT counts as one course regardless of duration, and each course of stereotactic radiation (1-5 fractions) counts as one course. Accordingly, a target lesion may have received at most one prior course of EBRT plus one prior course of stereotactic radiation, or two prior courses of stereotactic radiation. Prior radiation history must be evaluated on a lesion-by-lesion basis, including radiation delivered before any subsequent surgical resection.

All types of radioligand therapy at any time prior to registration. Radioligands received for diagnostic purposes are not exclusionary.

Known hypersensitivity to somatostatin analogues or any component of the \[68Ga\]Ga- DOTATATE or \[177Lu\]Lu-DOTATATE formulations.

Active infection requiring current use of intravenous therapy with antibiotics.

Active cardiovascular disease: cerebral vascular accident/stroke (≤ 6 months prior to registration), myocardial infarction (≤ 6 months prior to registration), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.

An active malignancy ≤ 3 years. Note: Patients with a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Pregnant and/or breastfeeding patients who are unwilling to discontinue breast feeding.

Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment

What this study is about

Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment

What this study is about