RTOG Foundation, Inc.
This is an open-label, multicenter, randomized, phase 2 clinical study to evaluate the efficacy of \[177Lu\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.
Study participants will be randomized by a 2:1 ratio to receive either \[177Lu\]Lu-DOTATATE or standard of care therapy as deemed appropriate by the local investigator. At time of progression, participants on the standard of care arm may cross-over to the \[177Lu\]Lu-DOTATATE alternative treatment arm.
Inclusion Criteria: STEP 1 REGISTRATION * Aged \>= 18 years * Histologically confirmed diagnosis of WHO grade 1-3 meningioma * Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation. * The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation. * Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan defined as at least one lesion with two perpendicular diameters measuring ≥10 mm on two or more…
The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).
Treatments will occur at the discretion and based on clinical judgement of the local and treating investigator. Systemic SOC therapy with one of the following agents: bevacizumab, everolimus, or sunitinib.