Phase II Study of Lutathera for Adults with Progressive or High-risk Meningioma

Inclusion Criteria

• Adults aged 18 and older.
• Must have a performance status score of 60 or higher, meaning they can care for themselves but may not be able to work.
• Diagnosed with WHO grade I-III meningioma:
  • For grade I, the tumor must have grown after surgery and radiation, or be in a risky location for radiation.
  • For grade II or III, the tumor must have grown after surgery and radiation, or still be present after surgery.
• Tumor must show positive uptake on a special PET-MRI scan.
• Must have at least one tumor that is 10 mm or larger on an MRI scan.
• Can have up to three measurable brain tumors.
• Neurological symptoms must be stable for at least 28 days before joining the study.
• No limit on previous surgeries or treatments.
• Must wait a certain time after previous treatments before joining.
• Must provide a tumor sample from the most recent surgery.
• Must be willing to have regular MRI scans.
• Must have recovered from previous treatment side effects.
• Must have adequate blood and organ function based on specific tests.
• Women and men must agree to use contraception during the study.
• Must be able to understand and sign a consent form.

Exclusion Criteria

• Diagnosis of NF2 or radiation-associated meningiomas.
• Currently receiving other investigational treatments for the tumor.
• Previous peptide receptor radionuclide therapy.
• Allergies to somatostatin analogues or components of the study drugs.
• Other active cancers needing treatment within the last 2 years, except certain skin or cervical cancers.
• Participation in another investigational study.
• Active infection needing IV antibiotics.
• Uncontrolled serious illnesses, including recent heart problems or stroke.
• Positive for HIV or active hepatitis B or C.
• Severe medical or psychiatric conditions that could affect participation.
• Pregnant or breastfeeding women. Women must have a negative pregnancy test before joining.