Study Comparing [177Lu]Lu-DOTATATE to Standard Treatment for Recurrent Meningioma

Sponsor: RTOG Foundation, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06955169

Provider View

This clinical trial is testing a new drug, [177Lu]Lu-DOTATATE, against the usual treatments for meningioma that has returned after previous treatment. The study aims to see if this new drug can better control the tumor's growth.

Patient Parameters

Program Overview

This study is looking at how effective a new treatment, [177Lu]Lu-DOTATATE, is for patients with meningioma, a type of brain tumor, that has come back after treatment. The trial will compare this new drug to the standard treatments currently used for meningioma. Participants will be randomly assigned to receive either the new drug or the standard treatment. If the tumor continues to grow, those on the standard treatment may switch to the new drug.

Description

Participants in this study will be randomly assigned to one of two groups: one group will receive the new drug [177Lu]Lu-DOTATATE, and the other will receive the standard treatment that their doctor thinks is best. If the tumor grows while on the standard treatment, participants can switch to the new drug. The study will help determine if [177Lu]Lu-DOTATATE is more effective in controlling the tumor compared to the usual treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of meningioma, grades 1 to 3.
  • Have a tumor that can be seen on an MRI scan, with at least one tumor measuring 10 mm or larger.
  • The tumor must have grown by at least 15% in the last 6 months or 25% in the last year, or a new tumor must have appeared.
  • Must have MRI scans available for review.
  • Must show positive uptake on a specific PET-CT scan.
  • If assigned to standard treatment, must agree not to receive certain other therapies.
  • Must be willing to have regular MRI and PET-CT scans.
  • Must have recovered from any significant side effects of previous treatments.
  • Must have adequate organ and bone marrow function, as shown by specific blood tests.

Exclusion Criteria

  • Cannot have a diagnosis related to NF2-related schwannomatosis.
  • Cannot have meningiomas caused by previous radiation.
  • Cannot have meningiomas outside the skull or spine.
  • Cannot have had certain targeted therapies before.
  • Cannot have unstable symptoms needing high doses of steroids.
  • Cannot need immediate surgery.
  • Cannot have had recent surgery or treatment within specific timeframes.
  • Cannot have had high doses of previous radiation.
  • Cannot have had certain types of therapy before.
  • Cannot be allergic to components of the study drugs.
  • Cannot have active infections needing IV antibiotics.
  • Cannot have serious heart conditions or recent heart attacks or strokes.
  • Cannot have another active cancer within the last 3 years.
  • Cannot be pregnant or breastfeeding without agreeing to stop breastfeeding.
  • Must have a negative pregnancy test if of childbearing potential.

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