MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma
RTOG Foundation, Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: STEP 1 REGISTRATION * Aged \>= 18 years * Histologically confirmed diagnosis of WHO grade 1-3 meningioma * 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 axial slices (≤ 5 mm interslice thickness, ≤ 1 mm interslice gap) per current RANO meningioma criteria * Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as * ≥ 15% increase in sum of product of perpendicular measurements of up…
Interventions
- Drug[177Lu]Lu-DOTATATE
The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).
- OtherStandard of Care treatments
Treatments will occur at the discretion and based on clinical judgement of the local and treating investigator. Local SOC therapy with one of the following agents: bevacizumab, everolimus, hydroxyurea, or sunitinib.
Locations (11)
- University of California San Diego - Moores Cancer CenterLa Jolla, California
- Yale UniversityNew Haven, Connecticut
- Baptist MD Anderson Cancer CenterJacksonville, Florida
- University of MiamiMiami, Florida
- Baptist Health Medical Group OncologyMiami, Florida
- Piedmont HealthcareAtlanta, Georgia