Status:
NOT_YET_RECRUITING
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
Lead Sponsor:
RTOG Foundation, Inc.
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Intracranial Meningioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed 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, partici...
Eligibility Criteria
Inclusion
- 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 to 5 measurable target lesions within the last 6 months, or
- ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, or
- Development of a new measurable lesion
- The following scans must be available for submission for central radiology review:
- Pre-progression gadolinium-enhanced MRI brain scan
- Progression gadolinium-enhanced MRI brain scan
- STEP 2 REGISTRATION
- Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as
- ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months, or
- ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, or
- Development of a new measurable lesion.
- \[68Ga\]Ga-DOTATATE uptake on PET-CT. Positive uptake is defined as uptake at least as high as liver, based on the uptake in at least one target lesion.
- If randomized to the control (standard of care) arm, both the patient and investigator must agree NOT to receive SSTR2-targeted therapy, surgical resection, or radiation therapy.
- Patients must be willing and able to undergo regular MRI scans of the brain and \[68Ga\]Ga-DOTATATE PET-CT imaging during the study.
- Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).
- Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration):
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 75,000/mm3
- Hemoglobin ≥ 8 g/dL
- Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min
- Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)
- Potassium within normal limits.
Exclusion
- 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.
- Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide.
- 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.
- Prior external beam radiation, interstitial brachytherapy or stereotactic radiosurgery cumulative radiation dose of \> 70 Gy or the last dose of radiotherapy \< 24 weeks (6 months) prior to step 2 registration
- Peptide receptor radionuclide therapy at any time prior to registration.
- 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.
Key Trial Info
Start Date :
November 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT06955169
Start Date
November 30 2025
End Date
August 1 2030
Last Update
November 13 2025
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