Actively Recruiting
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
Led by RTOG Foundation, Inc. · Updated on 2026-05-14
153
Participants Needed
12
Research Sites
240 weeks
Total Duration
On this page
Sponsors
R
RTOG Foundation, Inc.
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged �3E= 18 years
- Histologically confirmed diagnosis of WHO grade 1-3 meningioma
- Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan with at least one lesion �3E=10 mm on two or more axial slices
- Disease progression confirmed by local radiology review per RANO criteria within the last 6 to 12 months or new measurable lesion
- Availability of pre-progression and progression gadolinium-enhanced MRI brain scans for central review
- Disease progression confirmed by central radiology review per RANO criteria
- Positive [68Ga]Ga-DOTATATE uptake on PET-CT, defined as uptake at least as high as liver in at least one target lesion
- Agreement not to receive SSTR2-targeted therapy, surgery, or radiation if randomized to standard care arm
- Willingness and ability to undergo regular MRI and PET-CT scans during the study
- Recovery to CTCAE grade �3C=1 or baseline from prior therapy adverse events (excluding some low-grade conditions)
- Adequate organ and bone marrow function within 28 days prior to step 2 registration including ANC �3E=1500/mm3, platelets �3E=75,000/mm3, hemoglobin �3E=8 g/dL, creatinine clearance �3E=40 mL/min, bilirubin �3C=3 x ULN (or �3C=5 x ULN with Gilbert's Syndrome), normal potassium levels
You will not qualify if you...
- Clinical or molecular diagnosis of NF2-related schwannomatosis
- Radiation-associated meningiomas
- Known intraspinal meningiomas or meningioma metastases outside skull/spinal column
- Prior somatostatin receptor-targeted therapy (e.g., Somatostatin LAR, Octreotide)
- Unstable neurological symptoms requiring >2 mg daily dexamethasone within 28 days prior to step 2
- Need for immediate local therapy such as surgery
- Recent surgery within 28 days for craniotomy or 7 days for stereotactic biopsy
- Recent systemic treatment for meningioma within specified timeframes (28 days or 5 half-lives for most agents, 6 weeks for nitrosoureas)
- Prior radiation exceeding 70 Gy cumulative dose or radiotherapy within 24 weeks prior to step 2
- Previous peptide receptor radionuclide therapy
- Known allergy to somatostatin analogues or components of [68Ga]Ga-DOTATATE or [177Lu]Lu-DOTATATE
- Active infection requiring intravenous antibiotics
- Active cardiovascular disease within 6 months or serious arrhythmia requiring medication
- Active malignancy within past 3 years unless unlikely to interfere with study
- Pregnant or breastfeeding without willingness to stop breastfeeding
- Childbearing potential participants without negative pregnancy test within 14 days of study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
University of California San Diego - Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
5
University of Miami
Miami, Florida, United States, 33146
Actively Recruiting
6
Baptist Health Medical Group Oncology
Miami, Florida, United States, 33176
Actively Recruiting
7
Piedmont Healthcare
Atlanta, Georgia, United States, 30318
Actively Recruiting
8
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Duke University Medical Center
Durham, North Carolina, United States, 22708
Actively Recruiting
12
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Sylvia C Kurz, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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