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MeningiomaPhase 2NCT03971461

Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma

A Phase 2 study testing Lutathera in people with Meningioma, run by NYU Langone Health at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
Lutathera
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
15 May 2019to Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged ≥ 18 years.
  • Karnofsky Performance Status ≥ 60.
  • Histologically confirmed diagnosis WHO grade I-III meningioma:
  • For grade I meningioma, subjects must have: i. Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bidirectional area) on imaging by 25% or more between scans separated by no more than 12 months.
  • or ii. Progressive residual tumor after maximal safe resection, be located at or near critical organs at-risk and considered to be high-risk for radiation injury by the treating investigator. Prior external beam radiotherapy is not required for these subjects.
  • For Grade II or III meningioma, subjects must have either: i. Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bi-directional area) on imaging by 25% or more between scans separated by no more than 12 months or ii. Residual measurable disease after surgery without requirement of progression.
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  • Positive 68Ga-DOTATATE uptake on PET-MRI.
  • Positive uptake is defined as uptake higher than the background and SUV ratios adjusted to the liver and spleen uptake (adopted from Krenning score).
  • 68Ga-DOTATATE uptake in target lesions should be Krenning score ≥ 2.
  • Presence of measurable disease defined as at least one lesion measuring ≥10 mm in at least one dimension by contrast-enhanced MRI performed within 30 days prior to study registration.
  • Multifocal disease is allowed but is limited to ≤ 3 measurable intracranial mass lesions on the most recent post-contrast MRI.
  • Any neurological symptoms must be stable for at least 28 days prior to enrollment and patients should not require steroids to control neurological symptoms.
  • There is no limit on the number of prior surgeries, radiation therapy, radiosurgery treatments or systemically administered therapeutic agents.
  • For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval ≥24 weeks must have elapsed from completion from these therapies to registration unless there is histopathologic confirmation of recurrent tumor or there is new enhancing tumor outside the radiation field (beyond the high dose region or the 80% isodose line).
  • An interval of ≥28 days (or 5 half-lives, whichever is shorter) from prior cytotoxic chemotherapy (6 weeks from nitrosoureas), biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma.
  • An interval of ≥28 days from craniotomy and ≥7 days from stereotactic biopsy.
  • Availability of a paraffin-embedded archival tumor block from most recent tumor resection sufficient to generate at minimum 8 unstained slides but preferably up to 25 unstained slides; or, if a paraffin tumor block is unavailable, at minimum 8 unstained slides but preferably up to 25 unstained slides.
  • Positive SSTR2 expression in the most recent tumor specimen must be confirmed by central pathology review.
  • Patients must be willing and able to undergo regular MRI scans of the brain.
  • Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, laboratory values listed per inclusion criteria, 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 21 days of treatment initiation):
  • White blood cell (WBC) ≥ 2,000/mm3
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3
  • Platelet count ≥ 75,000/mm3
  • Hemoglobin ≥ 8 gm/dL
  • AST(SGOT)/ALT(SGPT) ≤ 3 x laboratory upper limit of normal (ULN)
  • Creatinine clearance (measured or calculated) ≥ 50 mL/min OR creatinine levels > 150 μMol/L (1.7 mg/dL)
  • Total serum bilirubin ≤ 3 X ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 X ULN)
  • Serum albumin level of more than 3.0 g/dL, unless the prothrombin time value was within the normal range
  • Women of childbearing potential (WOCBP) and men able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in the study, she must inform her treating physician immediately.
  • Able to understand and willing to sign an IRB approved written informed consent document.

Who cannot join

  • Patients with a clinical diagnosis of NF2 (either by NIH or Manchester criteria) or with a molecular diagnosis of NF2.
  • Patients with radiation-associated meningiomas.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. This includes treatment with Somatostatin LAR within 4 weeks prior to treatment, or any patient receiving treatment with short-acting Octreotide that cannot be interrupted for greater than 24 hours before treatment.
  • Peptide receptor radionuclide therapy at any time prior to registration.
  • Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu-DOTATATE formulations.
  • Known additional malignancy that is progressing or requires active treatment within 2 years of start of study drug. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone potentially curative therapy.
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  • Current or planned participation in another study of an investigational agent or investigational device.
  • Active infection requiring intravenous therapy with antibiotics.
  • Uncontrolled intercurrent illness including, but not limited to, clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive).
  • Other severe acute or chronic medical or psychiatric conditions (within the past year) including recent or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or treatment on study or may interfere with the interpretation of study results.
  • Pregnant and/or breastfeeding patients. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 14 days of study entry.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: A Single Arm, Open-label, Multicenter Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma

This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Ga-DOTATATE PET-MRI scans will be obtained prior to initiation of Lutathera treatment and 6 months after the initiation of Lutathera treatment. The latter will be performed within the 14 days prior to the last dose of Lutathera treatment.

Conditions
Meningioma
Being tested
Lutathera
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LutatheraDrug

    Also called 177Lu-DOTATATE

    administered intravenously every 8 weeks for a total of 4 doses

Study groups in NCT03971461
Study groupRoleWhat they receive
LutatheraExperimentalNot described
Receives: Drug: Lutathera

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival at 6 months (PFS-6)

    proportion of subjects who achieve a complete response (CR), partial response (PR), or stable disease (SD) at 6 months from start of Lutathera treatment. Radiographic treatment response will be assessed by measuring the bidirectional tumor diameters on contrast-enhanced MRI in patients who received at least one dose of Lutathera compared to baseline measurements at time of study enrollment

    Measured: 6 Months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    defined as the best response [Complete Response (CR) + Partial Response (PR) + stable disease (SD)] recorded from the start of the study until the end of study in patients who received at least one dose of Lutathera.

    Measured: 12 months

  2. Overall Survival at 12 months (OS-12)

    proportion of subjects who are alive at 12 months from start of Lutathera treatment. Survival data will be captured by clinical follow-up every 8 weeks during treatment with Lutathera and by follow-up phone calls every 12 weeks for up to 2 years after completion of treatment with Lutathera.

    Measured: 12 months

  3. Progression Free Survival (PFS)

    defined as the number of days from the treatment start date to the date of documented disease progression or death due to any cause.

    Measured: 2 Years Post Treatment

  4. Overall Survival (OS)

    defined as the number of days from the treatment start date to the date of death due to any cause.

    Measured: 2 Years Post Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start15 May 2019
  3. Primary completion18 Apr 2025
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single arm, multicenter, two-stage phase 2 clinical study.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03971461
Sponsor's protocol ID
18-00719
Status last verified
Sep 2026
First submitted
30 May 2019
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutathera in people with Meningioma, run by NYU Langone Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival at 6 months (PFS-6) (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03971461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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