Lutathera for Meningioma

Not currently recruiting at 1 trial location

Overseen By Erika Waalkes

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must not be taking: Somatostatin, Octreotide

Disqualifiers: NF2, Radiation-associated meningiomas, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Lutathera, administered through an IV, to determine its effectiveness for meningioma, a type of brain tumor that is worsening or poses a high risk of complications. Researchers aim to discover if Lutathera can halt or slow the tumor's growth. Suitable candidates for this trial include those with a confirmed meningioma that has grown after surgery and radiation or remains after surgery, as detected on a specific brain scan. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that treatment with Somatostatin LAR must be stopped 4 weeks before the trial, and short-acting Octreotide must be stopped for more than 24 hours before treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Lutathera is likely to be safe for humans?

Research shows that Lutathera (177Lu-DOTATATE) is being tested for safety and effectiveness in treating meningioma, a type of brain tumor. Studies have found that Lutathera is generally well-tolerated, meaning most people can use it without serious problems. One study found it safe to use, with no severe side effects reported. Another study confirmed its safety in treating brain tumors and suggested it might even help people live longer.

These results encourage those considering joining a trial. While researchers continue to study Lutathera for meningioma, the FDA has already approved it for another type of cancer, boosting confidence in its safety. However, like any treatment, there may be some risks. Discussing options with a healthcare provider can help in making an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lutathera is unique because it targets tumor cells with a mechanism called peptide receptor radionuclide therapy (PRRT), which delivers radiation directly to the cancer cells via a specific receptor. Unlike traditional treatments for meningioma, such as surgery or radiation therapy, Lutathera specifically binds to somatostatin receptors that are often overexpressed in these tumors, allowing for targeted radiation delivery that minimizes damage to surrounding healthy tissues. Researchers are excited about this treatment because it offers a more precise approach, potentially leading to better outcomes with fewer side effects.

What evidence suggests that Lutathera might be an effective treatment for meningioma?

Research has shown that Lutathera, also known as 177Lu-DOTATATE, can help treat meningioma, a type of brain tumor. Studies have found that it targets specific receptors often present on these tumors. For patients whose meningiomas do not respond to other treatments, Lutathera has proven safe and effective in stopping tumor growth. It has also benefited patients whose tumors did not improve with surgery or radiation. Overall, evidence suggests that Lutathera can be a good option for managing hard-to-treat meningiomas. ^{1 2 3 4 5}

Who Is on the Research Team?

Erik Sulman, MD

Principal Investigator

New York Langone Health

Are You a Good Fit for This Trial?

Adults with progressive or high-risk meningioma who show positive uptake on PET-MRI scans and have tumors expressing SSTR2. Participants must be over 18, able to undergo regular MRI scans, have stable neurological symptoms for at least a month before joining, and good organ function. They should not be pregnant, breastfeeding, or have had certain other treatments like peptide receptor radionuclide therapy.

Inclusion Criteria

Willingness and ability to undergo regular MRI scans of the brain

There is a sample of your tumor tissue preserved in wax or on slides for review by a pathologist.

Ability to understand and willing to sign an IRB approved written informed consent document

Exclusion Criteria

Current or planned participation in another study of an investigational agent or investigational device

Pregnant and/or breastfeeding patients

I am allergic to somatostatin analogues or components in 68Ga-DOTATATE or 177Lu-DOTATATE treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses

32 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up phone calls every 12 weeks

Imaging

Ga-DOTATATE PET-MRI scans obtained prior to initiation and 6 months after initiation of Lutathera treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lutathera

Trial Overview The trial is testing Lutathera (177Lu-DOTATATE), given intravenously every two months for four doses total. Patients will get PET-MRI scans before starting treatment and six months after to see how effective the drug is against meningioma that lights up on these special scans.

How Is the Trial Designed?

Group I: Lutathera Experimental Treatment 1 Intervention

Lutathera is already approved in United States, European Union for the following indications:

Approved in United States as Lutathera for:

• Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults and pediatric patients 12 years and older

Approved in European Union as Lutathera for:

• Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study of 219 Lutathera injections over 70 months, using a peristaltic pump (method 2) resulted in a 34.9% reduction in residual radioactivity compared to a volumetric infusion pump (method 1), indicating improved efficiency in drug delivery.

Despite method 2 having a higher cost per injection, it was reported to be safer and more suitable by operators, with no major incidents occurring during its use, suggesting it may be a better option for future radioligand therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

177Lu-Dotatate administration using an infusion pump or a peristaltic pump: comparison of two methods. Donzé, C., Rubira, L., Santoro, L., et al.[2022]

Lutetium Dotatate (Lutathera) is an FDA-approved radiopharmaceutical therapy for treating somatostatin receptor positive neuroendocrine tumors, allowing for effective outpatient treatment.

The study confirms that Lutathera can be safely administered on an outpatient basis, provided that patients are informed about safety measures and travel restrictions related to radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Release and Instructions for Lutetium Dotatate Radiopharmaceutical Therapy. Underwood, J., Sturchio, G., Arnold, S.[2023]

The study successfully demonstrated that pharmacokinetic parameters of Lu-177 DOTATATE can be derived from SPECT/CT imaging, allowing for non-invasive monitoring of drug distribution in patients with neuroendocrine tumors.

The findings revealed significant differences in drug clearance and distribution between blood and bone marrow, suggesting that individual patient characteristics, such as weight, can be used to optimize personalized dosing strategies for improved treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Pharmacokinetics of Radiopharmaceuticals from SPECT/CT Image Acquisition by Contouring in Patients with Gastroenteropancreatic Neuroendocrine Tumors: Lu-177 DOTATATE (Lutathera®) Case. Barakat, A., Santoro, L., Vivien, M., et al.[2023]

In a study of 79 patients with progressive neuroendocrine tumors treated with Lu-DOTATATE, 13% showed a partial response and 64% had stable disease, with a median time to progression of 28 months overall.

The treatment was found to be safe, with only a few patients experiencing mild toxicity, including grade 1 haematotoxicity and nephrotoxicity, supporting its use as an effective option for managing these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET. Pencharz, D., Walker, M., Yalchin, M., et al.[2019]

A 62-year-old man with recurrent anaplastic meningioma showed significant tumor progression despite previous treatments, but was treated with Lutetium Lu 177 dotatate, which was well-tolerated with no notable adverse events.

After initial tumor growth following the first treatment cycle, the tumor volume stabilized and showed a decrease after the second cycle, indicating potential efficacy of Lutetium Lu 177 dotatate in managing this aggressive tumor type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of 177Lu-Dotatate Therapy in the Treatment of Recurrent Meningioma. Zahid, A., Johnson, DR., Kizilbash, SH.[2022]

Lutetium-177 dotatate (Lutathera®) is an effective outpatient treatment for neuroendocrine tumors, administered in four cycles of 7.4 GBq each, with minimal radiation exposure to staff and surrounding areas when proper safety protocols are followed.

The treatment can be safely conducted in standard hospital procedural rooms without the need for extra shielding, provided that precautions are taken to manage radiation exposure and contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Safety Observations Associated with 177Lu Dotatate Patients. Nelson, KL., Sheetz, MA.[2020]

Citations

1. redjournal.org redjournal.org/article/S0360-3016(24)00765-X/fulltext

A Prospective, Phase II Study of 177Lu-Dotatate in Patients ... As nearly all meningiomas express somatostatin receptors, we evaluated the efficacy of lutetium-177 ( 177 Lu)–Dotatate for refractory meningioma.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528330/

Efficacy of Intra-arterial [177Lu]Lu-DOTATATE monotherapy ... In a treatment-refractory meningioma cohort, intra-arterial administration of [177Lu]Lu-DOTATATE is safe and effective, with an objective ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/08/07/jnumed.125.269633

[177Lu]Lu-DOTATATE for Recurrent Meningioma (LUMEN-1 ... [177Lu]Lu-DOTATATE has been investigated in several small and uncontrolled studies of patients with meningioma (10,11). A recent individual ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05278208

Lutathera for Treatment of Recurrent or Progressive High ... This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System ...

5. targetedonc.com targetedonc.com/view/177lu-dotatate-is-a-viable-treatment-in-meningioma

177Lu-Dotatate Is a Viable Treatment in Meningioma Lutetium 177 dotatate showed activity and met the PFS end point in patients with surgery- or radiation-refractory grade 2/3 meningioma, per a phase 2 trial.