Lutathera for Meningioma

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

32 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Lutathera for treating meningioma?

A case study showed that Lutathera (Lutetium Lu 177 dotatate) was used to treat a patient with recurrent meningioma, resulting in a decrease in tumor size after initial treatment cycles and stable tumor volume eight months after treatment began. ^{1 2 3 4 5}

Is Lutathera safe for human use?

Lutathera (Lutetium Lu 177 dotatate) has been used safely in patients with neuroendocrine tumors, with minimal radiation exposure to others and no notable adverse events reported in a case of meningioma treatment. ^{1 2 3 4 5}

How is the drug Lutathera different from other treatments for meningioma?

Lutathera is unique because it is a radiopharmaceutical therapy that uses a radioactive substance to target and treat tumors, specifically those with somatostatin receptors, which is different from traditional chemotherapy or surgery. It is administered intravenously and can be done on an outpatient basis, making it more convenient for patients. ^{1 4 5 6 7}

What is the purpose of this trial?

This trial tests Lutathera, a targeted radiation therapy given through an IV, in patients with certain types of growing or high-risk brain tumors. The treatment aims to destroy tumor cells using targeted radiation.

Research Team

Erik Sulman, MD

Principal Investigator

New York Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Radiation Safety Observations Associated with 177Lu Dotatate Patients. [2020]

2. France 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of 177Lu-Dotatate Therapy in the Treatment of Recurrent Meningioma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Patient Release and Instructions for Lutetium Dotatate Radiopharmaceutical Therapy. [2023]

6. England pubmed.ncbi.nlm.nih.gov

177Lu-Dotatate administration using an infusion pump or a peristaltic pump: comparison of two methods. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Consequences of meta-stable (177m)Lu admixture in (177)Lu for patient dosimetry. [2019]