What side effects are associated with this type of intervention?

Common side effects of treatments for meningioma using Lutathera (177Lu-DOTATATE) include nausea, vomiting, fatigue, and mild to moderate bone marrow suppression, which can lead to anemia, thrombocytopenia, and leukopenia. Serious adverse events, though less common, can include myelodysplastic syndrome and nephrotoxicity. These side effects are generally manageable with supportive care and monitoring.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for the treatment of meningioma using radiolabeled somatostatin analogs like Lutathera (177Lu-DOTATATE). Lutathera itself is approved for the treatment of somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The use of Lutathera for meningioma is currently being studied in clinical trials, indicating its potential but not yet established role in this context.

What other types of research exist?

Promising novel alternatives to Lutathera (177Lu-DOTATATE) for meningioma patients include other radiolabeled somatostatin analogs such as [177Lu]Lu-DOTA-ST8950, which targets somatostatin receptor subtypes 2 and 5. Additionally, emerging radioligand therapies like lutetium Lu 177 vipivotide tetraxetan, which has shown efficacy in other cancers, may also be considered. These alternatives offer targeted approaches similar to Lutathera, potentially providing effective treatment options for meningioma patients.

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Radioisotope Therapy

Lutathera for Meningioma

Phase 2

Waitlist Available

Led By Erik Sulman, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female subjects aged ≥ 18 years

Histologically confirmed diagnosis WHO grade I-III meningioma with specific criteria for each grade

Must not have

Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu-DOTATATE formulations

Active infection requiring intravenous therapy with antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Lutathera may include nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver toxicity, kidney damage including renal failure in severe cases and hormonal gland dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My meningioma is confirmed and graded I-III by a doctor.

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I can care for myself but may need occasional help.

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My latest tumor test shows positive for SSTR2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently on IV antibiotics for an infection.

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I have been diagnosed with NF2.

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I have another cancer that is getting worse or needs treatment.

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I have had peptide receptor radionuclide therapy before.

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I have a brain tumor linked to past radiation treatment.

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I do not have any uncontrolled illnesses like heart disease or active HIV/HBV/HCV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival at 6 months (PFS-6)

Secondary study objectives

Objective Response Rate (ORR)

Overall Survival (OS)

Overall Survival at 12 months (OS-12)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LutatheraExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lutathera

2022

N/A

~90

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lutathera (177Lu-DOTATATE) is a radiolabeled somatostatin analog that binds to somatostatin receptors on meningioma cells, delivering targeted radiation to kill the cancer cells. This targeted approach minimizes damage to surrounding healthy tissue, making it a valuable option for patients with somatostatin receptor-positive tumors. Other common treatments for meningioma include surgery, which physically removes the tumor; radiation therapy, which uses high-energy rays to destroy cancer cells; and chemotherapy, which uses drugs to kill rapidly dividing cells. Each treatment has its own mechanism and is chosen based on the tumor's characteristics and patient-specific factors, aiming to maximize efficacy while minimizing side effects.

Management of a Patient With Metastatic Gastrointestinal Neuroendocrine Tumor and Meningioma Submitted to Peptide Receptor Radionuclide Therapy With 177 Lu-DOTATATE.Neuroendocrine tumor theranostics.Extraventricular neurocytoma treated with 177Lu DOTATATE PRRT induction and maintenance therapies.