What is the mechanism of action of this treatment?

Common treatments for meningioma, particularly those similar to Lutathera, involve targeted radiation therapies that aim to destroy tumor cells while minimizing damage to surrounding healthy tissue. Lutathera, for example, is a radioactive drug that binds to specific receptors on tumor cells, delivering targeted radiation to kill these cells. This approach is crucial for meningioma patients, especially those with inoperable or progressive tumors, as it offers a non-surgical option to control tumor growth and improve outcomes. By focusing radiation precisely on the tumor, these treatments can reduce side effects and enhance the quality of life for patients.

What side effects are associated with this type of intervention?

Common treatments for meningioma, particularly those involving radioactive drugs like Lutathera, can have several side effects. These may include fatigue, nausea, vomiting, and hematologic toxicities such as neutropenia and anemia. Radiation therapy, a common treatment for meningioma, can also lead to skin irritation, hair loss at the treatment site, and potential long-term effects such as cognitive changes and an increased risk of secondary cancers. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of meningioma using radioactive drugs similar to Lutathera in the provided context. Lutathera itself is being studied in a phase II trial for treating inoperable, progressive meningioma after external beam radiation therapy. This suggests that Lutathera or similar radioactive drugs may not yet have FDA approval specifically for meningioma, and the study aims to determine its safety and efficacy for this condition.

What other types of research exist?

Currently, there are no specific novel alternatives to Lutathera mentioned for meningioma patients in the provided context. Patients should consult with their healthcare provider to explore ongoing clinical trials or emerging therapies in targeted treatments, immunotherapies, or novel chemotherapeutic agents for inoperable, progressive meningiomas.

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Radioactive Drug

Lutathera for Progressive Meningioma

Phase 2

Recruiting

Led By Kenneth W Merrell

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Willing to undergo 68Ga-DOTATATE PET imaging. 68Ga-DOTATATE PET imaging must be Krenning score must be a score of 2 or higher, suggesting somatostatin receptor expression, to be enrolled on the study

Radiographic evidence of meningioma progression with measurable disease, defined as an increase in size of the measurable primary lesion on imaging by 15% or more (sum of the bidirectional measurements) in an approximate 6 month time period (i.e., calculated rate of growth 15% / 6 months based on available scans) or by the appearance of a new measurable lesion

Must not have

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Optic nerve sheath meningioma, extracranial meningioma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well Lutathera works in treating patients with meningioma that cannot be treated with surgery and is getting worse after radiation therapy. Lutathera is a radioactive drug that targets and kills tumor cells. The goal is to see if it is safe and effective for these patients.

Who is the study for?

This trial is for adults with inoperable, progressive meningioma after radiation therapy. They must have had prior treatments like surgery if possible, show tumor growth on scans, and not be candidates for more radiotherapy. Participants need to have a certain level of physical fitness (ECOG PS <=2), adequate organ function, and agree to use contraception if applicable.

What is being tested?

The trial tests Lutathera's effectiveness and safety in treating meningiomas that worsen post-radiation. It involves radioactive drug infusion targeting cancer cells, alongside assessments through questionnaires, quality-of-life measures, MRI scans, and PET imaging using Gallium Ga 68-DOTATATE.

What are the potential side effects?

Potential side effects include reactions related to the infusion of a radioactive substance such as nausea or vomiting; blood count changes; kidney dysfunction; liver enzyme alterations; fatigue; allergic responses; and possibly others based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I agree to a 68Ga-DOTATATE PET scan and my scan shows a Krenning score of 2 or higher.

Select...

My meningioma has grown by 15% or more in the last 6 months.

Select...

I've had radiation for meningioma but can't safely have more.

Select...

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

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

Select...

I am not on any experimental drugs for my cancer.

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I have a tumor in the covering of my optic nerve or outside my brain.

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I am of childbearing age and do not plan to use birth control.

Select...

I am currently breastfeeding.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I have had serious side effects from previous radiation therapy.

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I am eligible for surgery or radiation aimed at curing my condition.

Select...

I cannot undergo MRI due to health reasons or past bad reactions.

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I do not have any severe illnesses that my doctor says could interfere with the study.

Select...

I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.

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I cannot control my bladder, which may affect my treatment safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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

Secondary study objectives

Incidence of adverse events

Overall survival

Progression free survival

Other study objectives

Change in quality of life (QOL)

Duration of local control

Local control

+2 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: Treatment (gallium Ga 68-DOTATATE PET/MRI, Lutathera)Experimental Treatment8 Interventions

Patients receive gallium Ga 68-DOTATATE IV and undergo a PET/MRI or PET/CT before cycles 1 and 4. Patients then receive lutetium Lu 177 dotatate IV over 30-40 minutes. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI on study and during follow-up, as well as blood sample collection and possible SEPCT/CT dosimetry on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~320

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Gallium Ga 68-DOTATATE

2018

Completed Phase 2

~30

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

0 / 15Eligibility 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

Common treatments for meningioma, particularly those similar to Lutathera, involve targeted radiation therapies that aim to destroy tumor cells while minimizing damage to surrounding healthy tissue. Lutathera, for example, is a radioactive drug that binds to specific receptors on tumor cells, delivering targeted radiation to kill these cells. This approach is crucial for meningioma patients, especially those with inoperable or progressive tumors, as it offers a non-surgical option to control tumor growth and improve outcomes. By focusing radiation precisely on the tumor, these treatments can reduce side effects and enhance the quality of life for patients.