What side effects are associated with this type of intervention?

Common treatments for Acoustic Neuroma include surgery, radiation therapy, and medications like bevacizumab. Bevacizumab, an anti-angiogenic agent, has been shown to induce regression of vestibular schwannomas and improve hearing. However, it can cause side effects such as hypertension, proteinuria, and increased risk of bleeding. Aspirin, being studied for its potential to slow tumor growth and maintain hearing, may cause gastrointestinal issues, bleeding, and allergic reactions. Both treatments aim to manage tumor growth and preserve function but come with their respective risks.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved drugs for the treatment of Acoustic Neuroma (vestibular schwannoma) that focus on anti-inflammatory and anti-platelet effects similar to aspirin. Treatments like bevacizumab, an antiangiogenic agent, have been studied for their efficacy in reducing tumor growth and preserving hearing in patients with NF2-related vestibular schwannomas, but this is not an FDA-approved indication. Management of Acoustic Neuroma typically involves observation, surgical resection, or radiation therapy, depending on the size and symptoms of the tumor.

What other types of research exist?

Promising alternatives to aspirin for Acoustic Neuroma patients include Bevacizumab, which has shown efficacy in reducing tumor growth and improving hearing, and Everolimus and Lapatinib, which are being investigated for their potential benefits in managing vestibular schwannomas.

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Nonsteroidal Anti-inflammatory Drug

Aspirin for Acoustic Neuroma

Phase 2

Recruiting

Led By Konstantina Stankovic, MD, PhD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

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

Must have

Age≥12 years

Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic)

Must not have

Febrile illness or flu-like illness in children and adolescents less than 18 years of age

Hydrocephalus from brainstem compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up progression, or around 3.5 years

Summary

This trial is testing whether aspirin can slow tumor growth and improve hearing in patients aged 12+ with vestibular schwannomas. Aspirin's anti-inflammatory properties might help achieve these effects. Aspirin has been studied for its potential to protect against certain types of hearing loss and has shown some protective effects in previous studies.

Who is the study for?

This trial is for individuals aged 12 or older with a type of benign brain tumor called vestibular schwannoma, which can affect hearing. Participants must be able to swallow tablets and give informed consent; children need parental consent as well. People using daily aspirin, those allergic to it, pregnant women, and patients with severe illnesses like asthma or conditions affecting MRI scans cannot join.

What is being tested?

The study is testing if aspirin can slow down the growth of vestibular schwannomas and help maintain or improve hearing in affected patients. It's a phase II trial where participants are randomly assigned to receive either aspirin or a placebo without knowing which one they're getting.

What are the potential side effects?

Aspirin may cause side effects such as stomach upset, increased risk of bleeding, allergic reactions in some people, and possibly breathing difficulties in those with asthma.

Eligibility Criteria

Inclusion Criteria

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

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I am 12 years old or older.

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I have a tumor on my hearing and balance nerve, confirmed by imaging.

Exclusion Criteria

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

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My child is under 18 and currently has a fever or flu-like symptoms.

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I have fluid buildup in my brain due to pressure from a tumor.

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I currently have a bleeding disorder.

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My condition does not allow for measuring the size of my vestibular schwannoma.

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I have a stomach or intestine problem that affects how my body absorbs medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ progression, or around 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~progression, or around 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and progression, or around 3.5 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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AspirinExperimental Treatment1 Intervention

Patients on the experimental arm will receive blinded aspirin. Pediatric subjects who weigh less than 110 lbs will take 81mg aspirin twice a day. All other subjects will take 325mg aspirin twice a day.

Group II: PlaceboPlacebo Group1 Intervention

Patients on the placebo arm will receive blinded placebo and take it twice a day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin

2014

Completed Phase 4

~55580

0 / 7Eligibility 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 Acoustic Neuroma, such as bevacizumab and aspirin, work through different mechanisms. Bevacizumab is an antiangiogenic agent that inhibits vascular endothelial growth factor (VEGF), reducing tumor blood supply and growth. Aspirin, with its anti-inflammatory and anti-platelet effects, may slow tumor growth by reducing inflammation and inhibiting platelet aggregation, which can contribute to tumor progression. These mechanisms are crucial for Acoustic Neuroma patients as they offer non-surgical options that can potentially control tumor growth and preserve hearing, improving quality of life and reducing the need for invasive procedures.

Mechanisms of salicylate ototoxicity.Ototoxicity of salicylate, nonsteroidal antiinflammatory drugs, and quinine.Neuroprotective Effect of Valproic Acid on Salicylate-Induced Tinnitus.