Aspirin treatment for patients with vestibular schwannoma

Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas

This study is testing if taking aspirin can help delay tumor growth and protect hearing in people with vestibular schwannoma who are 12 years and older.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Massachusetts Eye and Ear Infirmary (Academic / other)
• Drugs / interventions: radiation
• Locations: 6 sites (Stanford, California and 5 other locations)
• Trial ID: NCT03079999 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the effectiveness of aspirin in delaying tumor growth and preserving hearing in patients diagnosed with vestibular schwannoma. Participants aged 12 and older will be randomly assigned to receive either 325 mg of aspirin twice daily or a placebo. The study will monitor tumor volume and hearing function over time, with patients continuing treatment as long as their tumor does not progress significantly. If progression occurs, patients will have the option to switch to unblinded aspirin and will be followed for up to 42 months.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12 and older with a radiographic diagnosis of vestibular schwannoma.

Not a fit: Patients with serious medical conditions or those who cannot tolerate MRI or aspirin will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option to manage tumor growth and maintain hearing in patients with vestibular schwannoma.

How similar studies have performed: While the use of aspirin for vestibular schwannoma is novel, other studies have explored similar approaches with varying degrees of success.

Eligibility criteria

Inclusion Criteria:

* Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic).
* Age≥12 years.
* Ability to provide informed consent.Pediatric patients must provide assent in addition to their parents'/guardians' consent. Adult patients who cannot consent for themselves will not be eligible to participate in this study.
* Ability to swallow tablets.

Exclusion Criteria:

* Inability to perform volumetric measurements of vestibular schwannoma(s).
* Inability to tolerate MRI with contrast.
* Daily use of aspirin within the last two months. Occasional use of aspirin for pain relief is not exclusionary.
* Known allergy to aspirin.
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of aspirin.
* Pregnant or lactating women.
* Patients with serious medical illnesses (e.g. severe asthma) that in the option of the investigator could prevent participation in the trial.
* Active bleeding diathesis.
* Hydrocephalus from brainstem compression.
* Febrile illness or flu-like illness in children and adolescents less than 18 years of age.

Where this trial is running

Stanford, California and 5 other locations

• Stanford Otolaryngology/HNS — Stanford, California, United States (Recruiting)
• University of Miami — Miami, Florida, United States (Recruiting)
• University of Iowa — Iowa City, Iowa, United States (Recruiting)
• Massachusetts Eye and Ear — Boston, Massachusetts, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Konstantina Stankovic, MD, PhD — Stanford University
• Study coordinator: Odeta Dyrmishi

Conditions Vestibular Schwannoma; Acoustic Neuroma; Neurofibromatosis 2