Study of Aspirin in Patients With Vestibular Schwannoma

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in VS patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborators: Massachusetts General Hospital; United States Department of Defense
• Treatments: Aspirin

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.