Study of Aspirin in Patients With Vestibular Schwannoma

NCT ID: NCT03079999

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2029-02-28

Brief 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.

Detailed Description

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. In the Randomized Treatment Phase, patients aged 12 years or older with VSs will be identified and recruited into one of two randomized groups who receive either 1) 325 mg aspirin twice daily (81 mg aspirin twice daily for pediatric patients <50 kg); or 2) a placebo. Patients will stay on aspirin/placebo as long as there is no more than 20% increase in VS volume. At tumor progression, patients will enter the Open Label Follow Up Phase. Patients who progress on placebo will be given the option to receive unblinded aspirin and will be followed until further progression, receiving a definitive treatment (e.g, surgery or radiation), or 42 months post-baseline, whichever occurs first. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed until they receive a definitive treatment (e.g., surgery or radiation) or reach 42 months post-baseline, whichever comes first.

Conditions

Vestibular Schwannoma; Acoustic Neuroma; Neurofibromatosis 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aspirin

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 Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Twice daily aspirin

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Twice daily placebo

Interventions

Aspirin

Twice daily aspirin

Intervention Type: DRUG

Placebo

Twice daily placebo

Intervention Type: DRUG

Other Intervention Names

Zoprin; Durlaza; Bayer

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

D. Bradley Welling, MD, PhD

Walter Augustus Lecompte Distinguished Professor Harvard Department of Otolaryngology-Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantina Stankovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

D. Bradley Welling, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear

Locations

Stanford Otolaryngology/HNS

Stanford, California, United States

University of Miami

Miami, Florida, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

17-030

Identifier Type: -

Identifier Source: org_study_id

W81XWH-17-1-0644

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id