Study of Aspirin in Patients With Vestibular Schwannoma

NCT03079999 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 17-030W81XWH-17-1-0644
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 5

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.

Conditions

Vestibular Schwannoma; Acoustic Neuroma; Neurofibromatosis 2

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression Free Survival (PFS) is the length of time from start of study treatment to tumor growth of more than 20%.

  Progression, or around 3.5 years

Study Arms (2)

Aspirin

EXPERIMENTAL

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.

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Aspirin DRUG

Twice daily aspirin

Also known as: Zoprin, Durlaza, Bayer

Aspirin

Placebo DRUG

Twice daily placebo

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to perform volumetric measurements of vestibular schwannoma(s).
• Inability to tolerate MRI with contrast.
• 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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• United States Department of Defense: collaborator

Study Sites (5)

Stanford Otolaryngology/HNS

Stanford, California, 94304, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Utah

Salt Lake City, Utah, 84101, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Neurofibromatosis 2

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Neurofibromatoses; Neurofibroma; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Konstantina Stankovic, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• D. Bradley Welling, MD, PhD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Walter Augustus Lecompte Distinguished Professor Harvard Department of Otolaryngology-Head and Neck Surgery

Model Details: 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 receive unblinded aspirin. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed. All patients will be followed for at least 3.5 years after randomization.

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 15, 2017
• Study Start: June 11, 2018
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)