Study of Aspirin in Patients with Vestibular Schwannoma

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.

Conditions

Vestibular Schwannoma, Acoustic Neuroma, Neurofibromatosis 2

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Study Overview

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Study Details

Study overview

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.

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

Study of Aspirin in Patients with Vestibular Schwannoma

Condition
Vestibular Schwannoma
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford Otolaryngology/HNS, Stanford, California, United States, 94304

Miami

University of Miami, Miami, Florida, United States, 33136

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Boston

Massachusetts Eye and Ear, Boston, Massachusetts, United States, 02114

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts Eye and Ear Infirmary,

Konstantina Stankovic, MD, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

D. Bradley Welling, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

2029-02