Study of Aspirin in Patients With Vestibular Schwannoma

Trial ID or NCT#

NCT03079999

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Konstantina M. Stankovic, MD, PhD, FACS
Konstantina M. Stankovic, MD, PhD, FACS
Otology and neurotology specialist, Ear, nose, and throat specialist, Medical Otologist
Bertarelli Foundation Professor and Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Neurosurgery

Contact us to find out if this trial is right for you.

Contact

Homer Abaya
650-723-7697

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View on ClinicalTrials.gov