Study of Aspirin in Patients With Vestibular Schwannoma

Status:	Recruiting
Conditions:	Cancer, Other Indications, Neurology, Podiatry
Therapuetic Areas:	Neurology, Oncology, Orthopedics / Podiatry, Other
Healthy:	No
Age Range:	12 - Any
Updated:	1/13/2019
Start Date:	June 11, 2018
End Date:	February 2022
Contact:	Edina Shu
Email:	Edina_Shu@meei.harvard.edu
Phone:	617-573-6822

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

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.

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.

We found this trial at

sites

Massachusetts Eye & Ear Infirmary

243 Charles St
Boston, Massachusetts 02114

(617) 523-7900