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

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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
6
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Scott Plotkin, MD, PhD
Phone: 617-643-5495
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Marlan Hansen, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Clough Shelton, MD
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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243 Charles St
Boston, Massachusetts 02114
(617) 523-7900
Phone: 617-573-6822
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
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Boston, MA
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Rochester, Minnesota 55905
Principal Investigator: Brian Neff, MD
Phone: 507-538-6582
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Rochester, MN
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Stanford, California 94304
Principal Investigator: Robert Jackler, MD
Phone: 650-723-7697
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Stanford, CA
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