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Brief Title: Study of Aspirin in Patients With Vestibular Schwannoma
Official Title: Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas
Study ID: NCT03079999
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.
Detailed 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. 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 be given the option to receive unblinded aspirin and will be followed until further progression, receiving a definitive treatment (e.g, surgery or radiation), or 42 months post-baseline, whichever occurs first. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed until they receive a definitive treatment (e.g., surgery or radiation) or reach 42 months post-baseline, whichever comes first.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford Otolaryngology/HNS, Stanford, California, United States
University of Miami, Miami, Florida, United States
University of Iowa, Iowa City, Iowa, United States
Massachusetts Eye and Ear, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
University of Utah, Salt Lake City, Utah, United States
Name: Konstantina Stankovic, MD, PhD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR
Name: D. Bradley Welling, MD, PhD
Affiliation: Massachusetts Eye and Ear
Role: PRINCIPAL_INVESTIGATOR