Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas
Who is this study for? Child to adult patients with Vestibular Schwannoma
What treatments are being studied? Aspirin
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Stanford Otolaryngology/HNS
RECRUITING
Stanford
Florida
University of Miami
RECRUITING
Miami
Iowa
University of Iowa
RECRUITING
Iowa City
Massachusetts
Massachusetts Eye and Ear
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Odeta Dyrmishi
odeta_dyrmishi@meei.harvard.edu
617-573-6060
Backup
D. Bradley Welling, MD, PhD
Brad_Welling@MEEI.HARVARD.EDU
617-573-3632
Time Frame
Start Date: 2018-06-11
Estimated Completion Date: 2029-02
Participants
Target number of participants: 300
Treatments
Experimental: Aspirin
Patients on the experimental arm will receive blinded aspirin. Pediatric subjects who weigh less than 110 lbs will take 81mg aspirin twice a day. All other subjects will take 325mg aspirin twice a day.
Placebo_comparator: Placebo
Patients on the placebo arm will receive blinded placebo and take it twice a day.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Massachusetts Eye and Ear Infirmary