Study of Aspirin in Patients With Vestibular Schwannoma

December 13, 2023 updated by: D. Bradley Welling, MD, PhD, Massachusetts Eye and Ear Infirmary

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford Otolaryngology/HNS
        • Principal Investigator:
          • Konstantina Stankovic, MD, PhD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Alexander Claussen, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Brian Neff, MD
    • Utah
      • Salt Lake City, Utah, United States, 84101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Twice daily aspirin
Other Names:
  • Bayer
  • Zoprin
  • Durlaza
Placebo Comparator: Placebo
Patients on the placebo arm will receive blinded placebo and take it twice a day.
Twice daily placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Progression, or around 3.5 years
Progression Free Survival (PFS) is the length of time from start of study treatment to tumor growth of more than 20%.
Progression, or around 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Konstantina Stankovic, MD, PhD, Stanford University
  • Principal Investigator: D. Bradley Welling, MD, PhD, Massachusetts Eye and Ear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2018

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurofibromatosis 2

Clinical Trials on Aspirin

3
Subscribe