Study of Aspirin in Patients With Vestibular Schwannoma

  • STATUS
    Recruiting
  • End date
    Feb 14, 2023
  • participants needed
    300
  • sponsor
    Massachusetts Eye and Ear Infirmary
Updated on 14 May 2021
aspirin
schwannoma
tumor growth
administration of aspirin

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.

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.

Details
Condition Neurofibromatosis, Acoustic Neuroma, Bilateral acoustic neurofibromatosis, neurofibromatosis type 2, neurofibromatosis type ii, type 2 neurofibromatosis, vestibular schwannoma
Treatment Placebo, Aspirin
Clinical Study IdentifierNCT03079999
SponsorMassachusetts Eye and Ear Infirmary
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic)
Age12 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
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