Study Of Treating Patients With Vestibular Schwannoma With Aspirin

Overview

About this study

The purpose of this study is to evaluate whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in  patients with vestibular schwannoma (VS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic). Patients should be newly diagnosed within the last two years or have a growing tumor. Tumor will be considered growing if it has shown ≥2mm increase in any dimension between scans at least 11 months apart.
  • Age ≥ 12 years of age.
  • 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). Please see technical specifications for MRI collection in section 7.3.1 below.
  • 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. More than 250 mg of aspirin in a single week time frame is considered exclusionary.
  • Chronic use of steroids or non-steroidal anti-inflammatory drugs (NSAIDs). Daily use of these drugs more than one week per month on average is considered chronic.
  • Chronic anticoagulation with agents such as Coumadin, Pradaxa, Xarelto, Apixaban, Eliquis, Plavix, Angiomax, Argatroban, Iprivask, Heparin, Lovenox, Fragmin, Innohep, Fraxiparine, Arixtra, etc.
  • Prior treatment for vestibular schwannoma as follows:
    • Radiation to target lesion. For patients with bilateral vestibular schwannomas of which only one has been irradiated, patients will be eligible if the tumor on the non-irradiated side is designated the target lesion;
    • Avastin (bevacizumab) within 60 days prior to enrollment. Patients who have more than 60 day washout period are eligible;
    • Surgical resection of target lesion within 6 months prior to enrollment. Patients with prior surgical resection of the target lesion must have a post-op scan that shows residual tumor in order to be eligible. For patients with bilateral vestibular schwannomas of which only one has been resected, patients will be eligible if the tumor on the non-resected side is designated the target lesion.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Brian Neff, M.D.

Open for enrollment

More information

Publications

Publications are currently not available
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CLS-20469363

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