Study of Aspirin in Patients With Vestibular Schwannoma

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Study of Aspirin in Patients With Vestibular Schwannoma

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03079999
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts Eye and Ear Infirmary
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Konstantina Stankovic, MD, PhDD. Bradley Welling, MD, PhD
Principal Investigator Affiliation	Stanford UniversityMassachusetts Eye and Ear
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Vestibular Schwannoma, Acoustic Neuroma, Neurofibromatosis 2

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Drug: - Aspirin

Twice daily aspirin

Drug: - Placebo

Twice daily placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford Otolaryngology/HNS, Stanford, California

Status

Recruiting

Address

Stanford Otolaryngology/HNS

Stanford, California, 94304

Site Contact

Leeza Kopaeva

[email protected]

617-573-6060

University of Miami, Miami, Florida

Status