Study of Aspirin in Patients with Vestibular Schwannoma

Phase 2

Recruiting

• Conditions: Vestibular Schwannoma; Acoustic Neuroma; Neurofibromatosis 2
• Interventions: Drug: Placebo; Drug: Aspirin

• Registration Number: NCT03079999
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief 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.

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 Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2018-06-11
• Status Verified: 2023-12
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-09
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients on the placebo arm will receive blinded placebo and take it twice a day.
Aspirin	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	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%.

Trial Locations

Locations (6)

Stanford Otolaryngology/HNS; 🇺🇸 Stanford, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States