Study of Aspirin in Patients With Vestibular Schwannoma

Vestibular Schwannoma Clinical Trial

Official title:

Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03079999
• Other study ID #: 17-030
• Status: Recruiting
• Phase: Phase 2
• Start date: June 11, 2018
• Est. completion date: February 2029

Study information

• Verified date: December 2023
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Odeta Dyrmishi
• Phone: 617-573-6060
• Email: odeta_dyrmishi[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2029
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acoustic Neuroma
• Neurilemmoma
• Neurofibromatoses
• Neurofibromatosis 2
• Neuroma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Drug:
• Aspirin
Twice daily aspirin
• Placebo
Twice daily placebo

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear	Boston	Massachusetts
United States	University of Iowa	Iowa City	Iowa
United States	University of Miami	Miami	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Stanford Otolaryngology/HNS	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	Massachusetts General Hospital, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	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