Clinical trial NCT03079999: Study of Aspirin in Patients With Vestibular Schwannoma
Official title: Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Vestibular Schwannoma
Acoustic Neuroma
Neurofibromatosis 2
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 receive unblinded aspirin. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed. All patients will be followed for at least 3.5 years after randomization.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Progression, or around 3.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Otolaryngology/HNS
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Stanford University
name: Konstantina Stankovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts Eye and Ear
name: D. Bradley Welling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: