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Study of Aspirin in Patients With Vestibular Schwannoma

Primary Purpose

Vestibular Schwannoma, Acoustic Neuroma, Neurofibromatosis 2

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Placebo
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Schwannoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Otolaryngology/HNSRecruiting
  • University of MiamiRecruiting
  • University of IowaRecruiting
  • Massachusetts Eye and Ear InfirmaryRecruiting
  • Mayo ClinicRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aspirin

Placebo

Arm Description

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.

Patients on the placebo arm will receive blinded placebo and take it twice a day.

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression Free Survival (PFS) is the length of time from start of study treatment to tumor growth of more than 20%.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2017
Last Updated
June 13, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
United States Department of Defense, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03079999
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
February 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
United States Department of Defense, Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma, Acoustic Neuroma, Neurofibromatosis 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients on the placebo arm will receive blinded placebo and take it twice a day.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Zoprin, Durlaza, Bayer
Intervention Description
Twice daily aspirin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Twice daily placebo
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression Free Survival (PFS) is the length of time from start of study treatment to tumor growth of more than 20%.
Time Frame
Progression, or around 3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Odeta Dyrmishi
Phone
617-573-6060
Email
odeta_dyrmishi@meei.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
D. Bradley Welling, MD, PhD
Phone
6175733632
Email
Brad_Welling@MEEI.HARVARD.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantina Stankovic, MD, PhD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
D. Bradley Welling, MD, PhD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Otolaryngology/HNS
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohan Reddy
Email
roreddy@stanford.edu
First Name & Middle Initial & Last Name & Degree
Konstantina Stankovic, MD, PhD
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constanza Pelusso
Email
CPelusso@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Ivanna Fernandez
Email
ixf232@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Fred Telischi, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Leon
Email
judith-leon@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Marlan Hansen, MD
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odeta Dyrmishi
Phone
617-573-6060
Email
odeta_dyrmishi@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Bradley Welling, MD, PhD
Phone
617-573-3632
Email
Brad_Welling@MEEI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
D. Bradley Welling, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Tuchscherer, CCRC
Phone
507-538-6582
Email
Tuchscherer.Amy@mayo.edu
First Name & Middle Initial & Last Name & Degree
Brian Neff, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Gonce
Email
victoria.gonce@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Grace Johnson
Email
grace.johnson@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Neil Patel, MD
First Name & Middle Initial & Last Name & Degree
Richard Gurgel, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Aspirin in Patients With Vestibular Schwannoma

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