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Study of Aspirin in Patients With Vestibular Schwannoma

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ClinicalTrials.gov Identifier: NCT03079999
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
United States Department of Defense
Massachusetts General Hospital
Information provided by (Responsible Party):
Konstantina Stankovic, Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE June 11, 2018
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
Progression Free Survival [ Time Frame: 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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03079999 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Aspirin in Patients With Vestibular Schwannoma
Official Title  ICMJE Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Schwannoma
  • Acoustic Neuroma
  • Neurofibromatosis 2
Intervention  ICMJE
  • Drug: Aspirin
    Twice daily aspirin
  • Drug: Placebo
    Twice daily placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Aspirin
  • Placebo Comparator: Placebo
    Patients on the placebo arm will receive blinded placebo and take it twice a day.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Grimm 617-573-6981 Elizabeth_Grimm@meei.harvard.edu
Contact: Konstantina Stankovic, MD, PhD 617-573-3972 Konstantina_Stankovic@meei.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03079999
Other Study ID Numbers  ICMJE 17-030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Konstantina Stankovic, Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE
  • United States Department of Defense
  • Massachusetts General Hospital
Investigators  ICMJE
Principal Investigator: Konstantina Stankovic, MD, PhD Massachusetts Eye and Ear Infirmary
Principal Investigator: D. Bradley Welling, MD, PhD Massachusetts Eye and Ear Infirmary
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP