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Study of Aspirin in Patients With Vestibular Schwannoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079999
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
United States Department of Defense
Massachusetts General Hospital
Information provided by (Responsible Party):
D. Bradley Welling, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Acoustic Neuroma Neurofibromatosis 2 Drug: Aspirin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Official Title: Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : February 2023


Arm Intervention/treatment
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.
Drug: Aspirin
Twice daily aspirin
Other Names:
  • Zoprin
  • Durlaza
  • Bayer

Placebo Comparator: Placebo
Patients on the placebo arm will receive blinded placebo and take it twice a day.
Drug: Placebo
Twice daily placebo




Primary Outcome Measures :
  1. 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%.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079999


Contacts
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Contact: Alyssa Brown 617-573-3632 alyssa_brown@meei.harvard.edu
Contact: D. Bradley Welling, MD, PhD 6175733632 Brad_Welling@MEEI.HARVARD.EDU

Locations
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United States, California
Stanford Otolaryngology/HNS Recruiting
Stanford, California, United States, 94304
Contact: Homer Abaya    650-723-7697    habaya@stanford.edu   
Principal Investigator: Konstantina Stankovic, MD, PhD         
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Constanza Pelusso       CPelusso@med.miami.edu   
Principal Investigator: Fred Telischi, MD         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Diane Burke       diane-burke@uiowa.edu   
Principal Investigator: Marlan Hansen, MD         
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alyssa Brown       alyssa_brown@meei.harvard.edu   
Contact: Bradley Welling, MD, PhD    617-573-3632    Brad_Welling@MEEI.HARVARD.EDU   
Principal Investigator: D. Bradley Welling, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amy Tuchscherer, CCRC    507-538-6582    Tuchscherer.Amy@mayo.edu   
Principal Investigator: Brian Neff, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84101
Contact: Jordan Esplin       jordan.esplin@hsc.utah.edu   
Contact: Kimberly Gorton, CCRP       Kimberly.Gorton@hsc.utah.edu   
Principal Investigator: Neil Patel, MD         
Principal Investigator: Richard Gurgel, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
United States Department of Defense
Massachusetts General Hospital
Investigators
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Principal Investigator: Konstantina Stankovic, MD, PhD Massachusetts Eye and Ear Infirmary
Principal Investigator: D. Bradley Welling, MD, PhD Massachusetts Eye and Ear Infirmary
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Responsible Party: D. Bradley Welling, MD, PhD, Walter Augustus Lecompte Distinguished Professor Harvard Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03079999    
Other Study ID Numbers: 17-030
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neurofibromatoses
Neurilemmoma
Neuroma
Neuroma, Acoustic
Neurofibromatosis 2
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Cranial Nerve Neoplasms
Neoplasms by Site
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Aspirin