- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079999
Study of Aspirin in Patients With Vestibular Schwannoma
December 13, 2023 updated by: D. Bradley Welling, MD, PhD, Massachusetts Eye and Ear Infirmary
Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Odeta Dyrmishi
- Phone Number: 617-573-6060
- Email: odeta_dyrmishi@meei.harvard.edu
Study Contact Backup
- Name: D. Bradley Welling, MD, PhD
- Phone Number: 617-573-3632
- Email: Brad_Welling@MEEI.HARVARD.EDU
Study Locations
-
-
California
-
Stanford, California, United States, 94304
- Recruiting
- Stanford Otolaryngology/HNS
-
Principal Investigator:
- Konstantina Stankovic, MD, PhD
-
Contact:
- Leeza Kopaeva
- Email: lkopaeva@stanford.edu
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Constanza Pelusso
- Email: CPelusso@med.miami.edu
-
Principal Investigator:
- Fred Telischi, MD
-
Contact:
- Ivanna Fernandez
- Email: ixf232@med.miami.edu
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
-
Contact:
- Judith Leon
- Email: judith-leon@uiowa.edu
-
Principal Investigator:
- Alexander Claussen, MD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts Eye and Ear
-
Contact:
- Bradley Welling, MD, PhD
- Phone Number: 617-573-3632
- Email: Brad_Welling@MEEI.HARVARD.EDU
-
Principal Investigator:
- D. Bradley Welling, MD
-
Contact:
- Odeta Dyrmishi
- Phone Number: 617-573-6060
- Email: odeta_dyrmishi@meei.harvard.edu
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Contact:
- Amy Tuchscherer, CCRC
- Phone Number: 507-538-6582
- Email: Tuchscherer.Amy@mayo.edu
-
Principal Investigator:
- Brian Neff, MD
-
-
Utah
-
Salt Lake City, Utah, United States, 84101
- Recruiting
- University of Utah
-
Principal Investigator:
- Neil Patel, MD
-
Principal Investigator:
- Richard Gurgel, MD
-
Contact:
- Victoria Gonce
- Email: victoria.gonce@hsc.utah.edu
-
Contact:
- Grace Johnson
- Email: grace.johnson@hsc.utah.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
Twice daily aspirin
Other Names:
|
Placebo Comparator: Placebo
Patients on the placebo arm will receive blinded placebo and take it twice a day.
|
Twice daily placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
Progression, or around 3.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Konstantina Stankovic, MD, PhD, Stanford University
- Principal Investigator: D. Bradley Welling, MD, PhD, Massachusetts Eye and Ear
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2018
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
February 1, 2029
Study Registration Dates
First Submitted
March 6, 2017
First Submitted That Met QC Criteria
March 9, 2017
First Posted (Actual)
March 15, 2017
Study Record Updates
Last Update Posted (Actual)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Genetic Diseases, Inborn
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neurodegenerative Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Ear Diseases
- Nervous System Neoplasms
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Nerve Sheath Neoplasms
- Neurocutaneous Syndromes
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Neurofibroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Neurofibromatoses
- Neuroma
- Neurofibromatosis 2
- Neurilemmoma
- Neuroma, Acoustic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 17-030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurofibromatosis 2
-
NYU Langone HealthNovartis Pharmaceuticals; The Children's Tumor FoundationCompletedNeurofibromatosis Type IIUnited States
-
Massachusetts Eye and Ear InfirmaryRecruiting
-
National Institute of Neurological Disorders and...Recruiting
-
Manchester University NHS Foundation TrustCompletedNeurofibromatosis Type 2United Kingdom
-
PTC TherapeuticsUnited States Department of DefenseTerminated
-
Recursion Pharmaceuticals Inc.RecruitingNeurofibromatosis Type 2United States
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsTerminatedNeuroma, Acoustic | Neurofibromatosis Type 2United States
-
NYU Langone HealthCompletedNeurofibromatosis Type 2 | Vestibular SchwannomasUnited States
-
Li PengBetta Pharmaceuticals Co., Ltd.CompletedNeurofibromatosis Type 2 | Vestibular SchwannomaChina
-
National Cancer Institute (NCI)CompletedNeurofibromatosis Type 2 | Vestibular SchwannomaUnited States
Clinical Trials on Aspirin
-
The First Affiliated Hospital with Nanjing Medical...UnknownCoronary AtherosclerosisChina
-
Seoul National University HospitalCKD Pharmaceutical LimitedCompleted
-
Queen Mary University of LondonCancer Research UK; Barts and the London School of Medicine and DentistryCompletedProstate CancerUnited Kingdom
-
FANG HERecruitingPreeclampsia | Perinatal HaemorrhageChina
-
University of VigoRecruiting
-
Seoul National University HospitalCompletedCoronary Artery DiseaseKorea, Republic of
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPulmonary Disease, Chronic ObstructiveUnited States
-
Seoul National University HospitalCompletedHealthyKorea, Republic of
-
PLx PharmaCompletedDiabetes Mellitus, Type 2United States
-
Boehringer IngelheimCompletedCoronary ArteriosclerosisIreland