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 : July 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Schwannoma Acoustic Neuroma Neurofibromatosis 2||Drug: Aspirin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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)|
|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 :||February 2021|
|Estimated Study Completion Date :||February 2022|
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
Placebo Comparator: Placebo
Patients on the placebo arm will receive blinded placebo and take it twice a day.
Twice daily placebo
- 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%.
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
|Contact: Amy Quinkert, PhD||617-573-4192||Amy_Quinkert@meei.harvard.edu|
|Contact: Konstantina Stankovic, MD, PhD||617-573-3972||Konstantina_Stankovic@meei.harvard.edu|
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Amy Quinkert, PhD 617-573-4192 email@example.com|
|Principal Investigator:||Konstantina Stankovic, MD, PhD||Massachusetts Eye and Ear Infirmary|