Clinical Trial: Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas

Brief Summary: The primary objective is to estimate the proportions of vestibular schwannomas (VS) and meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as determined by immunohistochemistry. This is a "phase 0" PK (pharmacokinetic) and PD (pharmacodynamic) study of RAD001 in patients with Neurofibromatosis Type 2-related and sporadic VS and meningiomas. Enrolled patients will take RAD001 prior to a scheduled VS or meningioma surgery, and blood and tissue samples will be obtained for further analysis.

Detailed Summary:
Sponsor: New York University School of Medicine

Current Primary Outcome: Proportions of VS and meningiomas after exposure to RAD001 [ Time Frame: 10 days ]

1) To estimate the proportions of VS and meningiomas with complete inhibition of phospho-S6 after10 days of exposure to RAD001 at a dose of 10 mg daily, as determined by immunohistochemistry. This endpoint was chosen based on prior pharmacodynamic data from a published trial, showing complete inhibition of phospho-S6 in solid tumor tissue of patients treated with RAD001 and our own preliminary data confirming baseline phospho-S6 expression in VS and meningiomas.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: New York University School of Medicine

Dates:
Date Received: June 11, 2013
Date Started: June 2013
Date Completion: December 2019
Last Updated: August 9, 2016
Last Verified: August 2016