Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01345136
Status:
TERMINATED
Last Update Posted:
2024-02-13
First Post:
2011-04-21
Brief Title:
Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Single Arm Monocenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis Type 2 - Related Vestibular Schwannoma
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth of the vestibular schwannomas in Neurofibromatosis 2 NF2 patients Secondary objectives include determining if RAD001 treatment will improve hearing ability in NF2 patients
RAD001 is an oral drug that is approved by Food and Drug Administration FDA for other types of tumors it is not approved by the FDA for treatment of NF2 related tumors
RAD001 is an oral drug that is approved by Food and Drug Administration FDA for other types of tumors it is not approved by the FDA for treatment of NF2 related tumors
Detailed Description:
This protocol is a Phase II open-label efficacy and safety study of single-agent RAD001 in patients with NF2 During the study subjects will receive continuous daily oral treatment with RAD001 for up to 1 year or until tumor progression
Primary Objective To determine whether RAD001 has an effect on the VS growth in patients with NF2 at a rate sufficient to submit the drug for further testing
Secondary Objectives To determine whether RAD001 has an effect on the volume of other intracranial tumors and to assess the effect of RAD001 on hearing function in patients with NF2 when applicable
Primary Objective To determine whether RAD001 has an effect on the VS growth in patients with NF2 at a rate sufficient to submit the drug for further testing
Secondary Objectives To determine whether RAD001 has an effect on the volume of other intracranial tumors and to assess the effect of RAD001 on hearing function in patients with NF2 when applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None