Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411619
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2006-12-12
Brief Title:
Everolimus RAD001 Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Everolimus RAD001Therapy of Giant Cell Astrocytomas in Patients With Tuberous Sclerosis Complex
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 evaluate the safety and potential side effects of everolimus an experimental drug on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor astrocytoma
The hypothesis is that the drug will cause the tumor size to decrease and may have beneficial activity separate from effects on tumors in patients
The hypothesis is that the drug will cause the tumor size to decrease and may have beneficial activity separate from effects on tumors in patients
Detailed Description:
Tuberous Sclerosis Complex TSCis a genetic disorder with a birth incidence of approximately one in six thousand Five to twenty percent of patients with TSC will develop astrocytoma a slowly progressive tumor They grow and cause damage to surrounding brain tissue blockage of spinal fluid hydrocephalus blindness trouble walking seizures and brain damage If untreated they can be fatal Standard treatment involves surgery to remove the tumor however surgery may itself cause brain damage bleeding or infection as well as other complications Studies have shown that everolimus suppresses the chemicals that cause tumors to grow in tuberous sclerosis and may cause them to shrink
The primary objective of this study is to find out the effects of everolimus on astrocytomas in a six month trial in patients with Tuberous Sclerosis who have been diagnosed with an astrocytoma
The primary objective of this study is to find out the effects of everolimus on astrocytomas in a six month trial in patients with Tuberous Sclerosis who have been diagnosed with an astrocytoma
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