Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452868
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2007-03-27
Brief Title:
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
Status:
COMPLETED
Status Verified Date:
2018-08
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:
RATIONALE Donepezil may decrease the side effects caused by radiation therapy to the brain
PURPOSE This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain
PURPOSE This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain
Detailed Description:
OBJECTIVES
Primary
Determine the impact of donepezil hydrochloride on cognitive function in pediatric patients with primary brain tumors previously treated with cranial radiotherapy
Secondary
Assess health-related quality of life of patients treated with this drug
Assess function and quality of life of the families of patients treated with this drug
Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in patients treated with this drug
Determine the toxicity of donepezil hydrochloride in these patients
OUTLINE This is a multicenter pilot open-label controlled study
Patients receive oral donepezil hydrochloride once daily or once every other day for up to 24 weeks in the absence of disease progression or unacceptable toxicity After completion of 6 weeks of study therapy patients are evaluated for toxicity Patients experiencing no adverse effects from treatment may continue receiving donepezil hydrochloride at a higher dose for 18 more weeks
Patients undergo measurement of cognitive function by neurocognitive testing behavioral adjustment and social competency by parent-reported questionnaires health-related quality of life by child- and parent-reported questionnaires and vascular dynamics by transcranial Doppler ultrasound at baseline and at weeks 12 24 and 36 Family function and family quality of life are assessed at baseline and at week 24
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Determine the impact of donepezil hydrochloride on cognitive function in pediatric patients with primary brain tumors previously treated with cranial radiotherapy
Secondary
Assess health-related quality of life of patients treated with this drug
Assess function and quality of life of the families of patients treated with this drug
Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in patients treated with this drug
Determine the toxicity of donepezil hydrochloride in these patients
OUTLINE This is a multicenter pilot open-label controlled study
Patients receive oral donepezil hydrochloride once daily or once every other day for up to 24 weeks in the absence of disease progression or unacceptable toxicity After completion of 6 weeks of study therapy patients are evaluated for toxicity Patients experiencing no adverse effects from treatment may continue receiving donepezil hydrochloride at a higher dose for 18 more weeks
Patients undergo measurement of cognitive function by neurocognitive testing behavioral adjustment and social competency by parent-reported questionnaires health-related quality of life by child- and parent-reported questionnaires and vascular dynamics by transcranial Doppler ultrasound at baseline and at weeks 12 24 and 36 Family function and family quality of life are assessed at baseline and at week 24
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU-IRB-00000258 | OTHER | WFUHS IRB | httpsreporternihgovquickSearchP30CA012197 |
| P30CA012197 | NIH | None | None |
| CCCWFU-91305 | OTHER | None | None |