Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-29 @ 5:14 PM
Study NCT ID:
NCT00452868
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2007-03-27
Is Gene Therapy:
True
Has Adverse Events:
True
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:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |
| CCCWFU-91305 | OTHER | Comprehensive Cancer Center of WFUHS | View | |
| CCCWFU-IRB-00000258 | OTHER | WFUHS IRB | View |