NCT00452868

Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain and Central Nervous System Tumors
• Cognitive/Functional Effects
• Long-term Effects Secondary to Cancer Therapy in Children
• Neurotoxicity
• Psychosocial Effects of Cancer and Its Treatment
• Radiation Toxicity

Interventions

Type	Name	Description
DRUG	Donepezil	Donepezil 5 milligrams a day for 6 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-03-28
• Last updated: 2018-09-07
• Results posted: 2013-02-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study