A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
- Determine the impact of donepezil hydrochloride on cognitive function in pediatric
patients with primary brain tumors previously treated with cranial radiotherapy.
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
Sharon M. Castellino, MD, FAAP
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Tufts-NEMC Cancer Center||Boston, Massachusetts 02111|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|