Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Active	8 to 17	NCI	CCCWFU-91305 CCCWFU-IRB-00000258, CCCWFU 91305, NCT00452868

Objectives

Primary

1. Determine the impact of donepezil hydrochloride on cognitive function in pediatric patients with primary brain tumors previously treated with cranial radiotherapy.

Secondary

1. Assess health-related quality of life of patients treated with this drug.
2. Assess function and quality of life of the families of patients treated with this drug.
3. Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in patients treated with this drug.
4. Determine the toxicity of donepezil hydrochloride in these patients.

Entry Criteria

Disease Characteristics:

• Prior diagnosis of primary brain tumor
• No type 2 neurofibromatosis
• Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
  • No stereotactic radiosurgery as sole treatment
• No evidence of disease progression by MRI

Prior/Concurrent Therapy:

• See Disease Characteristics
• More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug
• No steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
• No other concurrent anticholinergic drugs

Patient Characteristics:

• Karnofsky or Lansky performance status 70-100%
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3
• Stable weight within the past 6 months with no concern of weight loss
• Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated
• Able to speak English
• No attention-deficit/hyperactivity disorder before cancer diagnosis
• No uncontrolled seizures or uncontrolled endocrinopathies
• No uncontrolled comorbidities

Expected Enrollment

A total of 35 patients will be accrued for this study.

Outcomes

Effect of donepezil hydrochloride on neurocognitive function as measured by the neurocognitive battery at 24 weeks

Comparison of baseline dynamic vascular analysis (DVA™) indices in pediatric patients who score < 70 vs pediatric patients who score > 70 on the Peabody Picture Vocabulary Test-3
Correlation of changes in DVA™ indices with changes in cognitive function
Health-related quality of life (QOL) as measured by Child Report of QOL and Pediatric QOL Inventory (parent and child components) at baseline and at 12, 24, and 36 weeks
Family impact as measured by Life Events, Pediatric Inventory for Parents, and Impact on Family at week 24
Toxicity as measured by NCI CTCAE v3.0
Barriers to recruitment and retention of pediatric 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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Sharon Castellino, MD, FAAP, Protocol chair		Ph: 336-716-4085; 800-446-2255 Email: scastell@wfubmc.edu

U.S.A.
Massachusetts
	Boston
	Tufts-NEMC Cancer Center
		Susan Parsons, MD, MRP	Ph:  617-636-6212
			Email: SParsons@tuftsmedicalcenter.org
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771

Registry Information
Official Title		A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
Trial Start Date		2006-06-26
Registered in ClinicalTrials.gov		NCT00452868
Date Submitted to PDQ		2007-02-15
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA12197

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