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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452868
• Other study ID #: CDR0000537049
• Secondary ID: P30CA012197CCCWF
• Status: Completed
• Phase: Early Phase 1
• Start date: June 2006
• Est. completion date: February 2010

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

• Karnofsky or Lansky performance status 70-100%

• Fertile patients willing to 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

• More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug

Exclusion Criteria:

• Stereotactic radiosurgery as sole treatment

• Evidence of disease progression by MRI

• Pregnant or nursing

• Attention-deficit/hyperactivity disorder before cancer diagnosis

• Uncontrolled seizures or uncontrolled endocrinopathies

• Uncontrolled comorbidities

• Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)

• Use of concurrent anticholinergic drugs

Related Conditions & MeSH terms

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

Intervention

Drug:
• Donepezil
Donepezil 5 milligrams a day for 6 weeks

Locations

Country	Name	City	State
United States	Tufts-NEMC Cancer Center	Boston	Massachusetts
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks