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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Donepezil

Criteria

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