Status:
COMPLETED
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Eligibility:
All Genders
8-17 years
Phase:
EARLY_PHASE1
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00452868
Start Date
June 1 2006
End Date
February 1 2010
Last Update
September 7 2018
Active Locations (2)
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1
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
2
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096