Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
Completed · Early Phase 1
Conditions studied: Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity
In brief
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.
Key facts
- Study ID
- NCT00452868
- Run by
- Wake Forest University Health Sciences
- People needed
- 14
- Starts
- 2006-06-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2018-09-07
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tufts-NEMC Cancer Center — Boston, Massachusetts, United States
- Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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