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NCT00452868 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
EARLY PHASE1
Status at capture
COMPLETED
Registry last update
2018-09-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
17 Years
minimum Age
8 Years
sex
ALL
std Ages
  1. CHILD
Treatment arms and interventions
arm Groups
  1. description
    Donepezil 5 milligrams a day for 6 weeks
    intervention Names
    1. Drug: Donepezil
    label
    Donepozil
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Donepozil
    description
    Donepezil 5 milligrams a day for 6 weeks
    name
    Donepezil
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
14
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
    measure
    Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
    time Frame
    24 weeks
Full study description
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 brain tumors previously treated with radiation therapy to the brain.
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 * 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.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
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    Preserved source evidence · Not medical advice