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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00452868 |
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Date of registration:
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27/03/2007 |
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Primary sponsor: |
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Public title:
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Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
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Scientific title:
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A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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35 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00452868 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Sharon M. Castellino, MD, FAAP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Comprehensive Cancer Center of Wake Forest University |
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Key inclusion & exclusion criteria
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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
Age minimum:
8 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain and Central Nervous System Tumors
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Cognitive/Functional Effects
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Long-term Effects Secondary to Cancer Therapy in Children
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Neurotoxicity
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Psychosocial Effects of Cancer and Its Treatment
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Radiation Toxicity
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Intervention(s)
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Drug: donepezil hydrochloride
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Procedure: cognitive assessment
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Procedure: psychosocial assessment and care
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Procedure: quality-of-life assessment
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Procedure: ultrasound imaging
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Primary Outcome(s)
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Effect of donepezil hydrochloride on neurocognitive function as measured by the neurocognitive battery at 24 weeks
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Secondary Outcome(s)
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Barriers to recruitment and retention of pediatric patients
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Comparison of baseline dynamic vascular analysis (DVA™) indices in pediatric patients who score < 70 vs pediatric patients who score > 70 on the Peabody Picture Vocabulary Test-3
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Correlation of changes in DVA™ indices with changes in cognitive function
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Family impact as measured by Life Events, Pediatric Inventory for Parents, and Impact on Family at week 24
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Health-related quality of life (QOL) as measured by Child Report of QOL and Pediatric QOL Inventory (parent and child components) at baseline and at 12, 24, and 36 weeks
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Toxicity as measured by NCI CTCAE v3.0
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Secondary ID(s)
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CCCWFU-91305
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CCCWFU-IRB-00000258
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CDR0000537049
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P30CA012197
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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