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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU-91305 | Other Identifier | Comprehensive Cancer Center of WFUHS | |
| CCCWFU-IRB-00000258 | Other Identifier | WFUHS IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donepozil | Experimental | Donepezil 5 milligrams a day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil | Drug | Donepezil 5 milligrams a day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks | Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon M. Castellino, MD, FAAP | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts-NEMC Cancer Center | Boston | Massachusetts | 02111 | United States | ||
| Wake Forest University Comprehensive Cancer Center |
13 unique patients were recruited, one patient twice after failing to start therapy the first time, two patients were not evaluable, leaving 11 patients for analysis.
patients were registered from 9/11/2006 to 5/14/2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil | Patients less than 35 kilograms(kg): Donepezil 5 milligrams (mg) orally once every alternate day. Patients greater than 35 kg Donepezil 5 mg orally once per day. If there are no adverse effects noted on review of symptoms, the dose will be increased to 5 mg daily for patients < 35 kg. And to 10 mg/day for patients > 35 kg. This evaluation and dose escalation may be done as early as week 4. For all, donepezil will be administered 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Winston-Salem |
| North Carolina |
| 27157-1096 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks | Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome. | Posted | Mean | Standard Deviation | units on a scale | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil | 3 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
| |
| Dehydration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ataxia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence, urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Personality/behavioral | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Occular/Visual | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever (in the absence of neutropenia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Speech Impairment | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood Alteration: Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Abdomen NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Back | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhag, pulmonary/upper respiratory: nose | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontenence, anal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized: whole body | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain: Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain: Extremity-limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC: Bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC: Nerv-peripheral | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC: Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalid or specfic ara (not due to neuropathy): Left sided | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: cranial: CN VIII Hearing and balance | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
small number (11) analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janet Tooze | Wake Forest Baptist Health | 336-716-0286 | jtooze@wakehealth.edu |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| D011832 | Radiation Injuries |
| D016545 | Choroid Plexus Neoplasms |
| D013120 | Spinal Cord Neoplasms |
| D008527 | Medulloblastoma |
| D020339 | Optic Nerve Glioma |
| D001254 | Astrocytoma |
| C531673 | Familial ependymoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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