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View Clinical Trial (Medical Research Study)
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Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors - NCT00369785-29303 (Clinical Trial 148021)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy148021.aspx
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| City: |
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Spartanburg |
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State:
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SC |
| Zip Code: |
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29303 |
| Conditions: |
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Brain and Central Nervous System Tumors - Cognitive/Functional Effects - Fatigue - Metastatic Cancer - Psychosocial Effects of Cancer and Its Treatment - Radiation Toxicity |
| Purpose: |
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RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of
life in patients who have undergone radiation therapy for brain tumors. It is not yet known
whether donepezil is more effective than a placebo in lessening side effects of radiation
therapy in patients with brain tumors.
PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in
lessening side effects of radiation therapy compared with a placebo in patients who have
undergone radiation therapy for brain tumors.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare the effect of donepezil hydrochloride vs placebo, in terms of improving
neurocognitive symptom cluster (i.e., cognitive impairment, subjective confusion, and
fatigue), in patients who have undergone partial- or whole-brain irradiation for brain
tumors.
Secondary
- Compare the effect of these regimens on mood and quality of life in these patients.
OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized, multicenter
study. Patients are stratified according to prior brain irradiation type (whole-brain vs
partial-brain) and study site. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral donepezil hydrochloride once or twice daily for up to 24
weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once or twice daily for up to 24 weeks in the
absence of unacceptable toxicity.
Patients complete self-reported questionnaires (quality of life, fatigue, subjective
confusion, neurocognitive battery, and mood) at baseline and 12 and 24 weeks.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of primary or metastatic brain tumor
- Completed a course of ≥ 30 Gy fractionated whole-brain irradiation or large-field
partial-brain irradiation for primary or metastatic brain tumor ≥ 6 months prior to
study entry
- Meets the following criteria:
- Single-fraction stereotactic radiosurgery as a boost after external-beam
radiotherapy
- No polifeprosan 20 with carmustine implant (Gliadel wafers), GliaSite®, or
other type of brain brachytherapy
- No convection-enhanced delivery of immunotoxins
- No other investigational modalities as adjuvant therapy after external-beam
radiotherapy
- Must have treatment records (total dose, dose per fraction, and isodose curves)
available for all prior radiotherapy (external-beam radiotherapy, brachytherapy,
and/or stereotactic radiosurgery)
- Patients receiving prophylactic cranial irradiation are eligible
- No radiographic evidence of brain disease OR stable brain disease, defined as no
evidence of tumor progression within the past 3 months
- No brain metastases with progressive extracranial primary or metastatic disease
- Extracranial primary or metastatic disease must be stable or have responded to
local and/or systemic treatment within the past 3 months
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 30 weeks
- Karnofsky performance status 60-100%
- Patients must have a phone
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No sick sinus syndrome or supraventricular arrhythmias
- No hypersensitivity to donepezil hydrochloride
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior and no other concurrent dementia drugs, cognitive
enhancers, neuroleptics, and/or anti-parkinsonian agents
- Concurrent steroids, anti-cholinergics, anti-epileptics, anti-depressants, and/or
sedatives/benzodiazepines allowed provided patient is on a stable or decreasing dose
- Concurrent narcotic analgesics allowed provided the patient is on a stable dose
and/or prn basis
- No other planned therapy, including surgery, brain irradiation of any type,
chemotherapy, or immunotherapy, for the next 30 weeks for brain or extracranial
primary metastatic disease
- Concurrent trastuzumab (Herceptin®) for breast cancer allowed
- Concurrent hormonal therapy for breast or prostate cancer allowed
- No concurrent bethanechol, ketoconazole, quinidine, or succinylcholine
- No prior GliaSite or other type of brain brachytherapy, convection enhanced delivery
of immunotoxins, and/or any other investigational modalities for treatment of brain
tumor
- Gliadel wafers allowed
- No concurrent chemotherapy |
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| Study is available at: |
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CCOP - Upstate Carolina
Spartanburg, SC 29303
United States
Primary Contact:
Clinical Trials Office - CCOP - Upstate Carolina
Phone: 800-486-5941 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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