Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

Study Overview
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Brief Summary
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RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such as thinking, attention, concentration, and memory) and may improve quality of life in patients who have undergone radiation therapy to the brain. PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.

Detailed Description
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OBJECTIVES: Primary Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration. Secondary Determine the toxicity of these drugs in these patients. Determine the quality of life of patients treated with these drugs. Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs. OUTLINE: This is an open-label, multicenter study. Group 1 (closed to accrual 10/09/03): Patients receive oral donepezil once daily for 24 weeks. Group 2: Patients receive oral EGb761 three times daily for 24 weeks. In both groups (group 1 closed to accrual 10/09/03), treatment continues in the absence of unacceptable toxicity. In both groups (group 1 closed to accrual 10/09/03), quality of life and neurocognitive assessment is performed at baseline and at weeks 6 (group 1 only), 12, 24, and 30. Patients are followed at 6 weeks. PROJECTED ACCRUAL: A total of 70 patients (35 per treatment group) will be accrued for this study within 9.5 months. (Group 1 closed to accrual 10/09/03)

Official Title
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Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases

Conditions
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Brain and Central Nervous System Tumors, Radiation Toxicity

Intervention / Treatment
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* Dietary Supplement: EGb761
* Drug: donepezil hydrochloride
* Procedure: cognitive assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of primary brain tumor or brain metastases, meeting 1 of the following criteria: No radiographic evidence of disease Stable disease, defined as no tumor progression within the past 3 months Previously treated with 1 course of localized or whole brain radiotherapy of at least 3,000 cGy at least 6 months before study registration PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy At least 30 weeks Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No concurrent chemotherapy Endocrine therapy Concurrent steroid therapy allowed if on stable or decreasing dose Radiotherapy See Disease Characteristics No concurrent cranial radiotherapy Surgery No concurrent surgery Other More than 3 months since prior donepezil or EGb761 No concurrent donepezil (group 2 only) No concurrent EGb761 (group 1 only) (closed to accrual 10/09/03) No concurrent anticoagulants (e.g., aspirin, dipyridamole, heparin, warfarin, or enoxaparin) (group 2 only) No concurrent monoamine oxidase inhibitors (e.g., phenelzine or tranylcypromine) No other concurrent therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: EGb761|nan|
|Drug: donepezil hydrochloride|nan|
|Procedure: cognitive assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation toxicity, adult mixed glioma, adult central nervous system germ cell tumor, adult brain stem glioma, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult choroid plexus tumor, adult tumors metastatic to brain, adult anaplastic oligodendroglioma, adult anaplastic astrocytoma, adult pilocytic astrocytoma, adult subependymoma, adult meningeal hemangiopericytoma, adult ependymoblastoma, adult anaplastic ependymoma, adult pineoblastoma, adult pineocytoma, adult myxopapillary ependymoma, adult glioblastoma, adult grade III meningioma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult ependymoma