Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor (NCT00070161) | Clinical Trial Compass
CompletedPhase 2
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
United States68 participantsStarted 2001-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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