Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Brain Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 8/15/2018 |
| Start Date: | July 2001 |
| End Date: | August 2012 |
Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
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.
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.
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)
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)
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
We found this trial at
4
sites
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Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2255
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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