Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients
- 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.
- 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
- 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
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)
Masking: Open Label, Primary Purpose: Supportive Care
Edward G. Shaw, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|Regional Radiation Oncology Center at Rome||Rome, Georgia 30165|