Official Title: “Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients”

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.

Study Type: Interventional

Study Design: Supportive Care, Open Label

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)

Intervention(s) in this Clinical Trial

• Drug: EGb761
• Drug: donepezil hydrochloride
• Procedure: cognitive assessment

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wake Forest University

Overall Clinical Trial Officials and Contacts

Edward G. Shaw, MD Study Chair Wake Forest University  

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00070161

Study ID Number: CDR0000330114

ClinicalTrials.gov Identifier: NCT00070161

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database