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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Donepezil

Criteria

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