Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Donepezil or EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Completed 18 and over NCI CCCWFU-97100 CCCWFU-BG00-225, NCT00070161

Objectives

Primary

1. 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

1. Determine the toxicity of these drugs in these patients.
2. Determine the quality of life of patients treated with these drugs.
3. Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs.

Entry 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

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

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

Expected Enrollment

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)

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.

Shaw EG, Rosdhal R, D'Agostino RB Jr, et al.: Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. J Clin Oncol 24 (9): 1415-20, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Edward Shaw, MD, Protocol chair		Ph: 336-713-6506; 800-446-2255 Email: eshaw@wfubmc.edu

Registry Information
Official Title		Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients
Trial Start Date		2004-03-31
Registered in ClinicalTrials.gov		NCT00070161
Date Submitted to PDQ		2003-08-15
Information Last Verified		2006-01-18
NCI Grant/Contract Number		CA12197