Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Completed	18 and over	NCI	CDR0000330114 CCCWFU-97100, CCCWFU-BG00-225, NCT00070161

Trial Description

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.

Further Study Information

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)

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Wake Forest University Baptist Medical Center

Edward G. Shaw

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00070161
Information obtained from ClinicalTrials.gov on September 16, 2009

Back to Top