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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00070161

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

133

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Radiation Toxicity	Dietary Supplement: EGb761 Drug: donepezil hydrochloride Procedure: cognitive assessment	Phase 2

Detailed Description

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2001

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

Aug 1, 2012

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
2	Regional Radiation Oncology Center at Rome	Rome	Georgia	United States	30165
3	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1030
4	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303