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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070161
• Other study ID #: REBACCCWFU-97100
• Secondary ID: U10CA081851
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2001
• Est. completion date: August 1, 2012

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 1, 2012
• Est. primary completion date: May 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms
• Radiation Toxicity

Intervention

Dietary Supplement:
• EGb761

Drug:
• donepezil hydrochloride

Procedure:
• cognitive assessment

Locations

Country	Name	City	State
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Regional Radiation Oncology Center at Rome	Rome	Georgia
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shaw EG, Rosdhal R, D'Agostino RB Jr, Lovato J, Naughton MJ, Robbins ME, Rapp SR. Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. J Clin Oncol. 2006 Mar 20;24(9):1415-20. — View Citation