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

NCT ID: NCT00070161

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-01
• Study Completion Date: 2012-08-01

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.

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)

Conditions

Brain and Central Nervous System Tumors; Radiation Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Interventions

cognitive assessment

Intervention Type: PROCEDURE

EGb761

Intervention Type: DIETARY_SUPPLEMENT

donepezil hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward G. Shaw, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

CCOP - Western Regional, Arizona

Phoenix, Arizona, United States

Regional Radiation Oncology Center at Rome

Rome, Georgia, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Countries

United States

References

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. doi: 10.1200/JCO.2005.03.3001.

Reference Type: RESULT

PMID: 16549835 (View on PubMed)

Other Identifiers

U10CA081851

Identifier Type: NIH

Identifier Source: secondary_id

View Link

REBACCCWFU-97100

Identifier Type: -

Identifier Source: org_study_id