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

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00070161

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors Radiation Toxicity	Dietary Supplement: EGb761 Drug: donepezil hydrochloride Procedure: cognitive assessment	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: E 2020 Donepezil EGB 761

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Study Start Date:

March 2004

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070161

Locations

United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, Georgia
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Edward G. Shaw, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00070161 History of Changes
Other Study ID Numbers:	CDR0000330114, CCCWFU-97100, CCCWFU-BG00-225
Study First Received:	October 3, 2003
Last Updated:	August 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by Wake Forest University Baptist Medical Center:

radiation toxicity
adult mixed glioma
adult central nervous system germ cell tumor
adult brain stem glioma
adult craniopharyngioma
adult medulloblastoma
adult meningioma
adult choroid plexus tumor
adult tumors metastatic to brain
adult anaplastic oligodendroglioma
adult anaplastic astrocytoma
adult pilocytic astrocytoma
adult subependymoma

adult meningeal hemangiopericytoma
adult ependymoblastoma
adult anaplastic ependymoma
adult pineoblastoma
adult pineocytoma
adult myxopapillary ependymoma
adult glioblastoma
adult grade III meningioma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
adult ependymoma

Additional relevant MeSH terms:

Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries
Donepezil

Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012