Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor - Full Text View

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Brain Tumors

Drug Information available for: Donepezil hydrochloride Donepezil

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Ependymoma Oligodendroglioma Anaplastic Oligodendroglioma Craniopharyngioma Gliosarcoma Meningioma Anaplastic Astrocytoma Hemangiopericytoma Medulloblastoma Embryonal Tumor With Multilayered Rosettes Anaplastic Ependymoma Pineoblastoma Pineocytoma Pilocytic Astrocytoma Subependymoma Myxopapillary Ependymoma

U.S. FDA Resources

Further study details as provided by Wake Forest University Health Sciences:


Enrollment:	68
Study Start Date:	July 2001
Study Completion Date:	August 2012
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

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 to 120 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Health Sciences

National Cancer Institute (NCI)

Investigators


Study Chair:	Edward G. Shaw, MD	Wake Forest University Health Sciences

More Information

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.


Responsible Party:	Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT00070161 History of Changes
Other Study ID Numbers:	REBACCCWFU-97100 U10CA081851 ( US NIH Grant/Contract Award Number )
Study First Received:	October 3, 2003
Last Updated:	January 17, 2017
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by Wake Forest University Health Sciences:


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 Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents

ClinicalTrials.gov processed this record on May 25, 2017