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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070161 |
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 |
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Brain and Central Nervous System Tumors Cancer-Related Problem/Condition |
Drug: EGb761 Drug: donepezil hydrochloride Procedure: cognitive assessment |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
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)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary brain tumor or brain metastases, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study Chair: | Edward G. Shaw, MD | Wake Forest University |
Study ID Numbers: | CDR0000330114, CCCWFU-97100, CCCWFU-BG00-225 |
Study First Received: | October 3, 2003 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00070161 |
Health Authority: | United States: Federal Government |
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 |
Choroid Plexus Neoplasms Glioblastoma Astrocytoma Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Hemangiopericytoma Ependymoma Brain Neoplasms Donepezil |
Craniopharyngioma Neoplasm Metastasis Medulloblastoma Oligodendroglioma Meningioma Glioma Choroid Plexus neoplasms Gliosarcoma Pinealoma Nervous System Neoplasms |
Nootropic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Cholinergic Agents |
Pharmacologic Actions Cholinesterase Inhibitors Neoplasms Neoplasms by Site Therapeutic Uses Central Nervous System Agents |