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Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
This study has been completed.
Sponsor:
Wake Forest University Health Sciences
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00070161
First received: October 3, 2003
Last updated: May 25, 2017
Last verified: November 2016
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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 (masked roles unspecified) 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
Genetic and Rare Diseases Information Center resources:
Glioblastoma
Craniopharyngioma
Anaplastic Astrocytoma
Ependymoma
Glioma
Medulloblastoma
Gliosarcoma
Meningioma
Oligodendroglioma
Anaplastic Oligodendroglioma
Hemangiopericytoma
Anaplastic Ependymoma
Pineoblastoma
Embryonal Tumor With Multilayered Rosettes
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) |
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
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:
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00070161 History of Changes |
| Other Study ID Numbers: |
REBACCCWFU-97100 U10CA081851 ( U.S. NIH Grant/Contract ) |
| Study First Received: | October 3, 2003 |
| Last Updated: | May 25, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | 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 July 21, 2017