Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
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| ClinicalTrials.gov Identifier: NCT00070161 |
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Recruitment Status
:
Completed
First Posted
: October 7, 2003
Last Update Posted
: November 29, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors Radiation Toxicity | Dietary Supplement: EGb761 Drug: donepezil hydrochloride Procedure: cognitive assessment | Phase 2 |
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)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 68 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | July 2001 |
| Actual Primary Completion Date : | May 2005 |
| Actual Study Completion Date : | August 2012 |
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070161
| 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 Health Sciences |
Publications of Results:
| 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 ) |
| First Posted: | October 7, 2003 Key Record Dates |
| Last Update Posted: | November 29, 2017 |
| Last Verified: | November 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:
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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:
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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 |