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Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070161
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:

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

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)

Study Design
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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
Actual Study Start Date : July 1, 2001
Actual Primary Completion Date : May 1, 2005
Actual Study Completion Date : August 1, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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


Locations
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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
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Study Chair: Edward G. Shaw, MD Wake Forest University Health Sciences
More Information
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Publications of Results:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00070161    
Other Study ID Numbers: REBACCCWFU-97100
U10CA081851 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2003    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Donepezil
Cholinesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents