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Donepezil or EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases

This study has been completed.

Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070161
  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
Cancer-Related Problem/Condition
Drug: EGb761
Drug: donepezil hydrochloride
Procedure: cognitive assessment
Phase II

MedlinePlus related topics:   Brain Cancer    Cancer   

Drug Information available for:   Donepezil    E 2020   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Open Label
Official Title:   Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2004

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 and older
Genders Eligible for Study:   Both
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

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
National Cancer Institute (NCI)

Investigators
Study Chair:     Edward G. Shaw, MD     Wake Forest University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000330114, CCCWFU-97100, CCCWFU-BG00-225
First Received:   October 3, 2003
Last Updated:   November 22, 2008
ClinicalTrials.gov Identifier:   NCT00070161
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 30, 2008




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