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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.
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00070161
First received: October 3, 2003
Last updated: August 20, 2009
Last verified: August 2009
  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: Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

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
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

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 Baptist Health
Investigators
Study Chair: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00070161     History of Changes
Other Study ID Numbers: CDR0000330114, CCCWFU-97100, CCCWFU-BG00-225
Study First Received: October 3, 2003
Last Updated: August 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
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:
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Radiation Injuries
Neoplasms by Site
Nervous System Diseases
Wounds and Injuries
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014