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

Primary Purpose

Brain and Central Nervous System Tumors, Radiation Toxicity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EGb761
donepezil hydrochloride
cognitive assessment
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Western Regional, Arizona
  • Regional Radiation Oncology Center at Rome
  • Comprehensive Cancer Center at Wake Forest University
  • CCOP - Upstate Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00070161
Brief Title
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2001 (Actual)
Primary Completion Date
May 1, 2005 (Actual)
Study Completion Date
August 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Radiation Toxicity
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
EGb761
Intervention Type
Drug
Intervention Name(s)
donepezil hydrochloride
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward G. Shaw, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Regional Radiation Oncology Center at Rome
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1030
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16549835
Citation
Shaw EG, Rosdhal R, D'Agostino RB Jr, Lovato J, Naughton MJ, Robbins ME, Rapp SR. Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. J Clin Oncol. 2006 Mar 20;24(9):1415-20. doi: 10.1200/JCO.2005.03.3001.
Results Reference
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Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

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