Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors Radiation Toxicity

Keywords

radiation toxicityadult mixed gliomaadult central nervous system germ cell tumoradult brain stem gliomaadult craniopharyngiomaadult medulloblastomaadult meningiomaadult choroid plexus tumoradult tumors metastatic to brainadult anaplastic oligodendrogliomaadult anaplastic astrocytomaadult pilocytic astrocytomaadult subependymomaadult meningeal hemangiopericytomaadult ependymoblastomaadult anaplastic ependymomaadult pineoblastomaadult pineocytomaadult myxopapillary ependymomaadult glioblastomaadult grade III meningiomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcomaadult ependymoma

Interventions

EGb761Dietary supplement

donepezil hydrochlorideDrug

cognitive assessmentProcedure

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Wake Forest University Health Sciences
Otherlead

Study Sites (4)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Related Publications (1)

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.
PMID: 16549835RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsRadiation InjuriesGliomaCraniopharyngiomaMedulloblastomaMeningiomaChoroid Plexus NeoplasmsBrain NeoplasmsOligodendrogliomaAstrocytomaGlioma, SubependymalNeuroectodermal Tumors, PrimitiveEpendymomaPinealomaGlioblastomaGliosarcoma

Interventions

Study Officials

Edward G. Shaw, MD
Wake Forest University Health Sciences
STUDY CHAIR

Enrollment

68 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

July 1, 2001

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations