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

NCT00070161 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: REBACCCWFU-97100U10CA081851
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Interventions

EGb761 DIETARY_SUPPLEMENT

donepezil hydrochloride DRUG

cognitive assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

Comprehensive Cancer Center at Wake Forest University

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

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

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: 16549835 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Radiation Injuries; Glioma; Craniopharyngioma; Medulloblastoma; Meningioma; Choroid Plexus Neoplasms; Brain Neoplasms; Oligodendroglioma; Astrocytoma; Glioma, Subependymal; Neuroectodermal Tumors, Primitive; Ependymoma; Pinealoma; Glioblastoma; Gliosarcoma

Interventions

Ginkgo biloba extract; Donepezil; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Wounds and Injuries; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Cerebral Ventricle Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

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
• Primary Completion: May 1, 2005
• Study Completion: August 1, 2012
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)