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Therapeutic Areas: Oncology
Disease Category: Brain Tumor

Trial Information

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors. PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.

DISEASE CHARACTERISTICS:

• Diagnosis of primary or metastatic brain tumor
• Completed a course of = 30 Gy fractionated whole-brain irradiation or large-field partial-brain irradiation for primary or metastatic brain tumor = 6 months prior to study entry

Meets the following criteria:

• Single-fraction stereotactic radiosurgery as a boost after external-beam radiotherapy
• No polifeprosan 20 with carmustine implant (Gliadel wafers), GliaSite®, or other type of brain brachytherapy
• No convection-enhanced delivery of immunotoxins
• No other investigational modalities as adjuvant therapy after external-beam radiotherapy
• Must have treatment records (total dose, dose per fraction, and isodose curves) available for all prior radiotherapy (external-beam radiotherapy, brachytherapy, and/or stereotactic radiosurgery)
• Patients receiving prophylactic cranial irradiation are eligible
• No radiographic evidence of brain disease OR stable brain disease, defined as no evidence of tumor progression within the past 3 months
• No brain metastases with progressive extracranial primary or metastatic disease

Extracranial primary or metastatic disease must be stable or have responded to local and/or systemic treatment within the past 3 months
PATIENT CHARACTERISTICS:

• Life expectancy = 30 weeks
• Karnofsky performance status 60-100%
• Patients must have a phone
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No sick sinus syndrome or supraventricular arrhythmias
• No hypersensitivity to donepezil hydrochloride

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 2 weeks since prior and no other concurrent dementia drugs, cognitive enhancers, neuroleptics, and/or anti-parkinsonian agents Concurrent steroids, anti-cholinergics, anti-epileptics, anti-depressants, and/or sedatives/benzodiazepines allowed provided patient is on a stable or decreasing dose
• Concurrent narcotic analgesics allowed provided the patient is on a stable dose and/or prn basis
• No other planned therapy, including surgery, brain irradiation of any type, chemotherapy, or immunotherapy, for the next 30 weeks for brain or extracranial primary metastatic disease
• Concurrent trastuzumab (Herceptin®) for breast cancer allowed
• Concurrent hormonal therapy for breast or prostate cancer allowed
• No concurrent bethanechol, ketoconazole, quinidine, or succinylcholine
• No prior GliaSite or other type of brain brachytherapy, convection enhanced delivery of immunotoxins, and/or any other investigational modalities for treatment of brain tumor
• Gliadel wafers allowed
• No concurrent chemotherapy

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education at Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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