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Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain


Phase 3
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue, Metastatic Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity

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Trial Information

Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain


OBJECTIVES:

Primary

- Compare the effect of donepezil hydrochloride vs placebo, in terms of improving
neurocognitive symptom cluster (i.e., cognitive impairment, subjective confusion, and
fatigue), in patients who have undergone partial- or whole-brain irradiation for brain
tumors.

Secondary

- Compare the effect of these regimens on mood and quality of life in these patients.

OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized, multicenter
study. Patients are stratified according to prior brain irradiation type (whole-brain vs
partial-brain) and study site. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral donepezil hydrochloride once or twice daily for up to 24
weeks in the absence of unacceptable toxicity.

- Arm II: Patients receive oral placebo once or twice daily for up to 24 weeks in the
absence of unacceptable toxicity.

Patients complete self-reported questionnaires (quality of life, fatigue, subjective
confusion, neurocognitive battery, and mood) at baseline and 12 and 24 weeks.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Fatigue, subjective confusion, and cognitive performance at 24 weeks

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Stephen Rapp, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU91105

NCT ID:

NCT00369785

Start Date:

January 2008

Completion Date:

June 2012

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Cognitive/Functional Effects
  • Fatigue
  • Metastatic Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • cognitive/functional effects
  • fatigue
  • psychosocial effects of cancer and its treatment
  • radiation toxicity
  • tumors metastatic to brain
  • adult brain stem glioma
  • adult central nervous system germ cell tumor
  • adult choroid plexus tumor
  • adult craniopharyngioma
  • adult mixed glioma
  • adult anaplastic meningioma
  • meningeal melanocytoma
  • adult meningeal hemangiopericytoma
  • adult grade I meningioma
  • adult grade II meningioma
  • adult grade III meningioma
  • adult papillary meningioma
  • adult anaplastic oligodendroglioma
  • adult oligodendroglioma
  • adult pineoblastoma
  • adult pineocytoma
  • adult anaplastic astrocytoma
  • adult diffuse astrocytoma
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pilocytic astrocytoma
  • adult ependymoblastoma
  • adult medulloblastoma
  • adult supratentorial primitive neuroectodermal tumor (PNET)
  • adult anaplastic ependymoma
  • adult ependymoma
  • adult myxopapillary ependymoma
  • adult subependymoma
  • Fatigue
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Radiation Injuries

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - MeritCare HospitalFargo, North Dakota  58122
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Lakes Region General HospitalLaconia, New Hampshire  03246
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Trinity CancerCare CenterMinot, North Dakota  58701
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine  04240