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NCT Number: NCT00452868

Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain.

PURPOSE: This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain.

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Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Chemically-Induced Disorders Choroid Plexus Neoplasms Cognitive/Functional Effects Cranial Nerve Diseases Cranial Nerve Neoplasms Eye Diseases Familial ependymoma Glioma Long-term Effects Secondary to Cancer Therapy in Children Medulloblastoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neurotoxicity Neurotoxicity Syndromes Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Peripheral Nervous System Neoplasms Poisoning Psychosocial Effects of Cancer and Its Treatment Radiation Injuries Radiation Toxicity Spinal Cord Diseases Spinal Cord Neoplasms Wounds and Injuries

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Tufts-NEMC Cancer Center, Boston, Massachusetts, United States

About this study

OBJECTIVES:

Primary

Determine the impact of donepezil hydrochloride on cognitive function in pediatric patients with primary brain tumors previously treated with cranial radiotherapy.

Secondary

Assess health-related quality of life of patients treated with this drug.
Assess function and quality of life of the families of patients treated with this drug.
Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in patients treated with this drug.
Determine the toxicity of donepezil hydrochloride in these patients.

OUTLINE: This is a multicenter, pilot, open-label, controlled study.

Patients receive oral donepezil hydrochloride once daily or once every other day for up to 24 weeks in the absence of disease progression or unacceptable toxicity. After completion of 6 weeks of study therapy, patients are evaluated for toxicity. Patients experiencing no adverse effects from treatment may continue receiving donepezil hydrochloride at a higher dose for 18 more weeks.

Patients undergo measurement of cognitive function (by neurocognitive testing), behavioral adjustment and social competency (by parent-reported questionnaires), health-related quality of life (by child- and parent-reported questionnaires), and vascular dynamics (by transcranial Doppler ultrasound) at baseline and at weeks 12, 24, and 36. Family function and family quality of life are assessed at baseline and at week 24.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Prior diagnosis of primary brain tumor
No type 2 neurofibromatosis
Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
Karnofsky or Lansky performance status 70-100%
Fertile patients willing to use effective contraception
Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3
Stable weight within the past 6 months with no concern of weight loss
Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated
Able to speak English
More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug

Exclusion criteria

Stereotactic radiosurgery as sole treatment
Evidence of disease progression by MRI
Pregnant or nursing
Attention-deficit/hyperactivity disorder before cancer diagnosis
Uncontrolled seizures or uncontrolled endocrinopathies
Uncontrolled comorbidities
Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
Use of concurrent anticholinergic drugs

Treatment and study plan

Donepezil

Drug

Donepezil 5 milligrams a day for 6 weeks

Primary outcomes

Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks

Time frame: 24 weeks

Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Mar 28, 2007
Registry last updated: Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed