Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00452868

Purpose

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.

Condition	Intervention
Brain and Central Nervous System Tumors Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity	Drug: donepezil hydrochloride Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: ultrasound imaging

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Active Control
Official Title:	A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors Radiation Therapy

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of donepezil hydrochloride on neurocognitive function as measured by the neurocognitive battery at 24 weeks

Secondary Outcome Measures:

Comparison of baseline dynamic vascular analysis (DVA™) indices in pediatric patients who score < 70 vs pediatric patients who score > 70 on the Peabody Picture Vocabulary Test-3
Correlation of changes in DVA™ indices with changes in cognitive function
Health-related quality of life (QOL) as measured by Child Report of QOL and Pediatric QOL Inventory (parent and child components) at baseline and at 12, 24, and 36 weeks
Family impact as measured by Life Events, Pediatric Inventory for Parents, and Impact on Family at week 24
Toxicity as measured by NCI CTCAE v3.0
Barriers to recruitment and retention of pediatric patients

Estimated Enrollment:	35
Study Start Date:	June 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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
- No stereotactic radiosurgery as sole treatment
No evidence of disease progression by MRI

PATIENT CHARACTERISTICS:

Karnofsky or Lansky performance status 70-100%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must 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
No attention-deficit/hyperactivity disorder before cancer diagnosis
No uncontrolled seizures or uncontrolled endocrinopathies
No uncontrolled comorbidities

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug
No steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
No other concurrent anticholinergic drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452868

Locations

United States, Massachusetts
Tufts-NEMC Cancer Center	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Susan K. Parsons, MD, MRP 617-636-6212 SParsons@tuftsmedicalcenter.org
United States, North Carolina
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Sharon M. Castellino, MD, FAAP

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000537049, CCCWFU-91305, CCCWFU-IRB-00000258
Study First Received:	March 27, 2007
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00452868 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cognitive/functional effects
neurotoxicity
long-term effects secondary to cancer therapy in children
psychosocial effects of cancer and its treatment
radiation toxicity
childhood central nervous system germ cell tumor
childhood choroid plexus tumor
childhood craniopharyngioma
childhood grade I meningioma
childhood grade II meningioma

childhood grade III meningioma
childhood spinal cord neoplasm
childhood brain stem glioma
childhood cerebellar astrocytoma
childhood medulloblastoma
childhood supratentorial primitive neuroectodermal tumor
childhood visual pathway and hypothalamic glioma
childhood subependymal giant cell astrocytoma
childhood ependymoma
childhood cerebral astrocytoma/malignant glioma

Study placed in the following topic categories:

Choroid Plexus Neoplasms
Neurotransmitter Agents
Neuroectodermal Tumors, Primitive
Neurotoxicity Syndromes
Disorders of Environmental Origin
Central Nervous System Neoplasms
Cholinergic Agents
Brain Diseases
Ependymoma
Donepezil
Craniopharyngioma
Neoplasm Metastasis
Neuroepithelioma
Meningioma

Glioma
Nervous System Neoplasms
Nootropic Agents
Astrocytoma
Spinal Cord Neoplasm
Poisoning
Central Nervous System Diseases
Brain Tumor, Childhood
Neuroectodermal Tumors
Brain Neoplasms
Cholinesterase Inhibitors
Brain Stem Glioma, Childhood
Medulloblastoma
Spinal Cord Neoplasms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotoxicity Syndromes
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Neoplasms
Brain Diseases
Cholinergic Agents
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Donepezil

Neoplasm Metastasis
Nervous System Neoplasms
Nootropic Agents
Nervous System Diseases
Poisoning
Central Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Brain Neoplasms
Cholinesterase Inhibitors
Neoplasms
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009