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

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ClinicalTrials.gov Identifier: NCT00452868
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : February 28, 2013
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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 or disease Intervention/treatment Phase
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 Early Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
Actual Study Start Date : June 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010


Arm Intervention/treatment
Experimental: Donepozil
Donepezil 5 milligrams a day for 6 weeks
Drug: Donepezil
Donepezil 5 milligrams a day for 6 weeks




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452868


Locations
United States, Massachusetts
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Sharon M. Castellino, MD, FAAP Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00452868     History of Changes
Other Study ID Numbers: CDR0000537049
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU-91305 ( Other Identifier: Comprehensive Cancer Center of WFUHS )
CCCWFU-IRB-00000258 ( Other Identifier: WFUHS IRB )
First Posted: March 28, 2007    Key Record Dates
Results First Posted: February 28, 2013
Last Update Posted: September 7, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
long-term effects secondary to cancer therapy in children
psychosocial effects of cancer and its treatment
childhood central nervous system germ cell tumor
childhood choroid plexus tumor
childhood spinal cord neoplasm
childhood brain stem glioma
childhood supratentorial primitive neuroectodermal tumor
childhood cerebral astrocytoma/malignant glioma
cognitive/functional effects
neurotoxicity
radiation toxicity
childhood craniopharyngioma
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
childhood cerebellar astrocytoma
childhood medulloblastoma
childhood visual pathway and hypothalamic glioma
childhood subependymal giant cell astrocytoma
childhood ependymoma

Additional relevant MeSH terms:
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Neurotoxicity Syndromes
Radiation Injuries
Central Nervous System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents