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


N/A
8 Years
17 Years
Open (Enrolling)
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks

Outcome Description:

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

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Sharon M. Castellino, MD, FAAP

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000537049

NCT ID:

NCT00452868

Start Date:

June 2006

Completion Date:

Related Keywords:

  • 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
  • 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
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neurotoxicity Syndromes
  • Radiation Injuries

Name

Location
Tufts-NEMC Cancer Center Boston, Massachusetts  02111
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096