Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
Condition: 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
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Neurotoxicity Syndromes
Study type: Interventional
Phase: Early Phase 1

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.
    

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.
    

Intervention name(s): Donepezil
Intervention type(s): Drug
Intervention description(s): Donepezil 5 milligrams a day for 6 weeks
Intervention MeSH terms: Donepezil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: 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