Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

Summary: RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such as thinking, attention, concentration, and memory) and may improve quality of life in patients who have undergone radiation therapy to the brain.
  PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration.
  Secondary
  -  Determine the toxicity of these drugs in these patients.
  -  Determine the quality of life of patients treated with these drugs.
  -  Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs.
  OUTLINE: This is an open-label, multicenter study.
  -  Group 1 (closed to accrual 10/09/03): Patients receive oral donepezil once daily for 24 weeks.
  -  Group 2: Patients receive oral EGb761 three times daily for 24 weeks. In both groups (group 1 closed to accrual 10/09/03), treatment continues in the absence of unacceptable toxicity.
  In both groups (group 1 closed to accrual 10/09/03), quality of life and neurocognitive assessment is performed at baseline and at weeks 6 (group 1 only), 12, 24, and 30.
  Patients are followed at 6 weeks.
  PROJECTED ACCRUAL: A total of 70 patients (35 per treatment group) will be accrued for this study within 9.5 months. (Group 1 closed to accrual 10/09/03)

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of primary brain tumor or brain metastases, meeting 1 of the following criteria:
  -  No radiographic evidence of disease
  -  Stable disease, defined as no tumor progression within the past 3 months
  -  Previously treated with 1 course of localized or whole brain radiotherapy of at least 3,000 cGy at least 6 months before study registration
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  Karnofsky 70-100%
  Life expectancy
  -  At least 30 weeks
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  No concurrent chemotherapy
  Endocrine therapy
  -  Concurrent steroid therapy allowed if on stable or decreasing dose
  Radiotherapy
  -  See Disease Characteristics
  -  No concurrent cranial radiotherapy
  Surgery
  -  No concurrent surgery
  Other
  -  More than 3 months since prior donepezil or EGb761
  -  No concurrent donepezil (group 2 only)
  -  No concurrent EGb761 (group 1 only) (closed to accrual 10/09/03)
  -  No concurrent anticoagulants (e.g., aspirin, dipyridamole, heparin, warfarin, or enoxaparin) (group 2 only)
  -  No concurrent monoamine oxidase inhibitors (e.g., phenelzine or tranylcypromine)
  -  No other concurrent therapy

Relevance to patient case: not relevant