Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients
18 Years
N/A
Both
Brain and Central Nervous System Tumors, Radiation Toxicity
Trial Information
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients
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)
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Edward G. Shaw, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CDR0000330114
NCT ID:
NCT00070161
Start Date:
March 2004
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Radiation Toxicity
- radiation toxicity
- adult mixed glioma
- adult central nervous system germ cell tumor
- adult brain stem glioma
- adult craniopharyngioma
- adult medulloblastoma
- adult meningioma
- adult choroid plexus tumor
- adult tumors metastatic to brain
- adult anaplastic oligodendroglioma
- adult anaplastic astrocytoma
- adult pilocytic astrocytoma
- adult subependymoma
- adult meningeal hemangiopericytoma
- adult ependymoblastoma
- adult anaplastic ependymoma
- adult pineoblastoma
- adult pineocytoma
- adult myxopapillary ependymoma
- adult glioblastoma
- adult grade III meningioma
- adult oligodendroglioma
- adult giant cell glioblastoma
- adult gliosarcoma
- adult ependymoma
- Brain Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Radiation Injuries
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| Regional Radiation Oncology Center at Rome | Rome, Georgia 30165 |
