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Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases Clinical research trials and Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases clinical trial. Participants oftentimes recieve the most expert healthcare available for their Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
For Condition: brain metastases,adult brain tumor,radiation toxicity
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of donepezil and EGb761 in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - No 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardShaw, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
Additional Information:
Study ID Numbers: CDR0000330114; CCCWFU-97100,CCCWFU-BG00-225
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070161
Other Brain Metastases Studies:
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2. Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
4. Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer
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Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
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