Brain and Central Nervous System TumorsPhase 2NCT00070161
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
A Phase 2 study testing EGb761, donepezil hydrochloride and cognitive assessment in people with Brain and Central Nervous System Tumors and Radiation Toxicity, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Radiation Toxicity
- What is being tested?
- EGb761, donepezil hydrochloride and cognitive assessment
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2001to 1 Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1030
About this study
Official title: Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
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.
Read the 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)
- Being tested
- EGb761, donepezil hydrochloride, cognitive assessment
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Radiation Injuries, Glioma, Craniopharyngioma, Medulloblastoma, Meningioma, Choroid Plexus Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGb761Dietary supplement
donepezil hydrochlorideDrug
cognitive assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study start1 Jul 2001
- Primary completion1 May 2005
- Study completion1 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward G. Shaw, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070161
- Sponsor's protocol ID
- REBACCCWFU-97100
- Other IDs
- U10CA081851
- Status last verified
- Sep 2021
- First submitted
- 3 Oct 2003
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaw EG, Rosdhal R, D'Agostino RB Jr, Lovato J, Naughton MJ, Robbins ME, Rapp SR. Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. J Clin Oncol. 2006 Mar 20;24(9):1415-20. doi: 10.1200/JCO.2005.03.3001.
PubMed 16549835
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
- ClinicalTrials.gov ID
- NCT00070161
- Acronym / sponsor ID
- REBACCCWFU-97100
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2001 (actual)
- Primary completion
- 1 May 2005 (actual)
- Study completion
- 1 Aug 2012 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGb761 | Dietary supplement | – |
| donepezil hydrochloride | Drug | – |
| cognitive assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Results publication: PubMed 16549835Shaw EG, Rosdhal R, D'Agostino RB Jr, Lovato J, Naughton MJ, Robbins ME, Rapp SR. Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. J Clin Oncol. 2006 Mar 20;24(9):1415-20. doi: 10.1200/JCO.2005.03.3001.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward G. Shaw, MD study chair
Wake Forest University Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGb761, donepezil hydrochloride and cognitive assessment in people with Brain and Central Nervous System Tumors and Radiation Toxicity, run by Wake Forest University Health Sciences at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00070161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.