Brain and Central Nervous System TumorsEarly Phase 1NCT00452868
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
A Early Phase 1 study testing Donepezil in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children
- What is being tested?
- Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Feb 2010
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prior diagnosis of primary brain tumor
- No type 2 neurofibromatosis
- Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
- Karnofsky or Lansky performance status 70-100%
- Fertile patients willing to use effective contraception
- Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3
Show all 10Show fewer
- Stable weight within the past 6 months with no concern of weight loss
- Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated
- Able to speak English
- More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug
Who cannot join
- Stereotactic radiosurgery as sole treatment
- Evidence of disease progression by MRI
- Pregnant or nursing
- Attention-deficit/hyperactivity disorder before cancer diagnosis
- Uncontrolled seizures or uncontrolled endocrinopathies
- Uncontrolled comorbidities
- Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
- Use of concurrent anticholinergic drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts-NEMC Cancer Center
Boston, Massachusetts, 02111
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
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.
Read the 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.
- Conditions
- 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
- Being tested
- Donepezil
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Neurotoxicity Syndromes, Radiation Injuries, Choroid Plexus Neoplasms, Spinal Cord Neoplasms, Medulloblastoma, Optic Nerve Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Donepezil 5 milligrams a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Donepozil | Experimental | Donepezil 5 milligrams a day for 6 weeks Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startJun 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- Sharon M. Castellino, MD, FAAP, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452868
- Sponsor's protocol ID
- CDR0000537049
- Other IDs
- P30CA012197, CCCWFU-91305, CCCWFU-IRB-00000258
- Status last verified
- Aug 2018
- First submitted
- 27 Mar 2007
- Last updated
- 7 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
- ClinicalTrials.gov ID
- NCT00452868
- Acronym / sponsor ID
- CDR0000537049
- Conditions
- 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
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006 (actual)
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Posted 28 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donepozil | Experimental | Drug: DonepezilDonepezil 5 milligrams a day for 6 weeks |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Prior diagnosis of primary brain tumor
- No type 2 neurofibromatosis
- Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
- Karnofsky or Lansky performance status 70-100%
- Fertile patients willing to use effective contraception
Key exclusion criteria (8 listed)
- Stereotactic radiosurgery as sole treatment
- Evidence of disease progression by MRI
- Pregnant or nursing
- Attention-deficit/hyperactivity disorder before cancer diagnosis
- Uncontrolled seizures or uncontrolled endocrinopathies
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 |
|---|---|---|
| DonepezilDonepezil 5 milligrams a day for 6 weeks | Drug | Donepozil |
Primary outcome
Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
Time frame: 24 weeks
Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Brain and Central Nervous System Tumors
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
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.
Sharon M. Castellino, MD, FAAP study chair
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Donepezil in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Wake Forest University Health Sciences at 2 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?
The sponsor lists 10 inclusion and 8 exclusion criteria. 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2018.