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Study Summary
No. 2007-0532:.......Brain; CNS......Monica Loghin......Neuro Oncology
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Study Summary Title
Study Summary
Number:
2007-0532
Study Title:Phase III Double Blind, Placebo Controlled Study of Donepezil in Irradiated
Brain Tumor Patients
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Physician New Patient Referral
Name:Monica LoghinPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Neuro OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2883
Contact us about clinical trials
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General Information
Disease Group:Brain
CNS
Supported By:NCI
Pfizer, Inc
Phase of Study:Phase IIIReturn
Visit:
every 12 weeks
Treatment
Agents:
DonepezilHome Care:Patients will take donepezil at home
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find out if donepezil can treat
the symptoms of cognitive impairment, such as memory loss, confusion, and slow
thinking, which have occurred after getting radiation treatments for a brain
tumor. Researchers will also see if donepezil improves mood and quality of
life.
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Study Objectives / Outcomes
1. Primary Protocol Objectives

To determine whether administration of donepezil for 24 weeks to >/= 6 month survivors of partial or whole brain irradiation will improve the neurocognitive symptom cluster (objective cognitive performance deficits + subjective cognitive functional impairments) as compared to placebo. The specific hypothesis to be tested is:

1A. Overall cognitive performance will be improved in donepezil treated patients as compared to placebo treated patients at 24 weeks.

1B. Subjective cognitive complaints/symptoms will be improved in donepezil treated patients as compared to placebo treated patients at 24 weeks.

1C. Fatigue will be improved in donepezil treated patients as compared to placebo treated patients at 24 weeks.

2. Secondary Protocol Objectives

To determine whether administration of donepezil for 24 weeks to >/= 6 month survivors of partial or whole brain irradiation will improve mood and QOL as compared to placebo. The specific hypothesis to be tested is:

2A. Cancer-related quality of life will be improved in donepezil treated patients as compared to placebo treated patients at 24 weeks.

2B. Overall mood will be improved in donepezil treated patients as compared to placebo treated patients at 24 weeks.
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Study Status Information
Study Activation / Registration Date:01/29/2008
IRB Review and Approval Date:01/29/2008
Study Type:Phase Iii
Recruitment Status:Closed
Projected Accrual:200
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Adults >/= 18 years old.

2) Life expectancy of at least >/= 30 weeks.

3) Must have received a prior course of at least 30 Gy fractionated whole or partial brain irradiation for treatment of a primary brain tumor or metastatic disease to the brain.

4) Must have completed radiation >/= 6 months prior to enrollment and have no radiographic evidence of brain disease, or stable brain disease defined as no evidence of tumor progression in the 3 months prior to enrollment.

5) Patients who have undergone one or more treatments with single fraction stereotactic radiosurgery (SRS) in addition to whole or partial brain irradiation are eligible, as long as the SRS was completed >/= 6 months prior to registration if NED or stable disease.

6) Radiation treatment records must be available for all prior radiation treatments (external beam and/or SRS).

7) Patients who have received PCI (prophylactic cranial irradiation) are eligible.

8) Karnofsky Performance Status must be >/= 60 or ECOG 0-2.

9) Treatment with steroids, anti-cholinergics, anti-epileptics, anti-depressants, and /or sedatives/benzodiazepines is acceptable, but the patient must be on a stable or decreasing dose at the time of study entry.

10) Patients using narcotic analgesics on a stable dose and/or prn basis are eligible.

11) Patients currently on a stable dose of Methylphenidate or Dextramphetamine are eligible.

12) For patients with brain metastases, if extracranial primary or metastatic disease is present, it must have responded to local and/or systemic treatment. Must be stable in the 3 months prior to enrollment.

13) Must not be receiving chemotherapy at the time of enrollment.

14) Patient must not have any planned therapy, including surgery, brain radiation of any type, chemotherapy, or immunotherapy during the next 30 weeks for brain or extracranial primary metastatic disease.

15) Hormonal therapy for patients with breast or prostate cancer is acceptable.

16) Breast patients receiving therapy with Herceptin are allowed.

17) Patients must be able to give informed consent to participate in the study, including signing the consent form.

18) Patients must have a telephone.

Exclusion Criteria:1) Patients cannot be currently taking dementia drugs, cognitive enhancers, neuroleptics, and/or anti-parkinsonian agents. For patients who have used these drugs in the past, they must not have used them in the 2 weeks prior to enrolling on the study.

2) Patients may not currently be taking Ketoconazole or Quindine

3) Hypersensitivity to donepezil.

4) Arrythmias including bradycardia or heartblock

5) Patients who have received, GliaSite or other type of brain brachytherapy, (Gliadel Wafers permitted) convection enhanced delivery of immunotoxins, and/or any other investigational modalities for treatment of their brain tumor.

6) The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

7) It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.

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Links
Registration Number: NCT00369785
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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