Clinical trial NCT00070161: Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
Official title: Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Radiation Toxicity
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
adult grade III meningioma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
adult ependymoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-10-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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)

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Rome
country: United States
facility: Regional Radiation Oncology Center at Rome
state: Georgia
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Edward G. Shaw, MD
role: STUDY_CHAIR
References:
citation: 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.