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Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Radiation Toxicity

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Trial Information

Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor Patients


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)

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Edward G. Shaw, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000330114

NCT ID:

NCT00070161

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Radiation Toxicity
  • 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
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Radiation Injuries

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Regional Radiation Oncology Center at RomeRome, Georgia  30165