Clinical Trial Finder

Inclusion Criteria.

• - Histologically confirmed primary brain tumor, including any of the following: - Glioblastoma multiforme.

• - Anaplastic astrocytoma.

• - Anaplastic oligodendroglioma.

• - Anaplastic mixed oligoastrocytoma.

• - Low-grade glioma.

• - Meningioma.

• - Ependymoma.

• - Other primary brain tumor histologies.

• - Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain radiotherapy) meeting all of the following criteria: - Total dose ≥ 4,500 cGy.

• - Total number of fractions ≥ 25 fractions.

• - Dose per fraction ≥ 150 cGy.

PATIENT CHARACTERISTICS:

• - Karnofsky performance status 60-100% - Hemoglobin ≥ 10.0 g/dL (erythropoietin or transfusion allowed for symptomatically anemic patients with a hemoglobin < 10 g/dL) - Creatinine ≤ 2 mg/dL.

• - Total bilirubin ≤ 2 times upper limit of normal (ULN) - SGOT and SGPT ≤ 3 times ULN.

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Sexually active women of childbearing potential must use a reliable method of birth control.

• - It is recommended that patients use non-hormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with armodafinil.

• - Prior malignancies allowed.

Exclusion Criteria:

• - No baseline headaches (i.e., headaches occurring in the week before baseline assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living) - No concurrent uncontrolled illness that may cause fatigue; interfere with drug absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following: - Ongoing or active infection.

• - Chronic renal insufficiency.

• - Psychiatric illness (psychosis, psychotic disorder, history of suicide attempt, or actively suicidal) - Extreme social situations (e.g., transportation issues that would preclude study compliance) - Patients with a history of cardiac issues (symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG.

• - No history of allergic reaction attributed to modafinil or armodafinil.

• - No anticipated or planned excessive consumption of coffee, tea, and/or caffeine-containing beverages averaging > 600 mg of caffeine/day (i.e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day) PRIOR CONCURRENT THERAPY: - See Disease Characteristics.

• - No prior fractionated external-beam cranial radiotherapy.

• - More than 30 days since prior monoamine oxidate inhibitors or investigational drugs.

• - More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil (Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs.

• - At least 4 weeks since prior and no concurrent interstitial or intracavitary chemotherapy and/or radiotherapy or stereotactic radiosurgery (i.e., Gamma Knife, Linac, or Cyberknife) - No concurrent erythropoietin, transfusion, or iron therapy (unless patient is symptomatically anemic with hemoglobin < 10 g/dL) - Concurrent chemotherapy allowed.

• - Concurrent hormonal therapy for other malignancies allowed.

• - No concurrent non-hormonal therapy (e.g., Herceptin and other targeted agents), or cytotoxic chemotherapy.

- No concurrent clopidogrel bisulfate (Plavix)

OBJECTIVES: Primary.

• - To estimate study accrual, adherence, retention, and participation of patients with primary brain tumors undergoing partial- or whole-brain radiotherapy who are randomized to receive armodafinil or placebo.

• - To estimate the variability of fatigue, quality of life, and neurocognitive function in these patients.

Secondary.

• - To obtain a preliminary estimate of the effect of armodafinil on fatigue as measured by the fatigue subscale of the FACIT-F and the Brief Fatigue Inventory.

• - To estimate the rates of toxicity and adverse events associated with armodafinil.

• - To obtain preliminary estimates of the effect of armodafinil on sleepiness as measured by the Epworth Sleep Scale; overall quality of life and brain-specific quality of life as measured by the FACT-G with the brain subscale; and cognitive function as measured by a comprehensive Wake Forest Cognitive Function Battery.

OUTLINE: This is a multicenter study. Patients are stratified according to therapy (radiotherapy alone vs.#46;radiotherapy and chemotherapy) and Karnofsky performance status (60-80% vs.#46;90-100%). Patients are randomized to 1 of 2 arms.

• - Arm I: Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

• - Arm II: Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Patients complete questionnaires assessing fatigue, quality of life, and neurocognitive function at baseline and periodically during study.

Arms

Experimental: Arm I - Armodafinil

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Placebo Comparator: Arm II - Placebo

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Interventions

Drug: - Armodafinil

Given orally

Other: - placebo

Given orally