Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
Condition: Brain Tumors; Nervous System Tumors; Cognition Disorders; Fatigue
MeSH terms: Neoplasms; Brain Neoplasms; Nervous System Neoplasms; Fatigue; Cognition Disorders
Intervention: Armodafinil; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fatigue; cognitive/functional effects; adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult pineal gland astrocytoma; adult subependymal giant cell astrocytoma; adult oligodendroglioma; adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult anaplastic meningioma; adult grade I meningioma; adult grade II meningioma; adult grade III meningioma; adult papillary meningioma; adult brain stem glioma

Summary:

      RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with
      cancer receiving radiation therapy to the brain.

      PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue
      caused by radiation therapy in patients with primary brain tumors.
    

Eligibility criteria:

        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)