Armodafinil in Reducing Cancer-Related Fatigue in Patients with High-Grade Glioma

Inclusion Criteria

• Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month
• >= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion
• Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed; patients who are currently using Optune device will be eligible to participate in this trial
• Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician
• Ability to complete questionnaire(s) by themselves or with assistance
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3
• Provide informed written consent
• Willing to return to enrolling institution for follow-up (during the Active Monitoring phase of the study)
• Stable dose of corticosteroid >= 14 days prior to registration

Exclusion Criteria

• Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception
• History of hypersensitivity to other psychostimulants
• History of steroid psychosis
• Currently taking medications for attention deficit hyperactivity disorder, history of or currently taking medications for severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self-report * Note: Patients who had childhood attention deficit hyperactivity disorder (ADHD) and no longer require treatment will be eligible to participate
• Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue, including psychostimulants, antidepressants, acupuncture, etc. will be excluded; Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for the duration of the trial; erythropoietin agents to treat anemia are allowed; exercise is allowed
• Anticipating surgery
• Uncontrolled hypothyroidism, profound anemia (hemoglobin level of <10 g/dL =< 28 days prior to registration), or untreated clinical depression per physician discretion. Patients with stable, controlled depression or receiving treatment for hypothyroidism will be eligible, if they have been on a stable dose for the past 30 days and plan to continue for the duration of the trial.
• Active or a history of Tourette’s syndrome or tic disorder
• History of or active glaucoma
• History of intractable epilepsy
• Any of the following co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens: * History of myocardial infarction * Unstable angina * Left ventricular hypertrophy * Mitral valve prolapse syndrome
• Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration * Strong inhibitors of CYP3A4: ** > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance ** Indinavir (Crixivan) ** Nelfinavir (Viracept) ** Atazanavir (Reyataz) ** Ritonavir (Norvir) ** Clarithromycin (Biaxin, Biaxin XL) ** Itraconazole (Sporanox) ** Ketoconazole (Nizoral) ** Nefazodone (Serzone) ** Saquinavir (Fortovase, Invirase) ** Telithromycin (Ketek) * Moderate Inhibitors of CYP3A4 ** > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance ** Aprepitant (Emend) ** Erythromycin (Erythrocin, E.E.S., Ery-Tab, Eryc, EryPed, PCE) ** Fluconazole (Diflucan) ** Grapefruit juice ** Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM) ** Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)
• Receiving any medications or substances that are inducers of CYP3A4; use of the following inducers are prohibited =< 7 days prior to registration * Inducers of CYP3A4 ** Efavirenz (Sustiva) ** Nevirapine (Viramune) ** Carbamazepine (Carbatro, Epitol, Equetro, Tegretol, Tegretol-XR) ** Modafinil (Provigil) ** Phenobarbital (Luminal) ** Phenytoin (Dilantin, Phenytek) ** Pioglitazone (Acto) ** Rifabutin (Mycobutin) ** Rifampin (Rifadin) ** St. John’s wort