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

Inclusion Criteria:

• Age ≥ 18 years
• 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 > 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)
• 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 per the second eligibility criteria, but chemotherapy is allowed.

• Negative serum pregnancy test done ≤ 7 days prior to registration only for women determined to be of childbearing potential by the 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:

• Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
• History of hypersensitivity to other psychostimulants
• History of steroid psychosis
• History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self report
• 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 and plans to continue for the duration of the trial. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.
• Anticipating surgery, laboratory evidence of hypothyroidism with an elevated thyroid stimulating hormone (TSH) concentration in the blood > 5.0 mlU/L, profound anemia (hemoglobin level of < 10 g/dL ≤ 28 days prior to registration), or clinical depression per physician discretion
• Active or a history of Tourrette's syndrome or tic disorder
• History of or active glaucoma
• History of intractable epilepsy, or uncontrolled seizure disorder

• 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:

  1. History of myocardial infarction
  2. Unstable angina
  3. Left ventricular hypertrophy
  4. Mitral valve prolapse syndrome

• Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 3A4 (CYP3A4). Use of the following strong or moderate inhibitors are prohibited ≤ 7 days prior to registration:

  1. Strong Inhibitors of CYP3A4:
 > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance
:

     1. Indinavir (Crixivan®)

     2. Nelfinavir (Viracept®)

     3. Atazanavir (Reyataz®)

     4. Ritonavir (Norvir®)

     5. Clarithromycin (Biaxin®, Biaxin XL®)

     6. Itraconazole (Sporanox®)

     7. Ketoconazole (Nizoral®)

     8. Nefazodone (Serzone®)

     9. Saquinavir (Fortovase®, Invirase®)

     10. Telithromycin (Ketek®)


  2. Moderate Inhibitors of CYP3A4
: > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance
:

     1. Aprepitant (Emend®)
     2. Erythromycin (Erythrocin®, E.E.S. ®, Ery-Tab®, Eryc®, EryPed®, PCE®
)
     3. Fluconazole (Diflucan®)

     4. Grapefruit juice

     5. Verapamil (Calan®, Calan SR®, Covera-HS®, Isoptin SR®, Verelan®, Verelan PM®)
     6. 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:
 Efavirenz (Sustiva®)
, Nevirapine (Viramune®)
, Carbamazepine (Carbatrol®, Epitol®, Equetro™, Tegretol®, Tegretol-XR®)
, Modafinil (Provigil®)
, Phenobarbital (Luminal®), Phenytoin (Dilantin®, Phenytek®)
, Pioglitazone (Actos®)
, Rifabutin (Mycobutin®)
, Rifampin (Rifadin®) and St. John's Wort