Research & Trial Information
Protocol# Alliance – A0221101
Cancer Type: Brain Cancer Control
2. 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 prior to registration. NOTE: Clinical stability will be defined as a stable or improved KPS compared to the prior month.
3. 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.
4. ECOG Performance Status (PS) of 0, 1, 2 or 3.
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
2. History of hypersensitivity to other psychostimulants.
3. History of steroid psychosis.
4. 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 ADHD and no longer require treatment will be eligible to participate.
5. 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.
6. Anticipating surgery
7. 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.
8. Any history of Tourrette’s syndrome or tic disorder.
9. Any history of or active glaucoma.
10. Any history of intractable epilepsy.
11. 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
12. Receiving any medications or substances that are strong or moderate inhibitors of CYP3A4.
13. Receiving any medications or substances that are inducers of CYP3A4.