Fingolimod Hydrochloride in Reducing Radiation-Related Lymphopenia in Patients with Newly Diagnosed High-Grade Glioma Undergoing Radiation Therapy and Receiving Temozolomide

Inclusion Criteria

• Patients with newly diagnosed World Health Organization (WHO) grade III or IV astrocytoma who will undergo concomitant radiation and temozolomide followed by adjuvant temozolomide
• Minorities will be recruited; no exclusion to this study will be based on race
• Patients must have histologically confirmed high grade astrocytoma, WHO grade III or IV, by pathology
• Patients’ proposed post-operative treatment plan must include standard focal brain irradiation and temozolomide
• Patients must have a Karnofsky performance status >= 60 % (i.e. the patient must be able to care for himself/herself with occasional help from others)
• Patients must have normal bone marrow function, with a baseline total lymphocyte count >= 1000
• Patients must be able to provide informed consent
• Glucocorticoid use is allowed
• Women of childbearing potential should use effective contraception during and for two months after stopping fingolimod

Exclusion Criteria

• Patients must not have received prior radiation therapy, systemic chemotherapy, immunotherapy, therapy with biologic agents or hormonal therapy for their brain tumor
• Patients must not have recent (within six months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III/IV heart failure
• Patients must not have history of or presence of Mobitz type II 2nd degree or 3rd degree atrioventricular block or sick sinus syndrome, unless patient has a pacemaker
• Patients must not have baseline corrected QT (QTc) interval >= 500 ms
• Patients must not be on treatment with class Ia or class III antiarrhythmic drugs
• Patients must not have a history of macular edema, uveitis or diabetes mellitus
• Patients must not have elevated liver transaminase levels; adequate liver function is defined as total bilirubin =< 1.5 times upper limit of normal, serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 times upper limit of normal and serum albumin >= 2 g/dL
• Patients must not have an active infection
• Patients with known human immunodeficiency virus (HIV) will be excluded
• Patients with collagen vascular disease are excluded
• Patients taking immunosuppressive medications (other than dexamethasone) will be excluded