A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma
Glioblastoma, Anaplastic Astrocytoma
About this trial
This is an interventional other trial for Glioblastoma focused on measuring lymphopenia
Eligibility Criteria
Inclusion Criteria:
- Gender: Male and Female
- Age: Patients must be at least 18 years of age.
- Race: 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, 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 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, SGPT (ALT) < 5 times upper limit of normal and serum albumin > 2 g/dL.
- Patients must not have an active infection.
- Patients with known HIV will be excluded.
- Patients with collagen vascular disease are excluded.
- Patients taking immunosuppressive medications (other than dexamethasone) will be excluded.
Sites / Locations
- The Johns Hopkins University
Arms of the Study
Arm 1
Experimental
Experimental
Five evaluable patients with newly diagnosed high grade gliomas who will undergo standard concomitant radiation and temozolomide followed by adjuvant temozolomide will be accrued to this open-label, single arm, safety study. Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and temozolomide and will be discontinued immediately upon completion of the six weeks of therapy. Fingolimod will be administered at 0.5 mg every day for the first two weeks. Beginning the third week, they will take fingolimod on Monday, Wednesday and Friday until the end of radiotherapy or until the 28th dose, whichever comes first.