Clinical Trial Details
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NCT02490930 : A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
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
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