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|NCT02490930 : A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma|
|Phase||Early Phase 1|
|Ages||Min: 18 Years Max: N/A|
- 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.
- 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
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02490930
| Link to official Clinicaltrials.gov listing