A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas

Inclusion Criteria

• •Prior histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligo-astrocytoma, glioblastoma multiforme, or gliosarcoma, for whom no other effective therapy is available.
• •A prior histologic diagnosis of a lower grade of glioma is allowed if there is current histologic proof of progression to a diagnosis of AA, AO, AOA, GBM or GS
• •Unequivocal evidence of recurrence or progression by neuroimaging procedure.
• •Surgical resection at least 2 weeks prior to enrollment and must have completely recovered from the side effects.
• •A stable dose of steroids for at least 7 days prior to obtaining the Gd-MRI of the brain.
• •Previously implanted Gliadel® wafer may be eligible.
• •Karnofsky Performance Status (KPS) of ≥ 60.
• •Laboratory parameters: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dl, Platelets ≥ 100 x 109/L, AST and ALT ≤ 3.0 x Upper Limit of Normal (ULN), Serum bilirubin ≤ 1.5 x ULN, Serum creatinine ≤ 1.5 x ULN and 24 hour creatinine clearance ≥ 50 ml/min
• •Life expectancy of greater than 12 weeks.
• •Written informed consent obtained.