A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma

Pts. must have hist. conf. dx of GBM/ gliosarcoma; bx or srg resection w/in 28 days prior to registration;MRI w/gadolinium after surgery, but before registration if tumor removal is greater than simple bx; pts who have had a simple bx only require the preoperative MRI w/gadolinium; note: bx will be considered a procedure done for diagnostic rather than therapeutic purposes with NO attempt at debulking; no prior radiation therapy delivered cephalad to the interspace between the 7th cervical vertebral body and the 1st thoracic vertebral body; cannot have 3 or more noncontiguous sites of tumor based on T2 MRI; no prior chemo.; no prior concomitant drugs with antineoplastic activity; no other invest. drugs or hormanal therapy; use of corticosteroids allowed provided that the dose is stable or decreasing following initial srg. prior to obtaining MRI; institutions must be willing to submit 1-2 H&E slides for central path review and 3-9 unstained slides for AGT IHC assay; serum creatinine less than or equal to 1.5 x IULN or creatinine clearance greater than or equal to 60 ml/min, PT/PTT less than or equal to 120% of the ULN w/i 28 days prior to registration; DLCO greater than 70% of predicted within 42 days prior to registration; pts must be at least 18 yrs of age; PS of less than or equal to 2; pts must not be known to be HIV positive; pts must not be pregnant or nursing;pts must not have known allergies to any of the study drugs; pts must not have other medical illesses which in the Inv's opinion cannot be adequately controlled (see Sect 5.15). Note: Pts may have a CT scan w/IV contrast if MRI is not medically feasible.