A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME

Inclusion Criteria:

- Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma

- Newly diagnosed by surgical biopsy or excision within the past 5 weeks

- Supratentorial location, as determined by the following:

- Contrast-enhanced MRI performed preoperatively

- MRI performed postoperatively within 28 days prior to study entry (preferably
within 72 hours of surgery)

- Postoperative scan not required if diagnosed by stereotactic biopsy and
pre-operative MRI was performed

- No gliomas graded < GBM

- No recurrent malignant gliomas

- No tumor foci detected below the tentorium or beyond the cranial vault

- No multifocal disease or leptomeningeal spread

- Zubrod performance status 0-1

- Neurologic function status 0-2

- Absolute neutrophil count ≥ 1,800 cells/mm^3

- Platelet count ≥ 100,000 cells/mm^3

- Hemoglobin ≥ 8 g/dL (transfusion allowed)

- BUN ≤ 25 mg/dL

- Creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ 1.5 mg/dL

- ALT or AST ≤ 2 times upper limit of normal

- Fertile patients must use effective contraception during and for 2 months after
completion of study treatment

- Negative pregnancy test

- Not pregnant or nursing

- No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma
in situ of the uterine cervix or bladder, unless disease-free for ≥ 3 years

- No severe, active comorbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at study
entry

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days prior to
study entry

- Coagulation defects

- Known AIDS

- No prior allergic reaction to the study drugs

- No history of porphyria or G6PD deficiency

- No allergy to gadolinium or contraindications to MRI

- No other concurrent chemotherapy

- Recovered from effects of surgery or postoperative infection and other complications

- No prior systemic chemotherapy, including polifeprosan 20 with carmustine implant
(Gliadel wafer), for the current GBM

- Prior chemotherapy for a different cancer allowed

- No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would
result in overlap of radiation therapy fields

- No prophylactic filgrastim (G-CSF) during the first course of study treatment

- No concurrent sargramostim (GM-CSF)