A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

Inclusion Criteria:

• At least 18 years old
• Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
• ECOG performance status score of 0, 1, or 2
• Each patient must sign a study-specific informed consent form

Exclusion Criteria:

Laboratory values of:

• Absolute neutrophil count < 2000/µL
• Platelet count < 100,000/µL
• AST or ALT > 2 x the upper limit of normal (ULN)
• Alkaline phosphatase > 5 x ULN
• Bilirubin > 2 x ULN
• Creatinine > 2.0 mg/µL

and

• Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
• Women who are pregnant or lactating