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

Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas

The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.

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