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