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