| Inclusion Criteria: | 1) Have histologically proven World Health Organization (WHO) Grade IV glioblastoma multiforme at the time of diagnosis or relapse.
2) Be capable of understanding the informed consent form (ICF) and complying with the protocol, and must sign the ICF prior to the performance of any study-related procedures.
3) Have had prior treatment with radiotherapy and temozolomide.
4) Have evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI.
5) Be a minimum of 4 weeks since prior surgical resection or major surgical procedure.
6) Be a minimum of 4 weeks since radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU).
7) Be age 18 or older.
8) Have a Performance score of Karnosfsky >/= 60%, or Eastern Cooperative Oncology Group (ECOG) </= 2, or WHO </= 2 .
9) If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week prior to first dose of study medication.
10) Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy to CTC grade </= 1.
11) Have the following laboratory parameters: a). Hemoglobin >/= 9.0 gm/dL b). Platelet count >/= 100,000/mm^3 c). Absolute Neutrophil Count >/= 1,500/mm^3 d). INR </= 1.2 e). Cr </= 1.5 mg/dL f). AST and ALT tests </= 2.5 X ULN
12) If female and of childbearing potential, the subject must use appropriate birth control (abstinence, barrier methods, oral contraceptives, and/or intrauterine devices) during the entire duration of the study; or the female subject must be surgically sterile (with documentation in the subject's medical records).
13) Male subjects must use effective contraception (vasectomy or barrier methods, or surgical sterilization or post-menopausal status of partner) during the study and for at least 3 months following the last dose of MPC-6827. |