Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme

Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin

This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.

Inclusion Criteria:

• Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
• Prior treatment with radiotherapy and temozolomide
• Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
• Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
• Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2
• If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

Exclusion Criteria:

• Hypersensitivity to Cremophor EL
• Have evidence of current/active intratumor hemorrhage by MRI
• Have greater than second relapse
• Have had prior treatment with platinum-based chemotherapy
• Have cardiovascular disease
• Have cerebrovascular disease
• Have uncontrolled hypertension
• Have a cardiac ejection fraction < 50%
• Have Troponin-I elevated above the normal range