Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme

Inclusion criteria

• Have histologically proven, newly diagnosed glioblastoma multiforme
• Age ≥ 18 years and < 70 years
• Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 70
• Have adequate bone marrow function , liver function, and kidney function before starting therapy
• Begin study therapy no more than 6 weeks after surgery or biopsy
• Subjects that have had surgery must have an MRI ≤ 72 hours after surgery

Exclusion criteria

• Have a carmustine implant (e.g., Gliadel® Wafer)
• Have uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg for more than 1 week)
• Have a left ventricular ejection fraction below the lower limit of the reference range for the institution, as measured by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
• Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution
• Have an increasing steroid requirement, indicative of a rapidly progressive disease
• Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 2
• Have had prior cranial radiotherapy
• Have history of stroke and/or transient ischemic attack within 2 years of screening
• Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening
• Be pregnant or breast feeding
• Have a history of hypersensitivity reaction to Cremophor® EL
• Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)