Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme (NCT01285414)

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)

MPC-6827 for Recurrent Glioblastoma Multiforme (NCT00892931)

Inclusion Criteria:

• Have histologically proven malignant Glioblastoma Multiforme in first or second relapse
• Have failed prior Fractionated External Beam Cranial Irradiation or IMRT
• Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin^® therapy
• Have a Karnofsky performance status of ≥ 60
• Have adequate bone marrow function, liver function, and renal function before starting therapy

Exclusion Criteria:

• Have had more than two relapses
• Have had radiosurgery
• Have a cardiac ejection fraction < 50% by MUGA or ECHO
• Have Troponin-I elevated above the normal range
• Have an increasing steroid requirement
• Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage
• Have active stroke and/or transient ischemic attack not optimally managed
• Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension)
• Be pregnant or breast feeding
• Have had prior hypersensitivity reaction to Cremophor EL^®
• Be HIV positive