A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme
This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Temozolomide & Radiation Therapy
- drug : Verubulin
Phase: Phase 2
Ages Eligible For Study:
1. Have histologically proven, newly diagnosed glioblastoma multiforme 2. Age ? 18 years and < 70 years 3. Have an ECOG performance score of 0, 1, or 2, or KPS ? 70 4. Have adequate bone marrow function , liver function, and kidney function before starting therapy 5. Begin study therapy no more than 6 weeks after surgery or biopsy 6. Subjects that have had surgery must have an MRI ? 72 hours after surgery