Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme
Eligibility Criteria
- 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
- 1. Have a carmustine implant (e.g., Gliadel® Wafer) 2. Have uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg for more than 1 week) 3. 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) 4. Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution 5. Have an increasing steroid requirement, indicative of a rapidly progressive disease 6. Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 2 7. Have had prior cranial radiotherapy 8. Have history of stroke and/or transient ischemic attack within 2 years of screening 9. Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening 10. Be pregnant or breast feeding 11. Have a history of hypersensitivity reaction to Cremophor® EL 12. Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
