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

Trial ID or NCT#

NCT01285414

Status

not recruiting iconNOT 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

Ages Eligible for Study: 18 Years to 69 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Have histologically proven, newly diagnosed glioblastoma multiforme2. Age ≥ 18 years and \< 70 years3. Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 704. Have adequate bone marrow function , liver function, and kidney function before starting therapy5. Begin study therapy no more than 6 weeks after surgery or biopsy6. Subjects that have had surgery must have an MRI ≤ 72 hours after surgery
Exclusion Criteria:
  1. 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 institution5. Have an increasing steroid requirement, indicative of a rapidly progressive disease6. Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 27. Have had prior cranial radiotherapy8. Have history of stroke and/or transient ischemic attack within 2 years of screening9. Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening10. Be pregnant or breast feeding11. Have a history of hypersensitivity reaction to Cremophor® EL12. Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)
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Investigator(s)

Lawrence Recht, MD
Lawrence Recht, MD
Neuro-oncologist
Professor of Neurology and Neurological Sciences (Adult Neurology) and, by courtesy, of Neurosurgery

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov