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 (Adult Neurology) and, by courtesy, of Neurosurgery

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov