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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myrexis Inc.
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion 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

Exclusion Criteria:

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)