Glioblastoma Multiforme
Conditions
Keywords
Glioblastoma, Brain Neoplasms, Recurrence
Brief summary
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
Interventions
DRUGAzixa
3.3 mg/m2 of Azixa administered by intravenous infusion over 2 hours once weekly for 3 consecutive weeks every 4 weeks (1 cycle = 4 weeks)
Sponsors
Myrexis Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have histologically proven malignant Glioblastoma Multiforme in first or second relapse * Have failed prior Fractionated External Beam Cranial Irradiation or IMRT * Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy * Have a Karnofsky performance status of ≥ 60 * Have adequate bone marrow function, liver function, and renal function before starting therapy
Exclusion criteria
* Have had more than two relapses * Have had radiosurgery * Have a cardiac ejection fraction \< 50% by MUGA or ECHO * Have Troponin-I elevated above the normal range * Have an increasing steroid requirement * Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage * Have active stroke and/or transient ischemic attack not optimally managed * Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension) * Be pregnant or breast feeding * Have had prior hypersensitivity reaction to Cremophor EL * Be HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the progression-free survival (PFS) rate | Six 28-day cycles from start of therapy |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 36 months |
| Overall response rate | 18 months |
Countries
United States
Outcome results
None listed