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Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
Not Recruiting
Trial ID: NCT00892931
Purpose
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
Official Title
Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme
Stanford Investigator(s)
Lawrence Recht, MD
Professor of Neurology and Neurological Sciences (Adult Neurology) and, by courtesy, of Neurosurgery
Eligibility
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
Intervention(s):
drug: Azixa
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061