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
Lawrence Recht, MD

Professor of Neurology (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

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