Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Trial ID or NCT#

NCT00892931

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

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