Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.

Key facts

Study ID

NCT00635557

Run by

Myrexis Inc.

People needed

30

Starts

2008-03-01

Expected to finish

2011-08-01

Last updated by the study team

2011-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
• Prior treatment with radiotherapy and temozolomide
• Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
• Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
• Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2
• If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

You may not qualify if…

• Hypersensitivity to Cremophor EL
• Have evidence of current/active intratumor hemorrhage by MRI
• Have greater than second relapse
• Have had prior treatment with platinum-based chemotherapy
• Have cardiovascular disease
• Have cerebrovascular disease
• Have uncontrolled hypertension
• Have a cardiac ejection fraction < 50%
• Have Troponin-I elevated above the normal range

Where it is running

• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• Emory University — Atlanta, Georgia, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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