Status:
UNKNOWN
Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
Lead Sponsor:
Myrexis Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 sepa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00635557
Start Date
March 1 2008
End Date
August 1 2011
Last Update
March 25 2011
Active Locations (5)
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1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
2
Emory University
Atlanta, Georgia, United States, 30322
3
Mt. Sinai School of Medicine
New York, New York, United States, 10029
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030