Status:
WITHDRAWN
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Eisai Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be ...
Eligibility Criteria
Inclusion
- Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted.
- Must have had prior treatment with standard doses of Temodar
- KPS \>50; ECOG \<3
- Predicted life expectancy of \> 3 months
- Study entry must be within 5 weeks of surgical resection
Exclusion
- Prior exposure to VEGF inhibitors or Irinotecan
- Intracranial bleed as defined by CT or MRI less than 6 months prior to entry
- GI bleed less than 6 months prior to entry
- Uncontrolled concurrent illness that would limit compliance with study requirements
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00984438
Start Date
June 1 2009
End Date
June 1 2010
Last Update
November 25 2019
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219