Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
Overview
- Phase
- Phase 1
- Intervention
- Irinotecan
- Conditions
- Glioblastoma Multiforme
- Sponsor
- University of Cincinnati
- Locations
- 1
- Primary Endpoint
- To assess disease free survival
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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 removed by brain surgery.
The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
Intervention: Irinotecan
BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
Intervention: Bevacizumab
BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
Intervention: BCNU Wafer
Outcomes
Primary Outcomes
To assess disease free survival
Time Frame: 6 and 12 months