Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Eisai Inc.
• Treatments: Bevacizumab; Carmustine; Irinotecan

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