NCT00984438

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

Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	BCNU Wafer	Implantable during surgical resection into the tumor bed
DRUG	Irinotecan	IV every 2 weeks for up to one year
DRUG	Bevacizumab	IV every 2 weeks for up to one year

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-09-25
• Last updated: 2019-11-25

Locations

1 site across 1 country: United States