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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00984438
• Other study ID #: 08081101
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• BCNU Wafer
Implantable during surgical resection into the tumor bed
• Irinotecan
IV every 2 weeks for up to one year
• Bevacizumab
IV every 2 weeks for up to one year

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess disease free survival		6 and 12 months