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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT00984438

Run by

University of Cincinnati

People needed

0

Starts

2009-06-01

Expected to finish

2010-06-01

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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