Glioblastoma Multiforme
Conditions
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.
Interventions
DRUGBCNU Wafer
Implantable during surgical resection into the tumor bed
DRUGIrinotecan
IV every 2 weeks for up to one year
DRUGBevacizumab
IV every 2 weeks for up to one year
Sponsors
Eisai Inc.
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess disease free survival | 6 and 12 months |
Countries
United States
Outcome results
None listed