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

University of Cincinnati

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Glioblastoma Multiforme

Treatments

Drug: BCNU Wafer

Drug: Irinotecan

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00984438

08081101

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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