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

University of Cincinnati

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Glioblastoma Multiforme

Interventions

BCNU WaferDRUG

Implantable during surgical resection into the tumor bed

IrinotecanDRUG

IV every 2 weeks for up to one year

BevacizumabDRUG

IV every 2 weeks for up to one year

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

To assess disease free survival

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

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