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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BCNU wafter followed by chemotherapy

Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year

Group Type EXPERIMENTAL

BCNU Wafer

Intervention Type DRUG

Implantable during surgical resection into the tumor bed

Irinotecan

Intervention Type DRUG

IV every 2 weeks for up to one year

Bevacizumab

Intervention Type DRUG

IV every 2 weeks for up to one year

Interventions

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BCNU Wafer

Implantable during surgical resection into the tumor bed

Intervention Type DRUG

Irinotecan

IV every 2 weeks for up to one year

Intervention Type DRUG

Bevacizumab

IV every 2 weeks for up to one year

Intervention Type DRUG

Other Intervention Names

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Gliadel Wafer CPT-11 Avastin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No