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

Phase 1

Withdrawn

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: BCNU Wafer; Drug: Irinotecan; Drug: Bevacizumab

• Registration Number: NCT00984438
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-06
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCNU wafter followed by chemotherapy	BCNU Wafer	Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
BCNU wafter followed by chemotherapy	Irinotecan	Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
BCNU wafter followed by chemotherapy	Bevacizumab	Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year

Primary Outcome Measures

Name	Time	Method
To assess disease free survival	6 and 12 months

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States