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

Primary Purpose

Glioblastoma Multiforme

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BCNU Wafer
Irinotecan
Bevacizumab
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BCNU wafter followed by chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

To assess disease free survival

Secondary Outcome Measures

Full Information

First Posted
September 24, 2009
Last Updated
November 21, 2019
Sponsor
University of Cincinnati
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00984438
Brief Title
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
Official Title
Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No accrual
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cincinnati
Collaborators
Eisai Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCNU wafter followed by chemotherapy
Arm Type
Experimental
Arm Description
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
Intervention Type
Drug
Intervention Name(s)
BCNU Wafer
Other Intervention Name(s)
Gliadel Wafer
Intervention Description
Implantable during surgical resection into the tumor bed
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11
Intervention Description
IV every 2 weeks for up to one year
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
IV every 2 weeks for up to one year
Primary Outcome Measure Information:
Title
To assess disease free survival
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margie Gerena-Lewis, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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