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

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ClinicalTrials.gov Identifier: NCT00984438
Recruitment Status : Withdrawn (No accrual)
First Posted : September 25, 2009
Last Update Posted : June 27, 2013
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
University of Cincinnati

Tracking Information
First Submitted Date  ICMJE September 24, 2009
First Posted Date  ICMJE September 25, 2009
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
To assess disease free survival [ Time Frame: 6 and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00984438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
Official Title  ICMJE Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: BCNU Wafer
    Implantable during surgical resection into the tumor bed
    Other Name: Gliadel Wafer
  • Drug: Irinotecan
    IV every 2 weeks for up to one year
    Other Name: CPT-11
  • Drug: Bevacizumab
    IV every 2 weeks for up to one year
    Other Name: Avastin
Study Arms  ICMJE Experimental: BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
Interventions:
  • Drug: BCNU Wafer
  • Drug: Irinotecan
  • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 23, 2010)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2009)
15
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984438
Other Study ID Numbers  ICMJE 08081101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Eisai Inc.
Investigators  ICMJE
Principal Investigator: Margie Gerena-Lewis, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP