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

This study has been withdrawn prior to enrollment.
(No accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984438
First Posted: September 25, 2009
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
University of Cincinnati
  Purpose

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.


Condition Intervention Phase
Glioblastoma Multiforme Drug: BCNU Wafer Drug: Irinotecan Drug: Bevacizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • To assess disease free survival [ Time Frame: 6 and 12 months ]

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984438


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Eisai Inc.
Investigators
Principal Investigator: Margie Gerena-Lewis, MD University of Cincinnati
  More Information

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00984438     History of Changes
Other Study ID Numbers: 08081101
First Submitted: September 24, 2009
First Posted: September 25, 2009
Last Update Posted: June 27, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Irinotecan
Carmustine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents