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This study has been withdrawn prior to enrollment.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:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00984438
First received: September 24, 2009
Last updated: June 26, 2013
Last verified: June 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00984438     History of Changes
Other Study ID Numbers: 08081101
Study First Received: September 24, 2009
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

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
Carmustine
Irinotecan
Bevacizumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 21, 2014