Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
This study has been terminated.
(No accrual)
Sponsor:
University of Cincinnati
Collaborator:
Eisai Inc.
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00984438
First received: September 24, 2009
Last updated: August 23, 2010
Last verified: August 2010
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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: | Margie Gerena-Lewis, MD, Principal Investigator, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00984438 History of Changes |
| Other Study ID Numbers: | 08081101 |
| Study First Received: | September 24, 2009 |
| Last Updated: | August 23, 2010 |
| 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 May 21, 2013