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Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

Thank you

Trial Information

Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess disease free survival

Outcome Time Frame:

6 and 12 months

Safety Issue:

No

Principal Investigator

Margie Gerena-Lewis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati

Authority:

United States: Institutional Review Board

Study ID:

08081101

NCT ID:

NCT00984438

Start Date:

June 2009

Completion Date:

June 2010

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma

Name

Location
University of Cincinnati Cincinnati, Ohio  45267-0502