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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT00984438
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCNU Wafer — DRUG
    Implantable during surgical resection into the tumor bed
  • Irinotecan — DRUG
    IV every 2 weeks for up to one year
  • Bevacizumab — DRUG
    IV every 2 weeks for up to one year

Study Details

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.

Key Dates

Start date
Jun 30, 2009
Status verified
Jun 2013
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BCNU wafter followed by chemotherapy
    Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year

Primary Outcome Measure

To assess disease free survival [ Time Frame: 6 and 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45219-

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By research site
University of Cincinnati· Cincinnati, OH

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