Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Center for Neurosciences, Tucson
Study ID
NCT00883298
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Glioblastoma Multiforme
  • Recurrent Gliosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 83 Years
Healthy Volunteers
Not accepted

Interventions

  • temozolomide and bevacizumab — DRUG
    oral temozolomide 100 mg/m2 days 1-5 \& 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 \& 5 every 28-day cycle

Study Details

Primary objective - to determine the 6-month progression free survival (PFS) of adult patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus (Avastin) bevacizumab. Secondary objectives - to determine radiographic response including specialized MRI sequences, safety and overall survival of adult patients with with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin). Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.

Key Dates

First listed
Apr 17, 2009
Start date
Apr 30, 2009
Status verified
Mar 2017
Primary completion
Dec 31, 2014
Completion
Dec 1, 2014

Study Design

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

Arms

  • Experimental: Open Label
    temozolomide plus bevacizumab administered as open label single arm treatment

Primary Outcome Measure

6-month progression-free survival. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for NeurosciencesTucsonArizona85718-

Find similar trials in Tucson, AZ

By research site
Center for Neurosciences· Tucson, AZ

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