Ph II Cilengitide Plus Bevacizumab for Recurrent Glioblastoma (GBM)
The goal of this clinical research study is to learn if cilengitide given in combination with bevacizumab can help to control glioblastoma. The safety of this drug combination will also be studied.
Cilengitide is designed to block the flow of blood to cancer cells, which may help to slow or block the growth of cancer.
Bevacizumab is designed to block the growth of new blood vessels, which may help to slow or block the growth of cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Cilengitide Plus Bevacizumab in Patients With Recurrent Glioblastoma|
- Progression-Free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Primary goal is to assess efficacy of administering cilengitide with bevacizumab for treatment of patients with recurrent gliomas who are bevacizumab-naïve. Study is designed to have adequate power to compare the efficacy of the experimental regimen to a historical benchmark. Basis for assessment is proportion of patients who have survived 6 months without disease progression (PFS-6).
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Cilengitide + Bevacizumab
Cilengitide administered intravenously at 2000 mg twice weekly, while Bevacizumab administered intravenously at 10 mg/kg every other week. Each cycle of therapy will be 4 weeks long.
2000 mg by vein twice weekly of each 28 day cycle.
Other Name: EMD 121974Drug: Bevacizumab
10 mg/kg by vein on Days 1 and 15 of each 28 day cycle.
Other Names:Behavioral: Questionnaire
Completion of MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) at baseline, Day 1 of cycle 2, and at end of treatment visit. Questionnaire should take about 5 minutes to complete.
Other Name: Survey
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01782976
|Principal Investigator:||Mark R. Gilbert, MD,BS||UT MD Anderson Cancer Center|