Phase I/II Trial of Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab for Treatment of Newly Diagnosed Glioblastoma Multiforme
The experimental aspects of this experimental plan will include:
1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol
25%; delivered IA, 10 mL over 2 minutes) in order to disrupt the blood brain barrier.
This technique has been used in several thousand subjects in previous studies for the
IA delivery of chemotherapy for malignant glioma.
2. Subjects will then be treated with repeated intraarterial delivery (SIACI) of
Bevacizumab. Each subject will receive one dose of IA Bevacizumab on day 30, followed
by chemoradiation. SIACI of Bevacizumab will be repeated every three months for a total
of 3 infusions.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Six-month progression-free survival (PFS)
Six-month progression-free survival (PFS)and overall survival (OS) will be assessed by Kaplan-Meier survival analysis, assuming adequate follow-up time. PFS will be measured from the date of the first dose of SIACI Bevacizumab to the date of progression.
John Boockvar, MD
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Cornell Medical College||New York, New York 10021|