Adult Gliosarcoma Clinical Trial
Official title:
Phase II Single Arm Trial of VEGF Trap in Patients With Recurrent Temozolomide-Resistant Malignant Gliomas
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. Determine the therapeutic efficacy of VEGF Trap in patients with temozolomide-resistant
malignant gliomas at first recurrence as measured by 6-month progression-free survival
(PFS).
II. Determine the safety profile of VEGF Trap in these patients.
SECONDARY OBJECTIVES:
I. Determine the efficacy of this regimen as measured by radiographic response, PFS, time to
progression, and overall survival.
II. Characterize the single-dose and repeated-dose pharmacokinetic profiles of VEGF Trap in
these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histology
(glioblastoma vs anaplastic glioma).
Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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