Multi-national, Open-label, Active-controlled, Randomized Dose-finding Study to Evaluate Efficacy of 2 Doses of AP 12009 in Recurrent Glioma, Administered Intratumorally as Continuous High-flow Microperfusion Over 7 Days Every Other Week
The purpose of this study is to compare the safety and efficacy of two doses of AP 12009 and
standard chemotherapy in adult patients with recurrent high-grade glioma (anaplastic
astrocytoma [AA], WHO grade III; or glioblastoma [GBM], WHO grade IV). AP 12009 is a
phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human transforming
growth factor-beta2 (TGF-beta2). The growth factor TGF-beta plays a key role in malignant
progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis
and escape from immunosurveillance. It has been shown that in a number of tumor types the
degree of TGF-beta production strongly correlates with tumor grade and stage. In patients
with high-grade glioma, the TGF-beta2 overexpression is associated with disease stage,
clinical prognosis and the immunodeficient state of the patients.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate of two AP 12009 dose groups and control group assessed by the evaluation of tumor size on brain MRI scans
No
Ulrich Bogdahn, MD
Principal Investigator
University of Regensburg, Dept. of Neurology, Germany
Austria: Federal Ministry for Health and Women
AP 12009-G004
NCT00431561
April 2003
March 2009
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