Supratentorial Newly Diagnosed Inoperable Gliobastoma Clinical Trial
Official title:
A Multi-center, Open-label, Randomized, Controlled Phase I Trial to Investigate the Effects of Cilengitide (EMD 121974) Using Dynamic MR and FET-PET Imaging as a Pharmacodynamic Measure of Response in Subjects With Newly Diagnosed Glioblastoma
The main purpose of this clinical trial is to find out if cilengitide has an effect on brain
tumor cells but also particularly on the blood vessels supplying the tumor with nutrient and
oxygen in patients newly diagnosed with non-resectable (inoperable) glioblastoma.
In addition, this clinical trial will investigate if the addition of cilengitide in
combination with standard treatment prolongs life in patients with non-resectable
glioblastoma. Similarly, the duration of response of the cancer to this treatment and the
side effects of the therapy will be analyzed. Furthermore, additional data on how the body
deals with this substance will be collected (this is called pharmacokinetics or
pharmacokinetic (PK) analysis). In this clinical trial the investigators would also like to
learn more about the disease and the response to the experimental medication by measuring
certain "markers".
This imaging trial will investigate the biological effects of cilengitide monotherapy on the
tumor microvascular function and tumor viability in a homogenous non-pretreated subject
population with newly diagnosed Gliobastoma (GBM). The purpose of this clinical trial is to
study the effect that cilengitide may have on certain markers of cancer in your tumor and/or
blood and to learn if there are any disease-related markers that could help in predicting
how subjects respond to the administration of cilengitide.
The investigators anticipate that approximately 30 subjects will participate in this
clinical trial. The clinical trial will be conducted in approximately 4 medical centers in
the following countries: Germany, Poland, and Switzerland. The investigators anticipate the
clinical trial will last until the end of 2013. Your participation in the trial may last up
to 86 weeks.
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science