Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status
| Status: | Archived |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2008 |
| End Date: | June 2014 |
Cilengitide in Subjects With Newly Diagnosed Glioblastoma Multiforme and Unmethylated MGMT Gene Promoter - a Multicenter, Open-label Phase II Study, Investigating Two Cilengitide Regimens in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy).
CORE is a Phase II clinical trial in newly diagnosed glioblastoma multiforme (GBM) in
patients with an unmethylated promoter of the methylguanine-DNA methyltransferase (MGMT)
gene in the tumor tissue.
The MGMT gene promoter is a section of DNA that acts as a controlling element for a
specific NDA product (MGMT). Methylation of the MGMT gene promoter has been found to appear
to be a predictive marker for benefit from temozolomide (TMZ) treatment.
In a safety run-in period in dedicated study centers the safety and tolerability of
Cilengitide given as an intense treatment in combination with the first part of standard
therapy will be assessed. Thereafter the trial will investigate the overall survival and
progression-free survival in patients receiving two different regimens of Cilengitide in
combination with standard treatment versus standard treatment alone.
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