Newly Diagnosed Glioblastoma Multiforme and Unmethylated MGMT – CORE Study

CILENIGITIDE IN SUBJECTS WITH NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME AND UNMETHYLATED MGMT GENE PROMOTER (#22908)

Cilengitide in subjects with newly diagnosed glioblastoma multiforme and unmethylated MGMT gene promoter--a multicenter, open-label Phase II study, investigating two cilengtide regimens in combination with standard treatment temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy. [The CORE study](#22908)

• Newly diagnosed histologically proven supratentorial GBMThe histological diagnosis must be obtained from a neurosurgical resection of the tumor or by an open biopsy (stereotactic biopsy not allowed).
• Proven unmethylated MGMT gene promoter status
• Available post-operative Gd-MRI performed within <48 hours after surgery 

Cilengitide is an experimental drug that is being tested to see if it will extend progression free survival (PFS). Prior studies have suggested that cilengitide might cut off the blood supply to tumors, which may prevent tumor growth.  The primary objective of this study is to investigate the overall survival time in subjects receiving 2 different regimens of 2000 mg of cilengitide in combination with radiation therapy and temozolomide standard therapy.

Cilengitide is a cyclized pentapeptide that is being developed as an alpha-v-beta-3 integrin  (αvβ3)/alpha-v-beta-5 integrin (αvβ5) receptor antagonist  in several oncological settings.

Surasak Phuphanich, MD, FAAN
Director, Neuro-oncology Program
phuphanich@cshs.orG
Phone: (310) 423-8100

Christy Davis, RN
christy.davis2@cshs.org
Phone: (310) 423-0022