Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status

Completed · Phase 3

Conditions studied: Glioblastoma

In brief

CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue. The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.

Key facts

Study ID

NCT00689221

Run by

EMD Serono

People needed

545

Starts

2008-09-01

Expected to finish

2013-08-01

Last updated by the study team

2014-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed, paraffin-embedded block; stereotactic biopsy not allowed) must be available for MGMT status analysis and central pathology review
• Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV)
• Proven methylated MGMT gene promoter methylation status
• Available post-operative gadolinium-enhanced magnetic resonance imaging (Gd-MRI) performed within less than (<) 48 hours after surgery (in case it was not possible to obtain a Gd-MRI within <48 hours post surgery, a Gd-MRI is to be performed prior to randomization)
• Stable or decreasing dose of steroids for greater than or equal to (>=) 5 days prior to randomization
• Eastern Cooperative Oncology Group performance score (ECOG PS) of 0-1
• Meets 1 of the following recursive partitioning analysis (RPA) classifications: Class III (Age < 50 years and ECOG PS 0). Class IV (meeting one of the following criteria: a) Age < 50 years and ECOG PS 1 or b) Age >= 50 years, underwent prior partial or total tumor resection, mini mental state examination [MMSE] >= 27). Class V (meeting one of the following criteria: a) Age >= 50 years and underwent prior partial or total tumor resection, MMSE < 27 or b) Age >= 50 years and underwent prior tumor biopsy only)
• Other protocol defined inclusion criteria could apply

You may not qualify if…

• Prior chemotherapy within the last 5 years
• Prior RTX of the head
• Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide
• Prior systemic antiangiogenic therapy
• Placement of Gliadel® wafer at surgery
• Inability to undergo Gd-MRI.
• Planned surgery for other diseases
• History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment
• History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for >= 5 years are eligible for this study
• History of coagulation disorder associated with bleeding or recurrent thrombotic events
• Clinically manifest myocardial insufficiency (New York Heart Association [NYHA] III, IV) or history of myocardial infarction during the past 6 months; uncontrolled arterial hypertension
• Other protocol defined exclusion criteria could apply

Where it is running

• Please Contact U.S. Medical Information Located in — Rockland, Massachusetts, United States
• Please Contact the Merck KGaA Communication Center Located in — Darmstadt, Germany

Full record on ClinicalTrials.gov

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