Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Gliobl… (NCT00689221) | Clinical Trial Compass
CompletedPhase 3
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status
United States, Germany545 participantsStarted 2008-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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)
What they're measuring
1
Overall Survival (OS) Time
Timeframe: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)
✓. Other protocol defined inclusion criteria could apply
Exclusion criteria
✕. 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