Status:
COMPLETED
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
European Organisation for Research and Treatment of Cancer - EORTC
Merck KGaA, Darmstadt, Germany
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 newl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT00689221
Start Date
September 1 2008
End Date
August 1 2013
Last Update
November 4 2014
Active Locations (2)
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1
Please Contact U.S. Medical Information Located in
Rockland, Massachusetts, United States
2
Please Contact the Merck KGaA Communication Center Located in
Darmstadt, Germany