Status:
COMPLETED
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue. Th...
Eligibility Criteria
Inclusion
- Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization \[WHO\] Grade IV, including glioblastoma subtypes, for example, gliosarcoma). The histological diagnosis has to be obtained from a neurosurgical resection of the tumor or by an open biopsy (stereotactic biopsy is not allowed)
- Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed paraffin-embedded) must be available for MGMT gene promoter status analysis and central pathology review
- Proven unmethylated MGMT gene promoter status (that is, cut-off ratio less than (\<) 2 by means of applied test to determine MGMT gene promoter status)
- Males or females greater than or equal to (\>=) 18 years of age
- Interval of \>= 2 weeks but less than or equal to (=\<) 7 weeks after surgery or biopsy before first administration of study treatment
- Available post-operative gadolinium-enhanced magnetic resonance imaging (Gd-MRI) performed within \< 48 hours after surgery
- Stable or decreasing dose of steroids for \>= 5 days prior to randomization
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
- Has to meet 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 (except for low dose RTX for tinea capitis)
- Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide
- Prior systemic anti-angiogenic therapy
- Placement of Gliadel® wafer at surgery
- 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; or uncontrolled arterial hypertension
- Inability to undergo Gd-MRI
- Concurrent illness, including severe infection (for example, human immunodeficiency virus), which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety
- Subject is pregnant (positive serum beta human chorionic gonadotropin \[b-HCG\] test at screening) or is currently breast-feeding, anticipates becoming pregnant/impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessar, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment
- Current alcohol dependence or drug abuse
- Known hypersensitivity to the study treatment
- Legal incapacity or limited legal capacity
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
- Other protocol defined exclusion criteria could apply
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00813943
Start Date
March 1 2009
End Date
August 1 2013
Last Update
January 30 2017
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