Subjects with newly diagnosed glioblastoma, who have met all eligibility criteria for the CENTRIC study (EMD 121974-011 study, EudraCT 2007-004344-78) with the exception of NOT having a tumor with a methylated MGMT-promoter will be invited for participation in the present CeCil trial. Documentation of the MGMT promoter methylation status will be obtained from the test result from the screening phase of the Phase III CENTRIC study (EMD 121974-011). MedDRA version: 12.0 Level: LLT Classification
Conditions
Interventions
Trade Name: erbitux 5mg/ml
Pharmaceutical Form:
INN or Proposed INN: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Product Name: Cile
Sponsors
Prof Bart Neyns
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1For inclusion in the study, all of the following inclusion criteria must be fulfilled: 1. Written informed consent obtained before undergoing any study-related activities. 2. Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV, including glioblastoma subtypes, e.g. gliosarcoma). The histological diagnosis must be obtained from a neurosurgical resection of the tumor or by an open biopsy (patients who underwent only a stereotactic biopsy are not eligible). 3. Tumor tissue specimens from the glioblastoma surgery or open biopsy (FFPE block) must be available for MGMT gene promoter status analysis and central pathology review and must have been submitted as part of the screen procedure for the CENTRIC phase III study (Merck KGaA reference EMD 121974-011, EudraCT 2007-004344-78). 4. MGMT gene promoter status determined as NOT methylated during the screen procedure for the CENTRIC phase III study (i.e. cut-off ratio 5 days prior to randomization. 9. Eastern Cooperative Oncology Group performance score (ECOG PS) of 0-1. 10. Meets one of the following recursive partitioning analysis (RPA) classifications: • Class III (Age 1500/mm3. • Platelets >100,000/mm3. • Creatinin 10 g/dL. • Total bilirubin >1.5 x the ULN. • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are not eligible for this study, if they fulfill one or more of the following exclusion criteria: 1. Prior chemotherapy within the last 5 years. 2. Prior RT of the head. 3. Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of Cilengitide. 4. Prior systemic anti-angiogenic therapy. 5. Placement of Gliadel® wafer at surgery. 6. Planned surgery for other diseases (e.g. dental extraction). 7. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment. 8. 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. 9. History of coagulation disorder associated with bleeding or recurrent thrombotic events. 10. 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. 11. Inability to undergo Gd-MRI. 12. Concurrent illness, including severe dermatological conditions or infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety. 13. Subject is pregnant (positive serum beta human chorionic gonadotropin [?-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. 14. Current alcohol dependence or drug abuse. 15. Known hypersensitivity to the study treatment. 16. Legal incapacity or limited legal capacity. 17. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 18. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. 19. Treatment with prohibited concomitant medication as defined in Section 9.8.1 of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the treatment effect on the one-year overall survival rate for both study arms seperatly.;Primary end point(s): Primary endpoint: • 12 month overall survival rate (for each study arm seperatly) Secondary endpoints: • 6-, and 12-months progression-free survival (PFS) and overall survival (OS) • Median PFS and OS • Description of adverse events according to CTCAEv 3.0 ;Secondary Objective: - Evaluate treatment effect on progression-free survival and overall survival - Evaluate Median PFS and OS - Evaluate Safety and toxicity: an interim analysis will be made after the first 6 and 12 patients on each study arm have completed the first 7 weeks of the study treatment. A final analysis will be made for the total study population | — |
Countries
Belgium
Outcome results
None listed