Summary
In an initial step subjects with newly diagnosed GBM (suspected or already established diagnosis) will be offered to have their tumor centrally assessed for MGMT gene promoter methylation status. After giving specific written informed consent to this analysis, they will be formally registered and the tissue analyzed.
If a methylated MGMT gene promoter status and newly diagnosed GBM is confirmed during this procedure, subjects will be offered in a second step clinical trial participation. After giving a second written informed consent for study participation, subjects will be screened to determine their eligibility for the study according to defined medical criteria (inclusion and exclusion criteria). Eligible patients will subsequently be randomized in a 1:1 ratio to either cilengitide with standard treatment (Cilengitide plus TMZ/RTX?TMZ), referred to as the cilengitide group [Cil-TMZ/RTX], or standard treatment of TMZ/RTX?TMZ alone, referred to as the control group.
Subjects in the cilengitide group will be treated with 200 mg cilengitide (twice weekly, i.v.) in combination with standard therapy for 8 months, followed by a 10 month cilengitide maintenance treatment.
Subjects in the cilengitide group may continue receiving the drug after completion of 18 months of treatment, until occurrence of progressive disease or toxicity, or until withdrawal for any reason.
Subjects in the control group will receive standard therapy for 8 months (6 weeks of RTX + TMZ, followed by 6 four-week cycles of TMZ maintenance treatment). Treatment may stop earlier than planned due to occurrence of progressive disease or toxicity, or until withdrawal for any reason.
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