Health Condition 1: null- Glioblastoma
Conditions
Interventions
Intervention1: Cilengitide, Temozolomide & Radiotherapy: Cilengitide 2000mg i.v. twice weekly, Temozolomide & Radiotherapy
Control Intervention1: Temozolomide &
Radiotherapy: Subjects in the control group will receive 6 weeks of radiotherapy (2 Gy a day, 5 days a wk) + oral temozolomide (75 mg/m2, daily) followed by 6 four week cycles of temozolomide mainten
Sponsors
Merck KGaA
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Tumor tissue specimens from the GBM 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 GBM (World Health Organization [WHO] Grade IV). Proven methylated MGMT gene promoter methylation status. Available post-operative Gd-MRI performed within Stable or decreasing dose of steroids for ≥5 days prior to randomization ECOG PS of 0-1. Meets 1 of the following RPA classifications:? Class III (Age less than 50 years and ECOG PS 0). Class IV (meeting one of the following criteria: a) Age less than 50 years and ECOG PS 1 or b) Age more than or equal to years, underwent prior partial or total tumor resection, MMSE more than or equal to 27).Class V (meeting one of the following criteria: a) Age more than or equal to years and underwent prior partial or total tumor resection, MMSE less than 27 or b) Age more than or equal to years and underwent prior tumor biopsy only).
Exclusion criteria
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 (e.g. dental extraction). 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 (NYHA III, IV) or history of myocardial infarction during the past 6 months. Uncontrolled arterial hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival timeTimepoint: various timepoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective is to investigate the Progression Free Survival (PFS)Timepoint: various time points | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Republic of Korea, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, United Kingdom, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt Ltd.
Outcome results
None listed