Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status

Completed · Phase 2

Conditions studied: Glioblastoma

In brief

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. The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to appear to be a predictive marker for benefit from temozolomide (TMZ) treatment. In a safety run-in period in dedicated study centers, the safety and tolerability of Cilengitide given as an intense treatment in combination with the first part of standard therapy will be assessed. Thereafter the trial will investigate the overall survival and progression-free survival in subjects receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone.

Key facts

Study ID: NCT00813943
Run by: EMD Serono
People needed: 265
Starts: 2009-03-01
Expected to finish: 2013-08-01
Last updated by the study team: 2017-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Please Contact U.S. Medical Information Located in — Rockland, Massachusetts, United States
Please Contact the Merck KGaA Communication Center Located in — Darmstadt, Germany

Full record on ClinicalTrials.gov

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