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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00813943 |
CORE is a Phase II clinical trial in newly diagnosed glioblastoma multiforme (GBM) (a cancerous tumor in the brain) in patients with an unmethylated promoter of the methylguanine-DNA methyltransferase (MGMT) gene in the tumor tissue.
The MGMT gene promoter is a section of DNA that acts as a controlling element for a specific NDA product (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 patients receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone.
Condition | Intervention | Phase |
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Glioblastoma Multiforme |
Drug: Cilengitide Drug: Temozolomide & Radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Cilengitide in Subjects With Newly Diagnosed Glioblastoma Multiforme and Unmethylated MGMT Gene Promoter - a Multicenter, Open-Label Phase II Study, Investigating Two Cilengitide Regimens in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy). |
Estimated Enrollment: | 228 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Cilengitide
Cilengitide 2000mg i.v. twice weekly, Temozolomide & Radiotherapy
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2: Experimental |
Drug: Cilengitide
Cilengitide in general 2000mg i.v. twice weekly, however during combination with Temozolomide & Radiotherapy five times per week.
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3: Active Comparator |
Drug: Temozolomide & Radiotherapy
Temozolomide & Radiotherapy
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meets 1 of the following RPA classifications:
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:
Exclusion Criteria:
Responsible Party: | Merck KGaA ( Martin Picard, PhD ) |
Study ID Numbers: | EMD 121974-012 |
Study First Received: | December 22, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00813943 |
Health Authority: | United States: Food and Drug Administration |
Newly diagnosed Glioblastoma multiforme (GBM) (WHO Grade IV) |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |