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Sponsors and Collaborators: |
Rigshospitalet, Denmark Aalborg Hospital Odense University Hospital |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00463073 |
Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas. In addition, 40-50 % of GBM have EGFR amplification/mutation making the EGFR an additional target. By combing cetuximab, with irinotecan and bevacizumab, one would expect further response, than irinotecan and bevacizumab alone. In addition, recurrent gliomas have an extremely poor prognosis, so innovative therapies are needed.
Condition | Intervention | Phase |
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Malignant Gliomas |
Drug: Cetuximab Drug: Bevacizumab Drug: Irinotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial With Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas and Progression After Radiation Therapy and Temozolamide |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Denmark | |
Odense University Hospital | |
Odense, Denmark, 5000 | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
Aalborg University Hospital | |
Aalborg, Denmark, 9000 |
Principal Investigator: | Ulrik Lassen, MD., PH.D. | Rigshospitalet, Dept. of Oncology |
Study ID Numbers: | CBI-GBM-01 |
Study First Received: | April 19, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00463073 |
Health Authority: | Denmark: Danish Medicines Agency |
Progressive primary Glioblastoma multiforme |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal Cetuximab |
Irinotecan Disease Progression Neuroepithelioma Bevacizumab Glioma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Enzyme Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic |