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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00250887 |
This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy). Gefitinib is a specific inhibitor of the epidermal growth factor receptor (EGFR). EGFR is elevated in more than 50% of malignant gliomas. At recurrence, secondary surgery and pre- and postoperative Gefitinib is offered to patients in good performance status. Clinical outcome of patients and correlation to translational research will be evaluated.
Condition | Intervention | Phase |
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Recurrent Glioblastoma |
Drug: Gefitnib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Open Label Study of the Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research |
Enrollment: | 22 |
Study Start Date: | July 2005 |
Study Completion Date: | May 2007 |
Glioblastoma (GBM) patients who relapse and are in good performance status, without serious neurological deficits are offered secondary surgery and participation in the trial. Eligible patients must have had standard treatment including primary surgery, radiation therapy and at least a first line chemotherapy. Patients on cytochrome P450 isoenzyme CYP3A4-inducing antiepileptic drugs (EIAE) are excluded due to ensuing interactions of these drugs with gefitinib metabolism, reducing systemic availability. After giving written informed consent, patients receive gefitinib 500 mg daily starting at least 5 days prior to re-operation, allowing a steady state condition.Treatment continues until tumor progression or occurrence of intolerable side effects.The specimens collected at surgery will undergo translational research, aiming to correlate drug accumulation and molecular signatures of GBM samples with clinical outcome.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
University Hospital Zürich | |
Zürich, Switzerland, 8091 |
Principal Investigator: | Silvia Hofer, MD | University Hospital, Zürich |
Principal Investigator: | Silvia Hofer, MD | University Hospital, Zürich |
Principal Investigator: | Silvia Hofer, MD | University Hospital, Zürich |
Study ID Numbers: | 1839IL/0526 |
Study First Received: | November 4, 2005 |
Last Updated: | October 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00250887 |
Health Authority: | Switzerland: Swissmedic |
recurrent Glioblastoma, Gefitinib |
Neuroectodermal Tumors Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Gefitinib Recurrence Neoplasms, Glandular and Epithelial |
Disease Attributes Neoplasms Pathologic Processes |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |