Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00250887

Purpose

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
Recurrent Glioblastoma	Drug: Gefitnib	Phase II

Drug Information available for: ZD1839

U.S. FDA Resources

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

Further study details as provided by University of Zurich:

Primary Outcome Measures:

molecular signature of EGFR responsiveness to ZD1839

Secondary Outcome Measures:

PFS

Enrollment:	22
Study Start Date:	July 2005
Study Completion Date:	May 2007

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

recurrent glioblastoma
informed consent
reoperation planned
fresh frozen sample obtainable

Exclusion Criteria:

enzyme inducing antiepileptic drugs
pregnancy or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250887

Locations

Switzerland
University Hospital Zürich
Zürich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:	Silvia Hofer, MD	University Hospital, Zürich
Principal Investigator:	Silvia Hofer, MD	University Hospital, Zürich
Principal Investigator:	Silvia Hofer, MD	University Hospital, Zürich

More Information

Study ID Numbers:	1839IL/0526
Study First Received:	November 4, 2005
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00250887
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

recurrent Glioblastoma, Gefitinib

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioma
Gefitinib
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes

Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009