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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00250887
First received: November 4, 2005
Last updated: October 22, 2007
Last verified: October 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study of the Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00250887     History of Changes
Other Study ID Numbers: 1839IL/0526
Study First Received: November 4, 2005
Last Updated: October 22, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
recurrent Glioblastoma, Gefitinib

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on October 21, 2014