NCT00250887

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 23, 2007

Status Verified

October 1, 2007

First QC Date

November 4, 2005

Last Update Submit

October 22, 2007

Conditions

Recurrent Glioblastoma

Keywords

recurrent Glioblastoma, Gefitinib

Outcome Measures

Primary Outcomes (1)

  • molecular signature of EGFR responsiveness to ZD1839

Secondary Outcomes (1)

  • PFS

Interventions

GefitnibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recurrent glioblastoma
  • informed consent
  • reoperation planned
  • fresh frozen sample obtainable

You may not qualify if:

  • enzyme inducing antiepileptic drugs
  • pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Hegi ME, Diserens AC, Bady P, Kamoshima Y, Kouwenhoven MC, Delorenzi M, Lambiv WL, Hamou MF, Matter MS, Koch A, Heppner FL, Yonekawa Y, Merlo A, Frei K, Mariani L, Hofer S. Pathway analysis of glioblastoma tissue after preoperative treatment with the EGFR tyrosine kinase inhibitor gefitinib--a phase II trial. Mol Cancer Ther. 2011 Jun;10(6):1102-12. doi: 10.1158/1535-7163.MCT-11-0048. Epub 2011 Apr 6.

    PMID: 21471286DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Silvia Hofer, MD

    University Hospital, Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 8, 2005

Study Start

July 1, 2005

Study Completion

May 1, 2007

Last Updated

October 23, 2007

Record last verified: 2007-10

Locations

CH(1)