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

Primary Purpose

Recurrent Glioblastoma

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Gefitnib

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring recurrent Glioblastoma, Gefitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: recurrent glioblastoma informed consent reoperation planned fresh frozen sample obtainable Exclusion Criteria: enzyme inducing antiepileptic drugs pregnancy or breast feeding

Sites / Locations

University Hospital Zürich

Outcomes

Primary Outcome Measures

molecular signature of EGFR responsiveness to ZD1839

Secondary Outcome Measures

PFS

Full Information

NCT ID

NCT00250887

First Posted

November 4, 2005

Last Updated

October 22, 2007

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT00250887

Brief Title

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

Official Title

A Phase II Open Label Study of the Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma

Keywords

recurrent Glioblastoma, Gefitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gefitnib

Primary Outcome Measure Information:

Title

molecular signature of EGFR responsiveness to ZD1839

Secondary Outcome Measure Information:

Title

PFS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: recurrent glioblastoma informed consent reoperation planned fresh frozen sample obtainable Exclusion Criteria: enzyme inducing antiepileptic drugs pregnancy or breast feeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Silvia Hofer, MD

Organizational Affiliation

University Hospital, Zürich

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

21471286

Citation

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.

Results Reference

derived

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

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