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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Recurrent Glioblastoma

Keywords

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recurrent Glioblastoma, Gefitinib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitnib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* enzyme inducing antiepileptic drugs
* pregnancy or breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Silvia Hofer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Locations

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University Hospital Zürich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED

PMID: 21471286 (View on PubMed)

Other Identifiers

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1839IL/0526

Identifier Type: -

Identifier Source: org_study_id