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


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Glioblastoma

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Trial Information

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


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.


Inclusion Criteria:



- recurrent glioblastoma

- informed consent

- reoperation planned

- fresh frozen sample obtainable

Exclusion Criteria:

- enzyme inducing antiepileptic drugs

- pregnancy or breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

molecular signature of EGFR responsiveness to ZD1839

Principal Investigator

Silvia Hofer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Z├╝rich

Authority:

Switzerland: Swissmedic

Study ID:

1839IL/0526

NCT ID:

NCT00250887

Start Date:

July 2005

Completion Date:

May 2007

Related Keywords:

  • Recurrent Glioblastoma
  • recurrent Glioblastoma, Gefitinib
  • Glioblastoma

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