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Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies

This study is currently recruiting participants.
Verified January 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897663
First received: May 9, 2009
Last updated: January 16, 2013
Last verified: January 2013
History of Changes

May 9, 2009
January 16, 2013
November 2006
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Molecular characteristics that predict for overall survival and progression-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00897663 on ClinicalTrials.gov Archive Site
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Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies
Optimizing EGFR Inhibitor-Based Therapies for GBM

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma multiforme to identify biomarkers that may improve the selection of patients for epidermal growth factor receptor inhibitor therapies.

OBJECTIVES:

Primary

  • Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with erlotinib hydrochloride, temozolomide, and radiotherapy on clinical trial NCCTG-N0177.

Secondary

  • Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with gefitinib after radiotherapy on clinical trial NCCTG-N0074.

OUTLINE: This is a multicenter study.

Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. Biological markers include epidermal growth factor expression, vIII mutant p53 gene, P-AKT, p7056k, S6, 4EBP1, STAT-3, PLC-g, Erk, ErbB2, ErbB3, ErbB4, platelet-derived growth factor receptor, IGF1R, interleukin-6, FADD, and MGMT.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Observational
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Brain and Central Nervous System Tumors
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunohistochemistry staining method
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
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DISEASE CHARACTERISTICS:

  • Enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074
  • Must have appropriate archived clinical specimens

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
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United States
 
NCT00897663
CDR0000527337, NCCTG-N0477
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Jann N. Sarkaria, MD Mayo Clinic
Investigator: Paul D. Brown, MD Mayo Clinic
Investigator: Joon H. Uhm, MD Mayo Clinic
Investigator: Jan C. Buckner, MD Mayo Clinic
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP