Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies
This trial is active, not recruiting.
|Condition||brain and central nervous system tumors|
|Treatments||gene expression analysis, microarray analysis, protein expression analysis, diagnostic laboratory biomarker analysis, immunohistochemistry staining method|
|Sponsor||Alliance for Clinical Trials in Oncology|
|Collaborator||National Cancer Institute (NCI)|
|Start date||November 2006|
|End date||January 2100|
|Trial size||56 participants|
|Trial identifier||NCT00897663, CDR0000527337, N0477, NCCTG-N0477, NCI-2009-00645|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsdale, AZ||Mayo Clinic Scottsdale||no longer recruiting|
|Jacksonville, FL||Mayo Clinic - Jacksonville||no longer recruiting|
|Sioux City, IA||Siouxland Hematology-Oncology Associates, LLP||no longer recruiting|
|Sioux City, IA||Mercy Medical Center - Sioux City||no longer recruiting|
|Sioux City, IA||St. Luke's Regional Medical Center||no longer recruiting|
|Rochester, MN||Mayo Clinic Cancer Center||no longer recruiting|
|Bismarck, NC||Medcenter One Hospital Cancer Care Center||no longer recruiting|
|Bismarck, NC||Mid Dakota Clinic, PC||no longer recruiting|
|Bismarck, NC||St. Alexius Medical Center Cancer Center||no longer recruiting|
|Rapid City, SD||Rapid City Regional Hospital||no longer recruiting|
Molecular characteristics that predict for overall survival and progression-free survival
time frame: Up to 24 months
Male or female participants at least 18 years old.
All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.
|Official title||Optimizing EGFR Inhibitor-Based Therapies for GBM|
|Description||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.|
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