Overview

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

Summary

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

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
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.
gene expression analysis
microarray analysis
protein expression analysis
diagnostic laboratory biomarker analysis
immunohistochemistry staining method

Primary Outcomes

Measure
Molecular characteristics that predict for overall survival and progression-free survival
time frame: Up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.