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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Optimizing EGFR Inhibitor-Based Therapies for GBM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897663
• Other study ID #: N0477
• Secondary ID: NCCTG-N0477CDR00
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: January 22, 2018
• Start date: November 2006
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older
• Eligibility: All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Genetic:
• gene expression analysis

• microarray analysis

• protein expression analysis

Other:
• diagnostic laboratory biomarker analysis

• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular characteristics that predict for overall survival and progression-free survival		Up to 24 months