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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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