Molecular Signatures of HNSCC in Response to Targeted Therapies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Enrollment
- 58
- Locations
- 3
- Primary Endpoint
- Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how will patients respond to treatment.
PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.
Detailed Description
OBJECTIVES: * To identify 100 patients from the Head and Neck Tumor Tissue Repository and Clinical Database treated with cetuximab monotherapy or cetuximab-containing combination therapy as a standard of care for recurrent and/or metastatic head and neck squamous cell carcinoma at Vanderbilt University Medical Center. * To assay the diversity of gene and protein expression patterns seen in these patients. * To identify predictive patterns associated with treatment response and survival of these patients by correlating the laboratory data with clinical data. OUTLINE: Tumor tissue specimens and clinical data are obtained from the Head and Neck Tumor Tissue Repository and Clinical Database protocol VU-VICC-HN-0356. Specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by DNA microarray, tissue microarray, reverse transcriptase-PCR, and mass spectroscopy.
Investigators
Barbara Murphy, MD
Professor of Medicine, Medical Oncologist
Vanderbilt-Ingram Cancer Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival
Time Frame: upon collection of final patient data
Identification of 100 patients from the Head and Neck (H&N) Tumor Tissue Repository and Clinical Database treated with cetuximab or cetuximab-containing combination therapy as a standard of care
Time Frame: approximately three years from enrollment of first patient
Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients
Time Frame: upon colleciton of final patient data