DNA Analysis of Tumor Tissue Samples From Patients With Human Papilloma Virus-Associated Cancer of the Oropharynx
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
gene expression analysis
mutation analysis
polyacrylamide gel electrophoresis
polymerase chain reaction
protein expression analysis
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
immunologic technique
laboratory biomarker analysis
pharmacological study
Sponsored by
About this trial
This is an observational trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Undergoing operative procedures for biopsy and/or resection of squamous cell carcinoma (SCC) of the oropharynx
- Tumor tissue sample available from the Head and Neck Tissue Repository and Clinical Database of Vanderbilt University
- No tumors with human papilloma virus (HPV) DNA sequences but no expression of E6
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- Not specified
Sites / Locations
- Vanderbilt-Ingram Cancer Center - Cool Springs
- Vanderbilt-Ingram Cancer Center at Franklin
- Vanderbilt-Ingram Cancer Center
Outcomes
Primary Outcome Measures
PIK3CA expression and mutation and p110α amplification and expression in tumor tissue samples from patients with human papilloma virus positive (HPV+) and human papilloma virus negative (HPV-) squamous cell carcinoma (SCC) of the oropharynx
Proliferation and survival after PI3K inhibition in HPV(+) and HPV(-) oropharyngeal SCC cell lines and in HPV E6 and E7 expressing cells
Proliferation and survival after PI3K inhibition in short-term cultures of tumor tissues from patients with HPV(+) and HPV(-) primary SCC of the oropharynx
Secondary Outcome Measures
Full Information
NCT ID
NCT00897988
First Posted
May 9, 2009
Last Updated
March 10, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00897988
Brief Title
DNA Analysis of Tumor Tissue Samples From Patients With Human Papilloma Virus-Associated Cancer of the Oropharynx
Official Title
Effect of PI3K Inhibition in HPV-Associated HNSCC
Study Type
Observational
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at the DNA in tumor tissue samples from patients with human papilloma virus-associated cancer of the oropharynx.
Detailed Description
OBJECTIVES:
Analyze PIK3CA expression and mutation and p110α amplification and expression in tumor tissue samples from patients with human papilloma virus positive (HPV+) and human papilloma virus negative (HPV-) squamous cell carcinoma (SCC) of the oropharynx.
Determine proliferation and survival after PI3K inhibition in HPV(+) and HPV(-) oropharyngeal SCC cell lines and in HPV E6 and E7 expressing cells.
Determine proliferation and survival after PI3K inhibition in short-term cultures of tumor tissue samples from patients with HPV(+) and HPV(-) primary SCC of the oropharynx.
OUTLINE: Previously collected tumor tissue samples are analyzed for HPV DNA by PCR amplification and direct sequencing of PCR products; expression of E6 protein and relative expression of PIK3CA by qRT-PCR; amplification of PIK3CA by Southern blotting; mutation of PIK3CA; expression of p110α, phospho-AKT, total AKT, and FOXO1 by polyacrylamide gel electrophoresis (PAGE) and immunoblotting; and the effect of PI3K inhibition on cell cycle and apoptosis by flow cytometry. Pharmacological studies are performed on oropharyngeal squamous cell carcinoma cell lines and short-term cultures and HPV E6 and E7 expressing cells using LY 294002 in vitro to analyze response to PI3K inhibition. Results of response to PI3K inhibition will be correlated with HPV status, PIK3CA expression, amplification, and mutation, and p110α expression.
PROJECTED ACCRUAL: A total of 20 HPV(+) and 20 HPV(-) tumor tissue specimens from patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
7. Study Design
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polyacrylamide gel electrophoresis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
immunoenzyme technique
Intervention Type
Other
Intervention Name(s)
immunologic technique
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
PIK3CA expression and mutation and p110α amplification and expression in tumor tissue samples from patients with human papilloma virus positive (HPV+) and human papilloma virus negative (HPV-) squamous cell carcinoma (SCC) of the oropharynx
Title
Proliferation and survival after PI3K inhibition in HPV(+) and HPV(-) oropharyngeal SCC cell lines and in HPV E6 and E7 expressing cells
Title
Proliferation and survival after PI3K inhibition in short-term cultures of tumor tissues from patients with HPV(+) and HPV(-) primary SCC of the oropharynx
10. Eligibility
Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Undergoing operative procedures for biopsy and/or resection of squamous cell carcinoma (SCC) of the oropharynx
Tumor tissue sample available from the Head and Neck Tissue Repository and Clinical Database of Vanderbilt University
No tumors with human papilloma virus (HPV) DNA sequences but no expression of E6
PATIENT CHARACTERISTICS:
See Disease Characteristics
PRIOR CONCURRENT THERAPY:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendell G. Yarbrough, MD, FACS
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
12. IPD Sharing Statement
Learn more about this trial
DNA Analysis of Tumor Tissue Samples From Patients With Human Papilloma Virus-Associated Cancer of the Oropharynx
We'll reach out to this number within 24 hrs