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Molecular Signatures of HNSCC in Response to Targeted Therapies


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Not Enrolling
Both
Head and Neck Cancer

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Trial Information

Molecular Signatures of HNSCC in Response to Targeted Therapies


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma

- Enrolled on the Head and Neck Tissue Repository and Clinical Database protocol
VU-VICC-HN-0356

- Previously treated with cetuximab monotherapy or cetuximab-based combination
therapy

- Sufficient biological material available for analysis

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

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

Outcome Time Frame:

approximately three years from enrollment of first patient

Safety Issue:

No

Principal Investigator

Barbara Murphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC HN 0715

NCT ID:

NCT00898742

Start Date:

April 2007

Completion Date:

June 2010

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent verrucous carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • salivary gland squamous cell carcinoma
  • stage IV salivary gland cancer
  • Head and Neck Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064