Biomarkers in Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy

This study has been terminated.
(Study closed prematurely upon PI's departure)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00898430
First received: May 9, 2009
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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 patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in predicting response to treatment in patients with newly diagnosed stage III or stage IV head and neck cancer treated with carboplatin, paclitaxel, and radiation therapy.


Condition Intervention
Head and Neck Cancer
Genetic: DNA Microarray analysis
Genetic: MALDI-TOF mass spectrometry
Genetic: DNA microarray and MALDI-TOF mass spectrometry

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomarkers of Survival in HNSCC

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Survival [ Time Frame: at expiration of last patient enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment response [ Time Frame: upon patient tissue collection ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: November 2003
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Head and neck squamous cell carcinoma patients (HNSCC) Genetic: DNA Microarray analysis
Tumors will be assayed on Affymetrix Human Genome U133 GeneChip
Genetic: MALDI-TOF mass spectrometry
Supervised analysis techniques will be employed to identify patterns of protein peaks useful for treatment response and survival prediction. Hierarchical clustering analyses will be used to visualize data.
Genetic: DNA microarray and MALDI-TOF mass spectrometry
Tumors from the specific Aim 1/2 and from preliminary data, previously analyzed, will be examined for HPV 16 infection.

Detailed Description:

OBJECTIVES:

  • Determine if gene expression patterns that correlate with treatment response and survival can be identified using DNA microarrays in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) treated with carboplatin, paclitaxel, and radiotherapy.
  • Determine if protein expression patterns that correlate with treatment response and survival in HNSCC can be identified using matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOFMS).
  • Determine if the molecular signature of human papilloma virus-16 infection can be determined using DNA microarray and MALDI-TOFMS and correlate with gene and protein expression, treatment response, and survival.

OUTLINE: Tumor tissue samples are analyzed by DNA microarray analysis and validated by quantitative reverse transcription-polymerase chain reaction (PCR). Protein and gene expression patterns are analyzed by laser desorption ionization-time-of-flight mass spectrometry, high performance liquid chromatography, liquid chromatography-tandem mass spectrometry, and PCR. Samples are also analyzed by tissue microarray and immunohistochemistry.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Head and Neck cancer patients who are uniformly treated with concurrent carboplatin/paclitaxel and radiation.

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed head and neck squamous cell carcinoma

    • Stage III-IV disease
  • Scheduled for pan-endoscopy
  • Tumor tissue available from patients treated with carboplatin, paclitaxel, and radiotherapy on protocol VU-VICC-HN-0356

PATIENT CHARACTERISTICS:

  • Able to speak English

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898430

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Barbara Murphy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00898430     History of Changes
Other Study ID Numbers: VICC HN 0392, P30CA068485, VU-VICC-HN-0392, VU-VICC-030933
Study First Received: May 9, 2009
Last Updated: March 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
metastatic squamous neck cancer with occult primary squamous cell carcinoma
untreated metastatic squamous neck cancer with occult primary
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
salivary gland squamous cell carcinoma
stage III salivary gland cancer
stage IV salivary gland cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014