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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Head and Neck Cancer

Treatments: Genetic: MALDI-TOF mass spectrometry; Genetic: DNA Microarray analysis; Genetic: DNA microarray and MALDI-TOF mass spectrometry

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00898430

VU-VICC-HN-0392

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-030933

VICC HN 0392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

49 participants in 1 patient group

Head and neck squamous cell carcinoma patients (HNSCC)

Treatment:

Genetic: MALDI-TOF mass spectrometry

Genetic: DNA Microarray analysis

Genetic: DNA microarray and MALDI-TOF mass spectrometry