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

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Genetic: DNA Microarray analysis; Genetic: MALDI-TOF mass spectrometry; Genetic: DNA microarray and MALDI-TOF mass spectrometry

• Registration Number: NCT00898430
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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 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.

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-29
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and neck squamous cell carcinoma patients (HNSCC)	DNA Microarray analysis	-
Head and neck squamous cell carcinoma patients (HNSCC)	MALDI-TOF mass spectrometry	-
Head and neck squamous cell carcinoma patients (HNSCC)	DNA microarray and MALDI-TOF mass spectrometry	-

Primary Outcome Measures

Name	Time	Method
Survival	at expiration of last patient enrolled

Secondary Outcome Measures

Name	Time	Method
Treatment response	upon patient tissue collection

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States