Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT01358097

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the role of the immune system in the response of squamous cell cancers of the head and neck to treatment that includes radiation therapy. Current research demonstrates that several natural immune cells and molecules affect the way the body's immune system interacts with a cancerous growth. Some cancers may be related to infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of the immune system in head and neck cancers, especially cancers related to HPV infections, can provide valuable information to better understand the body's interaction with cancer cells.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Oropharyngeal Cancer Human Papillomavirus Squamous Cell Cancer

Detailed Description

This is a study of the immune response in patients with oropharyngeal cancer who undergo treatment with radiation, chemoradiation, or robotic surgery. Many oropharyngeal cancers are caused by infection with the human Papillomavirus (HPV), and patients with HPV-mediated tumors have much better prognosis and treatment response compared to patients with HPV-negative tumors. The investigators will test the hypothesis that radiation-based therapy of oropharyngeal cancer is associated with activation of the endogenous HPV-specific immune response. In this study the investigators will collect blood at several time points before, during, and after treatment to monitor the immune response in patients with tumors positive and negative for HPV versus normal healthy volunteers.

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) in Response to Therapy

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Patients with HPV positive tumors
Patients with HPV negative tumors
Control

Outcome Measures

Primary Outcome Measures

HPV-specific T-cell response [at time of enrollment into study (baseline)]
HPV-specific T-cell response [after 3 weeks of treatment]
HPV-specific T-cell response for HPV+ tumors [3 months after completion of treatment]
HPV-specific T-cell response for HPV+ tumors [6 months after completion of treatment]
HPV-specific T-cell response [1 year after completion of treatment]
HPV-specific T-cell response [2 years after completion of treatment]
HPV-specific T-cell response [3 years after completion of treatment]

Secondary Outcome Measures

Circulating immune cells and cytokines [at time of enrollment into study (baseline)]
Circulating immune cells and cytokines [after 3 weeks of treatment]
Circulating immune cells and cytokines [3 months after completion of treatment]
Circulating immune cells and cytokines [6 months after completion of treatment]
Circulating immune cells and cytokines [one year after completion of treatment]
Clinical outcome correlation [three years after treatment]
inflammatory/regulatory cytokines [at time of enrollment (baseline)]
inflammatory/regulatory cytokines [after 3 weeks of treatment]
inflammatory/regulatory cytokines [3 months after completion of treatment]
inflammatory/regulatory cytokines [6 months after completion of treatment]
inflammatory/regulatory cytokines [1 year after completion of treatment]
serum nitrite/nitrate [after 3 weeks of treatment]
serum nitrite/nitrate [3 months after completion of treatment]
serum nitrite/nitrate [6 months after completion of treatment]
serum nitrite/nitrate [1 year after completion of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The patient has biopsy-proven squamous cell carcinoma, Stage II-IV, of the oropharynx or larynx.
The patient is to undergo treatment with radiation, chemo-radiation, or robotic surgery.
The patient is able to give informed consent.
The patient is at least 18 years old.
The patient's ECOG performance status is </=2.

Exclusion Criteria:

The patient has had prior head and neck squamous cell carcinoma, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
The patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
If a cancer survivor, the disease free interval is less than 5 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
The patient is a minor.
The patient is pregnant.
The patient is a prisoner.
The patient is incapable of understanding the consent process.
The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC.
The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.