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

Completed

Conditions studied: Head and Neck Cancer, Oropharyngeal Cancer, Human Papillomavirus, Squamous Cell Cancer

In brief

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.

Key facts

Study ID

NCT01358097

Run by

Icahn School of Medicine at Mount Sinai

People needed

33

Starts

2010-10-01

Expected to finish

2013-09-01

Last updated by the study team

2014-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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