Head and Neck Cancer, Human Papillomavirus, Oropharyngeal Cancer, Squamous Cell Cancer
Conditions
Keywords
Head and neck cancer, Oropharyngeal cancer, Human papillomavirus, Squamous cell carcinoma, Radiation treatment, Chemotherapy, Induction chemotherapy, Immune status, Immune monitoring, head and neck robotic surgery
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.
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.
Interventions
None listed
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV-specific T-cell response | at time of enrollment into study (baseline) |
| HPV-specific T-cell response for HPV+ tumors | 3 months after completion of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Circulating immune cells and cytokines | at time of enrollment into study (baseline) |
| Clinical outcome correlation | three years after treatment |
| inflammatory/regulatory cytokines | at time of enrollment (baseline) |
| serum nitrite/nitrate | after 3 weeks of treatment |
Countries
United States
Outcome results
None listed