Clinical trial NCT01358097: Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy
Official title: Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) in Response to Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Oropharyngeal Cancer
Human Papillomavirus
Squamous Cell Cancer
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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2011-05-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with new head and neck cancer, who reside in the tri-state area.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HPV-specific T-cell response
timeFrame: at time of enrollment into study (baseline)
measure: HPV-specific T-cell response
timeFrame: after 3 weeks of treatment
measure: HPV-specific T-cell response for HPV+ tumors
timeFrame: 3 months after completion of treatment
measure: HPV-specific T-cell response for HPV+ tumors
timeFrame: 6 months after completion of treatment
measure: HPV-specific T-cell response
timeFrame: 1 year after completion of treatment
measure: HPV-specific T-cell response
timeFrame: 2 years after completion of treatment
measure: HPV-specific T-cell response
timeFrame: 3 years after completion of treatment
Secondary outcomes:
measure: Circulating immune cells and cytokines
timeFrame: at time of enrollment into study (baseline)
measure: Circulating immune cells and cytokines
timeFrame: after 3 weeks of treatment
measure: Circulating immune cells and cytokines
timeFrame: 3 months after completion of treatment
measure: Circulating immune cells and cytokines
timeFrame: 6 months after completion of treatment
measure: Circulating immune cells and cytokines
timeFrame: one year after completion of treatment
measure: Clinical outcome correlation
timeFrame: three years after treatment
measure: inflammatory/regulatory cytokines
timeFrame: at time of enrollment (baseline)
measure: inflammatory/regulatory cytokines
timeFrame: after 3 weeks of treatment
measure: inflammatory/regulatory cytokines
timeFrame: 3 months after completion of treatment
measure: inflammatory/regulatory cytokines
timeFrame: 6 months after completion of treatment
measure: inflammatory/regulatory cytokines
timeFrame: 1 year after completion of treatment
measure: serum nitrite/nitrate
timeFrame: after 3 weeks of treatment
measure: serum nitrite/nitrate
timeFrame: 3 months after completion of treatment
measure: serum nitrite/nitrate
timeFrame: 6 months after completion of treatment
measure: serum nitrite/nitrate
timeFrame: 1 year after completion of treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrew Sikora, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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