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

April 8, 2014 updated by: Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with new head and neck cancer, who reside in the tri-state area.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Patients with HPV positive tumors
Patients with HPV negative tumors

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 10-1219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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