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Completed

NCT Number: NCT01358097

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HPV-specific T-cell response

    Time frame: at time of enrollment into study (baseline)

  2. HPV-specific T-cell response

    Time frame: after 3 weeks of treatment

  3. HPV-specific T-cell response for HPV+ tumors

    Time frame: 3 months after completion of treatment

  4. HPV-specific T-cell response for HPV+ tumors

    Time frame: 6 months after completion of treatment

  5. HPV-specific T-cell response

    Time frame: 1 year after completion of treatment

  6. HPV-specific T-cell response

    Time frame: 2 years after completion of treatment

  7. HPV-specific T-cell response

    Time frame: 3 years after completion of treatment

Secondary outcomes

  1. Circulating immune cells and cytokines

    Time frame: at time of enrollment into study (baseline)

  2. Circulating immune cells and cytokines

    Time frame: after 3 weeks of treatment

  3. Circulating immune cells and cytokines

    Time frame: 3 months after completion of treatment

  4. Circulating immune cells and cytokines

    Time frame: 6 months after completion of treatment

  5. Circulating immune cells and cytokines

    Time frame: one year after completion of treatment

  6. Clinical outcome correlation

    Time frame: three years after treatment

  7. inflammatory/regulatory cytokines

    Time frame: at time of enrollment (baseline)

  8. inflammatory/regulatory cytokines

    Time frame: after 3 weeks of treatment

  9. inflammatory/regulatory cytokines

    Time frame: 3 months after completion of treatment

  10. inflammatory/regulatory cytokines

    Time frame: 6 months after completion of treatment

  11. inflammatory/regulatory cytokines

    Time frame: 1 year after completion of treatment

  12. serum nitrite/nitrate

    Time frame: after 3 weeks of treatment

  13. serum nitrite/nitrate

    Time frame: 3 months after completion of treatment

  14. serum nitrite/nitrate

    Time frame: 6 months after completion of treatment

  15. serum nitrite/nitrate

    Time frame: 1 year after completion of treatment

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 23, 2011
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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