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Head and Neck CancerNCT01358097

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

An observational study of Head and Neck Cancer and Oropharyngeal Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
33 participants
Where
1 siteUnited States
Study dates
Oct 2010to Sep 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery

    New York, New York, 10029

Other trials in United States

About this study

Official title: 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.

Read the 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.

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
Medical subject headings
Head and Neck Neoplasms, Oropharyngeal Neoplasms, Neoplasms, Squamous Cell, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01358097
Study groupRoleWhat they receive
Patients with HPV positive tumorsNot described
Patients with HPV negative tumorsNot described
ControlNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HPV-specific T-cell response

    Measured: at time of enrollment into study (baseline)

  2. HPV-specific T-cell response

    Measured: after 3 weeks of treatment

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

    Measured: 3 months after completion of treatment

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

    Measured: 6 months after completion of treatment

  5. HPV-specific T-cell response

    Measured: 1 year after completion of treatment

  6. HPV-specific T-cell response

    Measured: 2 years after completion of treatment

  7. HPV-specific T-cell response

    Measured: 3 years after completion of treatment

Secondary outcomes (15)

  1. Circulating immune cells and cytokines

    Measured: at time of enrollment into study (baseline)

  2. Circulating immune cells and cytokines

    Measured: after 3 weeks of treatment

  3. Circulating immune cells and cytokines

    Measured: 3 months after completion of treatment

  4. Circulating immune cells and cytokines

    Measured: 6 months after completion of treatment

  5. Circulating immune cells and cytokines

    Measured: one year after completion of treatment

  6. Clinical outcome correlation

    Measured: three years after treatment

  7. inflammatory/regulatory cytokines

    Measured: at time of enrollment (baseline)

  8. inflammatory/regulatory cytokines

    Measured: after 3 weeks of treatment

  9. inflammatory/regulatory cytokines

    Measured: 3 months after completion of treatment

  10. inflammatory/regulatory cytokines

    Measured: 6 months after completion of treatment

  11. inflammatory/regulatory cytokines

    Measured: 1 year after completion of treatment

  12. serum nitrite/nitrate

    Measured: after 3 weeks of treatment

  13. serum nitrite/nitrate

    Measured: 3 months after completion of treatment

  14. serum nitrite/nitrate

    Measured: 6 months after completion of treatment

  15. serum nitrite/nitrate

    Measured: 1 year after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01358097
Sponsor's protocol ID
GCO 10-1219
Status last verified
Apr 2014
First submitted
19 May 2011
Last updated
10 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.

    PubMed 11668491

  • American Cancer Society. Cancer Facts and Figures, 2007. Available at American Cancer Society, http://www.cancer.org.

  • Nasman A, Attner P, Hammarstedt L, Du J, Eriksson M, Giraud G, Ahrlund-Richter S, Marklund L, Romanitan M, Lindquist D, Ramqvist T, Lindholm J, Sparen P, Ye W, Dahlstrand H, Munck-Wikland E, Dalianis T. Incidence of human papillomavirus (HPV) positive tonsillar carcinoma in Stockholm, Sweden: an epidemic of viral-induced carcinoma? Int J Cancer. 2009 Jul 15;125(2):362-6. doi: 10.1002/ijc.24339.

    PubMed 19330833

  • Ringstrom E, Peters E, Hasegawa M, Posner M, Liu M, Kelsey KT. Human papillomavirus type 16 and squamous cell carcinoma of the head and neck. Clin Cancer Res. 2002 Oct;8(10):3187-92.

    PubMed 12374687

  • Fakhry C, Gillison ML. Clinical implications of human papillomavirus in head and neck cancers. J Clin Oncol. 2006 Jun 10;24(17):2606-11. doi: 10.1200/JCO.2006.06.1291.

    PubMed 16763272

  • Fakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, Forastiere A, Gillison ML. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst. 2008 Feb 20;100(4):261-9. doi: 10.1093/jnci/djn011. Epub 2008 Feb 12.

    PubMed 18270337

  • Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.

    PubMed 20530316

  • Stanley MA. Immune responses to human papilloma viruses. Indian J Med Res. 2009 Sep;130(3):266-76.

    PubMed 19901436

  • Lehoux M, D'Abramo CM, Archambault J. Molecular mechanisms of human papillomavirus-induced carcinogenesis. Public Health Genomics. 2009;12(5-6):268-80. doi: 10.1159/000214918. Epub 2009 Aug 11.

    PubMed 19684440

  • de Vos van Steenwijk PJ, Heusinkveld M, Ramwadhdoebe TH, Lowik MJ, van der Hulst JM, Goedemans R, Piersma SJ, Kenter GG, van der Burg SH. An unexpectedly large polyclonal repertoire of HPV-specific T cells is poised for action in patients with cervical cancer. Cancer Res. 2010 Apr 1;70(7):2707-17. doi: 10.1158/0008-5472.CAN-09-4299. Epub 2010 Mar 16.

    PubMed 20233872

  • Albers A, Abe K, Hunt J, Wang J, Lopez-Albaitero A, Schaefer C, Gooding W, Whiteside TL, Ferrone S, DeLeo A, Ferris RL. Antitumor activity of human papillomavirus type 16 E7-specific T cells against virally infected squamous cell carcinoma of the head and neck. Cancer Res. 2005 Dec 1;65(23):11146-55. doi: 10.1158/0008-5472.CAN-05-0772.

    PubMed 16322265

  • Hoffmann TK, Arsov C, Schirlau K, Bas M, Friebe-Hoffmann U, Klussmann JP, Scheckenbach K, Balz V, Bier H, Whiteside TL. T cells specific for HPV16 E7 epitopes in patients with squamous cell carcinoma of the oropharynx. Int J Cancer. 2006 Apr 15;118(8):1984-91. doi: 10.1002/ijc.21565.

    PubMed 16284959

  • Tindle RW. Immune evasion in human papillomavirus-associated cervical cancer. Nat Rev Cancer. 2002 Jan;2(1):59-65. doi: 10.1038/nrc700.

    PubMed 11902586

  • Grulich AE, van Leeuwen MT, Falster MO, Vajdic CM. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: a meta-analysis. Lancet. 2007 Jul 7;370(9581):59-67. doi: 10.1016/S0140-6736(07)61050-2.

    PubMed 17617273

  • Chaturvedi AK, Madeleine MM, Biggar RJ, Engels EA. Risk of human papillomavirus-associated cancers among persons with AIDS. J Natl Cancer Inst. 2009 Aug 19;101(16):1120-30. doi: 10.1093/jnci/djp205. Epub 2009 Jul 31.

    PubMed 19648510

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer and Oropharyngeal Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HPV-specific T-cell response (time frame: at time of enrollment into study (baseline)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01358097, which also lists 51 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014; AzTrials last refreshed its copy on 26 Oct 2026.

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