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.
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
- Conditions the study is for
- Head and Neck Cancer, Oropharyngeal Cancer, Human Papillomavirus
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2013
- Phase
- Observational
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.
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- 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
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 group | Role | What they receive |
|---|---|---|
| Patients with HPV positive tumors | Not described | |
| Patients with HPV negative tumors | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV-specific T-cell response
Measured: at time of enrollment into study (baseline)
HPV-specific T-cell response
Measured: after 3 weeks of treatment
HPV-specific T-cell response for HPV+ tumors
Measured: 3 months after completion of treatment
HPV-specific T-cell response for HPV+ tumors
Measured: 6 months after completion of treatment
HPV-specific T-cell response
Measured: 1 year after completion of treatment
HPV-specific T-cell response
Measured: 2 years after completion of treatment
HPV-specific T-cell response
Measured: 3 years after completion of treatment
Secondary outcomes (15)
Circulating immune cells and cytokines
Measured: at time of enrollment into study (baseline)
Circulating immune cells and cytokines
Measured: after 3 weeks of treatment
Circulating immune cells and cytokines
Measured: 3 months after completion of treatment
Circulating immune cells and cytokines
Measured: 6 months after completion of treatment
Circulating immune cells and cytokines
Measured: one year after completion of treatment
Clinical outcome correlation
Measured: three years after treatment
inflammatory/regulatory cytokines
Measured: at time of enrollment (baseline)
inflammatory/regulatory cytokines
Measured: after 3 weeks of treatment
inflammatory/regulatory cytokines
Measured: 3 months after completion of treatment
inflammatory/regulatory cytokines
Measured: 6 months after completion of treatment
inflammatory/regulatory cytokines
Measured: 1 year after completion of treatment
serum nitrite/nitrate
Measured: after 3 weeks of treatment
serum nitrite/nitrate
Measured: 3 months after completion of treatment
serum nitrite/nitrate
Measured: 6 months after completion of treatment
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.
- First posted23 May 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Sikora, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
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 11668491American 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 19330833Ringstrom 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 12374687Fakhry 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 16763272Fakhry 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 18270337Ang 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 20530316Stanley MA. Immune responses to human papilloma viruses. Indian J Med Res. 2009 Sep;130(3):266-76.
PubMed 19901436Lehoux 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 19684440de 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 20233872Albers 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 16322265Hoffmann 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 16284959Tindle RW. Immune evasion in human papillomavirus-associated cervical cancer. Nat Rev Cancer. 2002 Jan;2(1):59-65. doi: 10.1038/nrc700.
PubMed 11902586Grulich 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 17617273Chaturvedi 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