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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01358097
Other study ID # GCO 10-1219
Secondary ID
Status Completed
Phase N/A
First received May 19, 2011
Last updated April 8, 2014
Start date October 2010
Est. completion date September 2013

Study information

Verified date April 2014
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (51)

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Haile LA, von Wasielewski R, Gamrekelashvili J, Krüger C, Bachmann O, Westendorf AM, Buer J, Liblau R, Manns MP, Korangy F, Greten TF. Myeloid-derived suppressor cells in inflammatory bowel disease: a new immunoregulatory pathway. Gastroenterology. 2008 Sep;135(3):871-81, 881.e1-5. doi: 10.1053/j.gastro.2008.06.032. Epub 2008 Jun 12. — View Citation

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. — View Citation

Kadish AS, Ho GY, Burk RD, Wang Y, Romney SL, Ledwidge R, Angeletti RH. Lymphoproliferative responses to human papillomavirus (HPV) type 16 proteins E6 and E7: outcome of HPV infection and associated neoplasia. J Natl Cancer Inst. 1997 Sep 3;89(17):1285-93. — View Citation

Kadish AS, Timmins P, Wang Y, Ho GY, Burk RD, Ketz J, He W, Romney SL, Johnson A, Angeletti R, Abadi M; Albert Einstein Cervix Dysplasia Clinical Consortium. Regression of cervical intraepithelial neoplasia and loss of human papillomavirus (HPV) infection is associated with cell-mediated immune responses to an HPV type 16 E7 peptide. Cancer Epidemiol Biomarkers Prev. 2002 May;11(5):483-8. — View Citation

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* Note: There are 51 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary HPV-specific T-cell response at time of enrollment into study (baseline) No
Primary HPV-specific T-cell response after 3 weeks of treatment No
Primary HPV-specific T-cell response for HPV+ tumors 3 months after completion of treatment No
Primary HPV-specific T-cell response for HPV+ tumors 6 months after completion of treatment No
Primary HPV-specific T-cell response 1 year after completion of treatment No
Primary HPV-specific T-cell response 2 years after completion of treatment No
Primary HPV-specific T-cell response 3 years after completion of treatment No
Secondary Circulating immune cells and cytokines at time of enrollment into study (baseline) No
Secondary Circulating immune cells and cytokines after 3 weeks of treatment No
Secondary Circulating immune cells and cytokines 3 months after completion of treatment No
Secondary Circulating immune cells and cytokines 6 months after completion of treatment No
Secondary Circulating immune cells and cytokines one year after completion of treatment No
Secondary Clinical outcome correlation three years after treatment No
Secondary inflammatory/regulatory cytokines at time of enrollment (baseline) No
Secondary inflammatory/regulatory cytokines after 3 weeks of treatment No
Secondary inflammatory/regulatory cytokines 3 months after completion of treatment No
Secondary inflammatory/regulatory cytokines 6 months after completion of treatment No
Secondary inflammatory/regulatory cytokines 1 year after completion of treatment No
Secondary serum nitrite/nitrate after 3 weeks of treatment No
Secondary serum nitrite/nitrate 3 months after completion of treatment No
Secondary serum nitrite/nitrate 6 months after completion of treatment No
Secondary serum nitrite/nitrate 1 year after completion of treatment No
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