Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) in Response to Therapy
18 Years
N/A
Both
Head and Neck Cancer, Oropharyngeal Cancer, Human Papillomavirus, Squamous Cell Cancer
Trial Information
Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) in Response to Therapy
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.
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
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.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
HPV-specific T-cell response
Outcome Time Frame:
at time of enrollment into study (baseline)
Safety Issue:
No
Principal Investigator
Andrew Sikora, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mount Sinai School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
GCO # 10-1219
NCT ID:
NCT01358097
Start Date:
October 2010
Completion Date:
December 2012
Related Keywords:
- Head and Neck Cancer
- Oropharyngeal Cancer
- Human Papillomavirus
- Squamous Cell Cancer
- 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
- Carcinoma
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Oropharyngeal Neoplasms
Name | Location |
|---|---|
| The Mount Sinai Medical Center, Otolaryngology - Head and Neck Surgery | New York, New York 10029 |
