Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation
Condition: Head and Neck Cancer; HPV (Human Papillomavirus)-Associated Carcinoma; Oropharyngeal
MeSH terms: Carcinoma
Study type: Observational

Summary: 
      The primary purpose of this research is to investigate anti-tumor immune responses in
      patients undergoing chemotherapy and radiation for Head and Neck Cancers.

      Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in
      changes in the tumor microenvironment. We hypothesize that these changes during daily
      fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune
      responses.

      Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy
      in the presence or absence of lymphopenia.

        -  This study will determine whether specific anti-tumor immune responses (Specific
           Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation
           treatment for Head and Neck Cancers.

        -  This study will evaluate the presence or absence of HPV (human papillomavirus) specific
           immune responses before, during, and after treatment for Head and Neck Cancers.

        -  This study will also evaluate whether decreased white blood cell counts may affect
           development of immune responses in Head and Neck cancer patients undergoing treatment.

      Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you
      are older than 18 years of age, capable of providing informed consent, have a life expectancy
      of greater than 4 months, and have a good performance status.

      You are eligible irregardless of your HPV positive or negative status. People with HPV
      positive (human papillomavirus associated) head and neck cancer may join. People with HPV
      negative head and neck cancer may also join.
    

Detailed description: 
      As this is a pilot study seeking to describe the potential impact of chemoradiotherapy on the
      natural history of any immunologic response in HPV-associated OPSCC, the timing of the
      venipunctures reflect the goal to sample throughout the course of CTRT (chemoradiation
      therapy)and will permit some variability based on the number of radiation fractions
      delivered. It also reflects considerations of time points that lend themselves to both the
      venipuncture and tumour biopsy based on the toxicity and response profile of the
      chemoradiation in the HPV-associated OPSCC patient. As such, 10 subjects with HPV-associated
      OPSCC and 10 subjects with non-HPV associated HNSCC seen by the respective disciplines of
      otolaryngology-head and neck surgery, radiation oncology, or medical oncology as clinically
      indicated will be enrolled on this clinical protocol. Importantly, clinical therapeutic
      recommendations, radiation treatment plans, and therapeutic drugs will not be altered by
      enrollment in this protocol. Tumors which are directly visible through in office
      laryngopharyngoscopy and easily accessible (i.e. oropharyngeal tonsil) will be directly
      biopsied (non-percutaneously) and analyzed as detailed below.
    

Intervention name(s): research blood draw and tissue biopsy
Intervention type(s): Other
Intervention description(s): research blood draw and tissue biopsy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 subjects with HPV-associated OPSCC (Oropharyngeal Squamous Cell Carcinoma) and 10
        subjects with non-HPV associated HNSCC (Head and Neck Squamous Cell Carcinoma)
      
Keywords: Radiation Therapy; Chemotherapy; Chemoradiation Therapy