Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 11/8/2018 |
| Start Date: | January 7, 2015 |
| End Date: | March 15, 2017 |
Evaluation of Immunologic Responses in HPV-Associated Oropharyngeal Carcinoma Patients Receiving Chemoradiation Therapy
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.
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.
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.
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.
Inclusion Criteria:
- patients must have head and neck cancer and be receiving concurrent chemotherapy and
radiation
- patients greater than or equal to 18 years of age
- patients must be capable of providing informed consent
- patients must have a life expectancy of greater than 4 months
- patients must have an adequate performance status
Exclusion Criteria:
- Patients must not have had surgery for their head and neck cancer
- Patients must not have a diagnosis of an immunosuppressant disease
- Patients must not have certain uncontrolled concurrent illnesses
- Patients must not a history of autoimmune disease
- Patients must not be pregnant, become pregnant or breast feeding
- Patients must not have a history of certain prior malignancies
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