Head and Neck Cancer Clinical Trial
Official title:
Evaluation of Immunologic Responses in HPV-Associated Oropharyngeal Carcinoma Patients Receiving Chemoradiation Therapy
Verified date | November 2018 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 15, 2017 |
Est. primary completion date | February 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Johns Hopkins SKCCC | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare Systemic and Local Immunologic Changes During Chemoradiation | Primary objective: To evaluate the systemic and local immunologic changes which may occur during a standard treatment course of combined chemoradiation for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) and non-HPV associated head and neck squamous cell carcinomas (HNSCC). | Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion | |
Secondary | Relationship of Radiotherapy-Related Lymphopenia and Changes in Cellular Immunity During Chemoradiation | Secondary objective: To explore the relationship between radiotherapy-related lymphopenia and changes in cellular immunity during a course of chemoradiation for HPV-associated OPSCC. | Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion |
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