Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation
Completed
Conditions studied: Head and Neck Cancer, HPV (Human Papillomavirus)-Associated Carcinoma, Oropharyngeal
In brief
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.
Key facts
- Study ID
- NCT01958515
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 20
- Starts
- 2015-01-07
- Expected to finish
- 2017-03-15
- Last updated by the study team
- 2018-11-06
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Johns Hopkins SKCCC — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.