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NCT Number: NCT01958515

Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation

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.

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Key information

Conditions

Head and Neck Cancer Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HPV (Human Papillomavirus)-Associated Carcinoma Head and Neck Neoplasms Infections Neoplasms Neoplasms by Site Oropharyngeal Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Johns Hopkins SKCCC

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

research blood draw and tissue biopsy

Other

research blood draw and tissue biopsy

Primary outcomes

  1. Compare Systemic and Local Immunologic Changes During Chemoradiation

    Time frame: 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

    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).

Secondary outcomes

  1. Relationship of Radiotherapy-Related Lymphopenia and Changes in Cellular Immunity During Chemoradiation

    Time frame: 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 objective: To explore the relationship between radiotherapy-related lymphopenia and changes in cellular immunity during a course of chemoradiation for HPV-associated OPSCC.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of Immunologic Responses in HPV-Associated Oropharyngeal Carcinoma Patients Receiving Chemoradiation Therapy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2013
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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