Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation

NCT01958515 | Completed DMC

• 2 other identifiers: J13158IRB00092006
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; HPV (Human Papillomavirus)-Associated Carcinoma; Oropharyngeal

Keywords

Radiation Therapy; Chemotherapy; Chemoradiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  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

Study Arms (1)

Chemoradiation with Research Samples

Standard of care chemoradiation therapy will be given as clinically indicated by the treating physicians. 4 research blood and tissue samples will be obtained. One before treatment starts, 2 while treatments are being received and finally one after treatments are completed.

Other: research blood draw and tissue biopsy

Interventions

research blood draw and tissue biopsy OTHER

research blood draw and tissue biopsy

Chemoradiation with Research Samples

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Johns Hopkins SKCCC

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry Quon, M.D.

  Johns Hopkins SKCCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: January 7, 2015
• Primary Completion: February 15, 2017
• Study Completion: March 15, 2017
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

US (1)