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Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01358097
First received: May 19, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to investigate the role of the immune system in the response of squamous cell cancers of the head and neck to treatment that includes radiation therapy. Current research demonstrates that several natural immune cells and molecules affect the way the body's immune system interacts with a cancerous growth. Some cancers may be related to infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of the immune system in head and neck cancers, especially cancers related to HPV infections, can provide valuable information to better understand the body's interaction with cancer cells.


Condition
Head and Neck Cancer
Oropharyngeal Cancer
Human Papillomavirus
Squamous Cell Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) in Response to Therapy

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • HPV-specific T-cell response [ Time Frame: at time of enrollment into study (baseline) ] [ Designated as safety issue: No ]
  • HPV-specific T-cell response [ Time Frame: after 3 weeks of treatment ] [ Designated as safety issue: No ]
  • HPV-specific T-cell response for HPV+ tumors [ Time Frame: 3 months after completion of treatment ] [ Designated as safety issue: No ]
  • HPV-specific T-cell response for HPV+ tumors [ Time Frame: 6 months after completion of treatment ] [ Designated as safety issue: No ]
  • HPV-specific T-cell response [ Time Frame: 1 year after completion of treatment ] [ Designated as safety issue: No ]
  • HPV-specific T-cell response [ Time Frame: 2 years after completion of treatment ] [ Designated as safety issue: No ]
  • HPV-specific T-cell response [ Time Frame: 3 years after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Circulating immune cells and cytokines [ Time Frame: at time of enrollment into study (baseline) ] [ Designated as safety issue: No ]
  • Circulating immune cells and cytokines [ Time Frame: after 3 weeks of treatment ] [ Designated as safety issue: No ]
  • Circulating immune cells and cytokines [ Time Frame: 3 months after completion of treatment ] [ Designated as safety issue: No ]
  • Circulating immune cells and cytokines [ Time Frame: 6 months after completion of treatment ] [ Designated as safety issue: No ]
  • Circulating immune cells and cytokines [ Time Frame: one year after completion of treatment ] [ Designated as safety issue: No ]
  • Clinical outcome correlation [ Time Frame: three years after treatment ] [ Designated as safety issue: No ]
  • inflammatory/regulatory cytokines [ Time Frame: at time of enrollment (baseline) ] [ Designated as safety issue: No ]
  • inflammatory/regulatory cytokines [ Time Frame: after 3 weeks of treatment ] [ Designated as safety issue: No ]
  • inflammatory/regulatory cytokines [ Time Frame: 3 months after completion of treatment ] [ Designated as safety issue: No ]
  • inflammatory/regulatory cytokines [ Time Frame: 6 months after completion of treatment ] [ Designated as safety issue: No ]
  • inflammatory/regulatory cytokines [ Time Frame: 1 year after completion of treatment ] [ Designated as safety issue: No ]
  • serum nitrite/nitrate [ Time Frame: after 3 weeks of treatment ] [ Designated as safety issue: No ]
  • serum nitrite/nitrate [ Time Frame: 3 months after completion of treatment ] [ Designated as safety issue: No ]
  • serum nitrite/nitrate [ Time Frame: 6 months after completion of treatment ] [ Designated as safety issue: No ]
  • serum nitrite/nitrate [ Time Frame: 1 year after completion of treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, peripheral blood mononuclear cells


Enrollment: 33
Study Start Date: October 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with HPV positive tumors
Patients with HPV negative tumors
Control

Detailed Description:

This is a study of the immune response in patients with oropharyngeal cancer who undergo treatment with radiation, chemoradiation, or robotic surgery. Many oropharyngeal cancers are caused by infection with the human Papillomavirus (HPV), and patients with HPV-mediated tumors have much better prognosis and treatment response compared to patients with HPV-negative tumors. The investigators will test the hypothesis that radiation-based therapy of oropharyngeal cancer is associated with activation of the endogenous HPV-specific immune response. In this study the investigators will collect blood at several time points before, during, and after treatment to monitor the immune response in patients with tumors positive and negative for HPV versus normal healthy volunteers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with new head and neck cancer, who reside in the tri-state area.

Criteria

Inclusion Criteria:

  • The patient has biopsy-proven squamous cell carcinoma, Stage II-IV, of the oropharynx or larynx.
  • The patient is to undergo treatment with radiation, chemo-radiation, or robotic surgery.
  • The patient is able to give informed consent.
  • The patient is at least 18 years old.
  • The patient's ECOG performance status is </=2.

Exclusion Criteria:

  • The patient has had prior head and neck squamous cell carcinoma, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  • The patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  • If a cancer survivor, the disease free interval is less than 5 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  • The patient is a minor.
  • The patient is pregnant.
  • The patient is a prisoner.
  • The patient is incapable of understanding the consent process.
  • The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC.
  • The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358097

Locations
United States, New York
Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Andrew Sikora, MD, PhD Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01358097     History of Changes
Other Study ID Numbers: GCO 10-1219
Study First Received: May 19, 2011
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Head and neck cancer
Oropharyngeal cancer
Human papillomavirus
Squamous cell carcinoma
Radiation treatment
Chemotherapy
Induction chemotherapy
Immune status
Immune monitoring
head and neck robotic surgery

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 25, 2014