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

NCT01358097 | Completed

• 1 other identifier: GCO 10-1219
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• HPV-specific T-cell response

  at time of enrollment into study (baseline)

• HPV-specific T-cell response

  after 3 weeks of treatment

• HPV-specific T-cell response for HPV+ tumors

  3 months after completion of treatment

• HPV-specific T-cell response for HPV+ tumors

  6 months after completion of treatment

• HPV-specific T-cell response

  1 year after completion of treatment

• HPV-specific T-cell response

  2 years after completion of treatment

• HPV-specific T-cell response

  3 years after completion of treatment

Secondary Outcomes (15)

• Circulating immune cells and cytokines

  at time of enrollment into study (baseline)

• Circulating immune cells and cytokines

  after 3 weeks of treatment

• Circulating immune cells and cytokines

  3 months after completion of treatment

• Circulating immune cells and cytokines

  6 months after completion of treatment

• Circulating immune cells and cytokines

  one year after completion of treatment

Study Arms (3)

Patients with HPV positive tumors

Patients with HPV negative tumors

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery

New York, New York, 10029, United States

Location

Related Publications (51)

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Biospecimen

Retention: SAMPLES WITH DNA

Serum, peripheral blood mononuclear cells

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma

Study Officials

• Andrew Sikora, MD, PhD

  Icahn School of Medicine at Mount Sinai

  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: May 19, 2011
• First Posted: May 23, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

US (1)