Trial record 10 of 109 for:    NIDCD

The Effects of Upper Airway and Digestive Tract Tumors on the Immune System

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001603
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: December 2004
  Purpose

The goal of this study is to learn how tumors of the upper airway and digestive passages (tongue, throat, mouth, and voicebox) affect the body's immune defenses and energy storage.

Previous studies have shown that tumors of the vocal tract produce signals that could help the tumor escape the body's immune defenses and use the body's energy and mineral stores to grow.

Researchers are hoping to learn more about what signals give tumor cells an advantage to live and grow, how tumor cells control these signals, and how these signals affect the rest of the body. This study will look closer at researchers belief that tumors in the vocal tract contain genes (genetic information) that abnormally function to allow the tumors to survive and grow against the attack of the body's normal immune system

Patients with cancerous tumors (squamous cell carcinoma) and benign (non-cancerous) tumors (papilloma) of the upper aerodigestive tract who are candidates for standard or investigational therapy are eligible to participate in this study.

Tumor cells will be collected from patients participating in the study, who will undergo standard surgical treatment or biopsies for their conditions. Once tumor cells are collected they can be analyzed for their genetic make-up.

In addition, patients will undergo several tests using skin, blood, and urine to look closely at the function of their immune systems and metabolism.


Condition
Esophageal Neoplasm
Head and Neck Neoplasm
Laryngeal Neoplasm
Papilloma
Squamous Cell Carcinoma

Study Type: Observational
Official Title: A Pilot Study of Immunoregulatory Factor Expression and Immune Responses in Patients With Squamous Cell Carcinoma or Papilloma of the Upper Aerodigestive Tract

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 93
Study Start Date: December 1996
Estimated Study Completion Date: December 2004
Detailed Description:

Patients with squamous cell carcinoma or papilloma of the upper aerodigestive tract who are candidates for standard or investigational therapy are eligible to participate in this pilot immunopathogenesis study. Patients with these neoplasms exhibit alterations in immune and metabolic regulation. These alterations in immunoregulation have been shown to affect prognosis, and have thus far been an obstacle to the successful development of active immunization and cytokine immunotherapy that have been attempted in order to improve preservation of organ function and survival. This is a pilot study to explore the basis for alterations in immune and metabolic regulation in patients with these tumors. Similar alterations in immunity and metabolism usually occur in response to injury and infection, and are mediated by expression of immunoregulatory signals. The study will evaluate the hypothesis that regulatory and structural genes involved in immunoregulation are abnormally expressed within the tumor and that these signals can promote tumor development and progression by conferring a selective growth or survival advantage. The expression and activity of immunoregulatory genes and signals which are expressed by neoplastic or non-neoplastic cells within the tumor will be analyzed using tumor cells and leukocytes derived from patient specimens obtained during clinically indicated biopsies or surgical therapy. Tumor and keratinocyte cell lines will be established for analysis of differential gene and cytokine expression of neoplastic cells, and lymphocyte cell lines will be established to test culture and signal conditions for stimulating regulatory and effector immune responses of patient lymphocytes in vitro. The potential of factors identified to promote altered immune and metabolic function will be evaluated in the patients by skin, blood and urine immune and metabolic assays performed before and after tumor resection or cytoreduction. Patients participating in these investigations would be expected to benefit from receipt of standard therapy and would encumber minimal additional risk beyond those procedures for the standard or investigational therapy for which the patient will be asked to consent. Twenty patients each with squamous cell carcinoma and papilloma will be accepted to undergo standard therapy under this protocol, and twenty patients may be accepted for study while undergoing therapy on other approved investigational protocol(s). Twenty age-matched clinical research volunteers will be evaluated as control subjects for the skin, blood and urine tests.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

Biopsy proven squamous cell carcinoma or papilloma.

Age greater than 18.

No immunodeficiency (congenital or acquired).

  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: NCT00001603

Locations
United States, Maryland
National Institute on Deafness and Other Communication Disorders (NIDCD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001603     History of Changes
Other Study ID Numbers: 970044, 97-DC-0044
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cytokines
Squamous Cell Carcinoma
Papilloma
Communication
Immunity
Head
Neck
Head and Neck Cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Head and Neck Neoplasms
Laryngeal Neoplasms
Papilloma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014