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The Effects of Upper Airway and Digestive Tract Tumors on the Immune System Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on The Effects of Upper Airway and Digestive Tract Tumors on the Immune System conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Effects of Upper Airway and Digestive Tract Tumors on the Immune System Clinical research trials and The Effects of Upper Airway and Digestive Tract Tumors on the Immune System health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Effects of Upper Airway and Digestive Tract Tumors on the Immune System. The Effects of Upper Airway and Digestive Tract Tumors on the Immune System Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Effects of Upper Airway and Digestive Tract Tumors on the Immune System clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Effects of Upper Airway and Digestive Tract Tumors on the Immune System condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Effects of Upper Airway and Digestive Tract Tumors on the Immune System  The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
For Condition: Esophageal Neoplasm,Head and Neck Neoplasm,Laryngeal Neoplasm,Papilloma,Squamous Cell Carcinoma
Status: No longer recruiting
Sponsor(s): National Institute on Deafness and Other Communication Disorders (NIDCD) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Biopsy proven squamous cell carcinoma or papilloma. Age greater than 18. No immunodeficiency (congenital or acquired).
Total Enrollment: 93
Location and Contact Information:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970044; 97-DC-0044
Study Start Date: December 16, 1996
Record last reviewed: December 16, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001603
Other Head And Neck Neoplasm Studies:
1. Vaccine Therapy and Detection of Immunologic Responses with Human Papillomavirus 16 E6 and E7 Peptides in Patients with Metastatic or Locally Advanced Cervical Cancer and Other Cancers Carrying the HPV
2. A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer
3. Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer
4. The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
Related Studies:
Other Head and Neck Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
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