Squamous Cell Carcinoma Clinical Trial
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
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | December 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA Biopsy proven squamous cell carcinoma or papilloma. Age greater than 18. No immunodeficiency (congenital or acquired). |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute on Deafness and Other Communication Disorders (NIDCD) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Gallo O, Gori AM, Attanasio M, Martini F, Giusti B, Brunelli T, Gallina E. Interleukin-6 and acute-phase proteins in head and neck cancer. Eur Arch Otorhinolaryngol. 1995;252(3):159-62. — View Citation
Sato K, Mimura H, Han DC, Kakiuchi T, Ueyama Y, Ohkawa H, Okabe T, Kondo Y, Ohsawa N, Tsushima T, et al. Production of bone-resorbing activity and colony-stimulating activity in vivo and in vitro by a human squamous cell carcinoma associated with hypercalcemia and leukocytosis. J Clin Invest. 1986 Jul;78(1):145-54. — View Citation
Wang MB, Lichtenstein A, Mickel RA. Hierarchical immunosuppression of regional lymph nodes in patients with head and neck squamous cell carcinoma. Otolaryngol Head Neck Surg. 1991 Oct;105(4):517-27. — View Citation
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