Trial Information

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

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.