Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics
OBJECTIVES:
- To determine how a variety of immune-modulating therapies (i.e., interferon alfa
[IFN-α] in patients with untreated acute or chronic hepatitis C, anti-tumor necrosis
factor in patients with active inflammatory bowel disease (i.e., Crohn disease), and
anticytotoxic T-lymphocyte antigen immunoglobulin in patients with metastatic melanoma)
affect the tissue expression of indoleamine 2, 3 dioxygenase (IDO), a major
immune-regulatory mechanism.
- To determine whether administration of pegylated INF-α in patients with untreated acute
and chronic hepatitis C causes systemic changes in the IDO pathway, as indicated by
lowered serum tryptophan (TRP) and elevated serum kynurenine (KYN).
- To determine whether administration of ticilimumab (i.e., anti-CTLA4 human monoclonal
antibody CP-675,206) in patients with metastatic melanoma inhibits activation of the
IDO pathway as indicated by normal serum TRP and normal serum KYN.
- To determine whether administration of infliximab in patients with Crohn disease
inhibits activation of the IDO pathway, as indicated by normal serum TRP and normal
serum KYN.
OUTLINE: Serum samples are collected from patients with hepatitis C and metastatic melanoma
at baseline and at 3 to 4 weeks after treatment is initiated. Previously collected samples
from patients with Crohn disease are also assessed at these time points. Samples are
analyzed for tryptophan and kynurenine levels via high-performance liquid chromatography.
PROJECTED ACCRUAL: A total of 15 patients with untreated acute or chronic Hepatitis C, 15
patients with metastatic melanoma, and 20 patients with Crohn disease will be accrued for
this study.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Systemic indoleamine 2, 3 dioxygenase levels in tissue at baseline and 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients)
at baseline and 3 to 4 weeks after treatment is initiated
No
Jeffrey A. Sosman, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC MEL0651
NCT00897312
August 2006
August 2008
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