Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease
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|ClinicalTrials.gov Identifier: NCT00897312|
Recruitment Status : Terminated (slow accrual)
First Posted : May 12, 2009
Last Update Posted : April 25, 2016
RATIONALE: Studying samples of blood from patients with cancer, hepatitis C, or Crohn disease in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer and other diseases.
PURPOSE: This laboratory study is looking at the effect of biological therapy on biomarkers in patients with untreated hepatitis C, metastatic melanoma, or Crohn disease.
|Condition or disease||Intervention/treatment|
|Melanoma||Biological: infliximab Biological: pegylated interferon alfa Biological: ticilimumab Drug: ribavirin Other: high performance liquid chromatography Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics|
|Study Start Date :||October 2006|
|Primary Completion Date :||August 2008|
|Study Completion Date :||August 2008|
U.S. FDA Resources
- 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) [ Time Frame: at baseline and 3 to 4 weeks after treatment is initiated ]
- Serum TRP levels at baseline and at 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients) [ Time Frame: at baseline and at 3 to 4 weeks after treatment is initiated ]
- Serum KYN levels at baseline and at 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients) [ Time Frame: at baseline and at 3 to 4 weeks after treatment is initiated ]
Biospecimen Retention: Samples Without DNA
- Serum/plasma samples will be collected from patients being treated for untreated acute and chronic Hepatitis C with pegylated IFN-α and ribavirin
- Serum/plasma samples will be collected from patients being treated for metastatic melanoma with CYP-206,675
- Serum/plasma samples previously collected
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897312
|Study Chair:||Jeffrey A. Sosman, MD||Vanderbilt-Ingram Cancer Center|