Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Acute or chronic hepatitis C
- •Receiving pegylated interferon alfa and ribavirin
- •Metastatic melanoma
- •Receiving ticilimumab
- •Crohn disease
- •Received prior infliximab
排除标准
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
结局指标
主要结局
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)
时间窗: 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)
时间窗: 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)
时间窗: at baseline and at 3 to 4 weeks after treatment is initiated
次要结局
未报告次要终点
研究者
Jeffrey A. Sosman, MD
Professor of Medicine, Medical Oncologist
Vanderbilt-Ingram Cancer Center