Clinical trial NCT00897312: Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease
Official title: Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Keywords: stage IV melanoma
hepatitis C infection
melanoma (skin)
precancerous/nonmalignant condition
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Hepatitis C; Anti-TNF in patients with active inflammatory bowel disease(IBD); anti-CTLA Ig in patients with metastatic melanoma

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not specified

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: 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)
timeFrame: at baseline and 3 to 4 weeks after treatment is initiated
measure: Serum TRP levels at baseline and at 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients)
timeFrame: at baseline and at 3 to 4 weeks after treatment is initiated
measure: Serum KYN levels at baseline and at 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients)
timeFrame: at baseline and at 3 to 4 weeks after treatment is initiated
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jeffrey A. Sosman, MD
role: STUDY_CHAIR
References: