Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897312
First received: May 9, 2009
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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 Intervention
Melanoma
Biological: infliximab
Biological: pegylated interferon alfa
Biological: ticilimumab
Drug: ribavirin
Other: high performance liquid chromatography
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Enrollment: 7
Study Start Date: August 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: infliximab
    Not specified
    Other Name: Remicade
    Biological: pegylated interferon alfa
    not specified
    Other Name: pegylated interferon-a
    Biological: ticilimumab
    not specified
    Other Name: CP-675206
    Drug: ribavirin
    not specified
    Other Name: Copegus, Rebetol, Ribasphere
    Other: high performance liquid chromatography
    not specified
    Other Name: not noted
    Other: laboratory biomarker analysis
    not specified
    Other Name: not noted
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897312

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Jeffrey A. Sosman, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey Sosman, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897312     History of Changes
Other Study ID Numbers: VICC MEL0651, VU-VICC-MEL-0651, VU-VICC-060614
Study First Received: May 9, 2009
Last Updated: April 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
stage IV melanoma
hepatitis C infection
melanoma (skin)
precancerous/nonmalignant condition

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Melanoma
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Infliximab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2014