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Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy

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ClinicalTrials.gov Identifier: NCT00897520
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.


Condition or disease Intervention/treatment
Melanoma (Skin) Biological: recombinant interferon alfa Genetic: proteomic profiling Other: immunoenzyme technique Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

  • To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .
  • To compare soluble factors across all patients at each time point (baseline and during therapy).
  • To compare pre-therapy vs post-therapy serum samples from these patients.
  • To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.
  • To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.
  • To correlate statistically significant factors with S100 and autoimmunity in these patients.
  • To confirm the data obtained with the Luminex technology.

OUTLINE: Patients are stratified according to survival (< 2 years vs > 5 years).

Blood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy.


Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)
Actual Study Start Date : January 14, 2008
Primary Completion Date : January 24, 2010
Study Completion Date : January 24, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Interferon
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Serum sample screening via high throughput protein profiling in patients undergoing therapy [ Time Frame: 1 month ]
  2. Comparison of soluble factors [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients participating in E1694
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of high-risk melanoma
  • Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Contacts and Locations

Information from the National Library of Medicine

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): NCT00897520


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: Monica Panelli, PhD University of Pittsburgh
More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00897520     History of Changes
Other Study ID Numbers: CDR0000585297
ECOG-E1694T1
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
stage II melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs