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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Genetic: proteomic profiling
* Other: immunoenzyme technique
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant interferon alfa|nan|
|Genetic: proteomic profiling|nan|
|Other: immunoenzyme technique|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum sample screening via high throughput protein profiling in patients undergoing therapy |  | 1 month | 
| Comparison of soluble factors |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II melanoma, stage III melanoma, stage IV melanoma