Trial Information

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

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.