Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy
Recruitment status was: Not yet recruiting
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.
Biological: recombinant interferon alfa
Genetic: proteomic profiling
Other: immunoenzyme technique
Other: laboratory biomarker analysis
|Official Title:||PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)|
- Serum sample screening via high throughput protein profiling in patients undergoing therapy [ Designated as safety issue: No ]
- Comparison of soluble factors [ Designated as safety issue: No ]
- Comparison of pre-therapy and post-therapy serum samples [ Designated as safety issue: No ]
- Kinetics of soluble factors' appearance, persistence, and disappearance during 12 months of therapy [ Designated as safety issue: No ]
- Predictive significance of specific soluble factors in pre-therapy samples [ Designated as safety issue: No ]
- Correlation of statistically significant factors with S100 and autoimmunity [ Designated as safety issue: No ]
- Confirmation of data obtained by Luminex technology [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897520
|Study Chair:||Monica Panelli, PhD||University of Pittsburgh|