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

May 17, 2017 updated by: ECOG-ACRIN Cancer Research Group

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

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.

Study Overview

Status

Completed

Conditions

Melanoma (Skin)

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples submitted for research from patients participating in E1694

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Monica Panelli, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2008

Primary Completion (Actual)

January 24, 2010

Study Completion (Actual)

January 24, 2010

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria