Clinical trial NCT00897520: Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy
Official title: PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin)
Keywords: stage II melanoma
stage III melanoma
stage IV melanoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 40
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E1694

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.

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.

Eligibility 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

Primary outcomes:
measure: Serum sample screening via high throughput protein profiling in patients undergoing therapy
timeFrame: 1 month
measure: Comparison of soluble factors
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Monica Panelli, PhD
role: STUDY_CHAIR
References: