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

NCT ID: NCT00897520

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-14
• Study Completion Date: 2010-01-24

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.

Conditions

Melanoma (Skin)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

recombinant interferon alfa

Intervention Type: BIOLOGICAL

proteomic profiling

Intervention Type: GENETIC

immunoenzyme technique

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Panelli, PhD

Role: STUDY_CHAIR

University of Pittsburgh

Other Identifiers

ECOG-E1694T1

Identifier Type: -

Identifier Source: secondary_id

CDR0000585297

Identifier Type: -

Identifier Source: org_study_id