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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897520
Enrollment
40
Registered
2009-05-12
Start date
2008-01-14
Completion date
2010-01-24
Last updated
2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage II melanoma, stage III melanoma, stage IV melanoma

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.

Interventions

BIOLOGICALrecombinant interferon alfa
GENETICproteomic profiling
OTHERimmunoenzyme technique
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Serum sample screening via high throughput protein profiling in patients undergoing therapy1 month
Comparison of soluble factors1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026