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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897520
• Other study ID #: CDR0000585297
• Secondary ID: ECOG-E1694T1
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 17, 2017
• Start date: January 14, 2008
• Est. completion date: January 24, 2010

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 24, 2010
• Est. primary completion date: January 24, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• recombinant interferon alfa

Genetic:
• proteomic profiling

Other:
• immunoenzyme technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum sample screening via high throughput protein profiling in patients undergoing therapy		1 month
Primary	Comparison of soluble factors		1 month