Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897546
• Other study ID #: CDR0000489213
• Secondary ID: ECOG-E1L06T1
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 17, 2017
• Start date: June 1, 2007
• Est. completion date: July 1, 2008

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: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.

Description:

OBJECTIVES:

• Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.

• Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.

• Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.

OUTLINE: This is a multicenter study.

Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.

PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1716
• Est. completion date: July 1, 2008
• Est. primary completion date: July 1, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma OR healthy volunteer (control)

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (1)

Yurkovetsky ZR, Kirkwood JM, Edington HD, Marrangoni AM, Velikokhatnaya L, Winans MT, Gorelik E, Lokshin AE. Multiplex analysis of serum cytokines in melanoma patients treated with interferon-alpha2b. Clin Cancer Res. 2007 Apr 15;13(8):2422-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation of a comprehensive multiplexed array of melanoma-associated serological markers	Generation of a comprehensive multiplexed array of melanoma-associated serological markers	1 month
Secondary	Changes in the profile of serological markers induced by interferon-alfa 2b therapy	Changes in the profile of serological markers induced by interferon-alfa 2b therapy	1 month
Secondary	Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response	Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response	1 month