Clinical trial NCT00897546: Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma
Official title: Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage IV melanoma
stage IA melanoma
stage IB melanoma
stage IIA melanoma
stage IIB melanoma
stage IIC melanoma
stage IIIA melanoma
stage IIIB melanoma
stage IIIC melanoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 1716
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E1690 and E1694

Brief 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.

Detailed 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of melanoma OR healthy volunteer (control)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Generation of a comprehensive multiplexed array of melanoma-associated serological markers
timeFrame: 1 month
Secondary outcomes:
measure: Changes in the profile of serological markers induced by interferon-alfa 2b therapy
timeFrame: 1 month
measure: Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Elieser Gorelik, MD, PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1158/1078-0432.CCR-06-1805.