Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with ipilimumab with or without sargramostim may help doctors learn more about the effects of ipilimumab and sargramostim on cells. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.

Detailed Description
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OBJECTIVES: To compare the pathology of primary melanomas, melanoma metastases, and post-treatment melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab plus sargramostim (GM-CSF) and patients receiving ipilimumab alone. To determine the effects of the addition of systemic GM-CSF to ipilimumab on effector immune function in patients with metastatic melanoma. To determine the effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function in patients with metastatic melanoma. To determine the effects of the addition of systemic GM-CSF to ipilimumab on anti-tumor humoral immunity in patients with metastatic melanoma. OUTLINE: Serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical outcomes, immune function, and anti-tumor humoral immunity by IHC, RT-PCR, flow cytometry, ELISPOT assays, and ELISA.

Official Title
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Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Genetic: RNA analysis
* Genetic: in situ hybridization
* Genetic: polymerase chain reaction
* Other: enzyme-linked immunosorbent assay
* Other: flow cytometry
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of measurable unresectable stage III or stage IV melanoma Treated with ipilimumab with or without sargramostim on clinical trial ECOG-E1608 Primary tumor tissue and optional post-treatment biopsies of tumors from easily accessible tissues PATIENT CHARACTERISTICS: ECOG performance status 0 or 1 PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: in situ hybridization|nan|
|Genetic: polymerase chain reaction|nan|
|Other: enzyme-linked immunosorbent assay|nan|
|Other: flow cytometry|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIC melanoma, stage IV melanoma, recurrent melanoma