Melanoma (Skin) Clinical Trial
Official title:
Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608
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.
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.
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