Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)
Safety Issue:
No
Principal Investigator
F. Stephen Hodi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
Unspecified
Study ID:
CDR0000718014
NCT ID:
NCT01489423
Start Date:
September 2012
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage IIIC melanoma
- stage IV melanoma
- recurrent melanoma
- Melanoma
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