Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim
NCT ID: NCT01489423
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
270 participants
OBSERVATIONAL
2013-04-26
2013-05-26
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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RNA analysis
in situ hybridization
polymerase chain reaction
enzyme-linked immunosorbent assay
flow cytometry
immunohistochemistry staining method
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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F. Stephen Hodi, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Other Identifiers
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ECOG-E1608T1
Identifier Type: -
Identifier Source: secondary_id
CDR0000718014
Identifier Type: -
Identifier Source: org_study_id
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