Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
NCT ID: NCT01388569
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
48 participants
OBSERVATIONAL
2011-06-28
2011-09-28
Brief Summary
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PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.
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Detailed Description
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Primary
* To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies with clinical outcome.
Secondary
* To correlate circulating anti-sargramostim (GM-CSF) antibody levels with clinical outcome.
OUTLINE: Archived peripheral blood mononuclear cells and serum samples are analyzed for circulating myeloid-derived suppressor cells, Treg (CD3+/CD4+/CD25hi/FOXP3+) frequency, and anti-sargramostim (anti-GM-CSF) antibody levels by flow cytometry and anti-GM-CSF neutralizing antibody assay.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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flow cytometry
immunologic technique
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with melanoma
* Stage IV disease
* HLA-A2\^+ and A2\^+
* Received sargramostim on clinical trial ECOG-4697
* Specimens collected at baseline and either day 43 or day 85 (based on most consistent availability) from long-term survivors and patients with poor survival
PATIENT CHARACTERISTICS:
* Not specified
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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Lisa Butterfield, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Other Identifiers
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ECOG-E4697T1
Identifier Type: -
Identifier Source: secondary_id
CDR0000703098
Identifier Type: -
Identifier Source: org_study_id
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