Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
Recruitment status was: Not yet recruiting
RATIONALE: Studying samples of blood from patients treated with sargramostim in the laboratory may help doctors learn more about the effects of sargramostim on cells. It may also help doctors understand how patients respond to treatment.
PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.
Other: flow cytometry
Other: immunologic technique
Other: laboratory biomarker analysis
|Official Title:||Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF|
- Overall and disease-free survival [ Designated as safety issue: No ]
- Response to GM-CSF impacted by circulating levels of MDSC and Treg [ Designated as safety issue: No ]
- Correlation between anti-GM-CSF antibody levels and clinical outcome [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies with clinical outcome.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388569
|Principal Investigator:||Lisa Butterfield, PhD||University of Pittsburgh|