Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
|ClinicalTrials.gov Identifier: NCT01388569|
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF|
|Actual Study Start Date :||June 28, 2011|
|Actual Primary Completion Date :||September 28, 2011|
|Actual Study Completion Date :||September 28, 2011|
- Overall and disease-free survival [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388569
|Principal Investigator:||Lisa Butterfield, PhD||University of Pittsburgh|