Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-03-14 @ 5:53 AM
Study NCT ID:
NCT01388569
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2011-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Study Overview
Official Title:
Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.
Detailed Description:
OBJECTIVES:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ECOG-E4697T1 | None | None | View |