Trials / Completed
CompletedNCT01388569
Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 48 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | flow cytometry | |
| OTHER | immunologic technique | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2011-06-28
- Primary completion
- 2011-09-28
- Completion
- 2011-09-28
- First posted
- 2011-07-06
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT01388569. Inclusion in this directory is not an endorsement.