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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01388569

Enrollment

Registered

2011-07-06

Start date

2011-06-28

Completion date

2011-09-28

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma

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.

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.

Interventions

OTHERflow cytometry

OTHERimmunologic technique

OTHERlaboratory biomarker analysis

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

Design outcomes

Primary

Measure	Time frame
Overall and disease-free survival	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026