Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT01388569
• Lead Sponsor: Eastern Cooperative Oncology Group

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.

Study Timeline

• Study Start: 2011-06-28
• Study First Submitted: 2011-07-02
• Study First Submitted QC: 2011-07-02
• Study First Posted: 2011-07-06
• Primary Completion: 2011-09-28
• Study Completion: 2011-09-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall and disease-free survival	1 year