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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01388569
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : May 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Melanoma (Skin) Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis

Detailed Description:



  • 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
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Overall and disease-free survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patient enrolled on E4697 from whom samples were submitted for research


  • 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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01388569

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Lisa Butterfield, PhD University of Pittsburgh

Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT01388569     History of Changes
Other Study ID Numbers: CDR0000703098
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group:
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas