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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 2, 2011
Last updated: July 7, 2011
Last verified: July 2011

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 Intervention
Melanoma (Skin)
Other: flow cytometry
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall and disease-free survival
  • Response to GM-CSF impacted by circulating levels of MDSC and Treg

Secondary Outcome Measures:
  • Correlation between anti-GM-CSF antibody levels and clinical outcome

Estimated Enrollment: 48
Study Start Date: August 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01388569

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

Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT01388569     History of Changes
Other Study ID Numbers: CDR0000703098
Study First Received: July 2, 2011
Last Updated: July 7, 2011

Keywords provided by National Cancer Institute (NCI):
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 processed this record on April 28, 2017