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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01388569
First received: July 2, 2011
Last updated: July 7, 2011
Last verified: July 2011

July 2, 2011
July 7, 2011
August 2011
September 2011   (final data collection date for primary outcome measure)
  • Overall and disease-free survival [ Designated as safety issue: No ]
  • Response to GM-CSF impacted by circulating levels of MDSC and Treg [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01388569 on ClinicalTrials.gov Archive Site
Correlation between anti-GM-CSF antibody levels and clinical outcome [ Designated as safety issue: No ]
Same as current
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Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF

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.

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.

Observational
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Melanoma (Skin)
  • Other: flow cytometry
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
48
Not Provided
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
 
NCT01388569
CDR0000703098, ECOG-E4697T1
Not Provided
Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Lisa Butterfield, PhD University of Pittsburgh
National Cancer Institute (NCI)
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP