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

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01388569
Collaborator
National Cancer Institute (NCI) (NIH)
48
Enrollment
3
Actual Duration (Months)

Study Details

Study Description

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 Phase
  • Other: flow cytometry
  • Other: immunologic technique
  • Other: laboratory biomarker analysis

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 Design

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 :
Jun 28, 2011
Actual Primary Completion Date :
Sep 28, 2011
Actual Study Completion Date :
Sep 28, 2011

Outcome Measures

Primary Outcome Measures

  1. Overall and disease-free survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lisa Butterfield, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01388569
Other Study ID Numbers:
  • CDR0000703098
  • ECOG-E4697T1
First Posted:
Jul 6, 2011
Last Update Posted:
May 17, 2017
Last Verified:
May 1, 2017
Keywords provided by Eastern Cooperative Oncology Group
stage IV melanoma
Additional relevant MeSH terms:
Melanoma

Study Results

No Results Posted as of May 17, 2017