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Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF


N/A
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Overall and disease-free survival

Safety Issue:

No

Principal Investigator

Lisa Butterfield, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

Unspecified

Study ID:

CDR0000703098

NCT ID:

NCT01388569

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma

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