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

E

Eastern Cooperative Oncology Group

Status

Completed

Conditions

Melanoma (Skin)

Treatments

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

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01388569
CDR0000703098
ECOG-E4697T1

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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