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NCT01388569 Clinical Trial

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

Melanoma (Skin) Clinical Trial

Official title:
Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01388569
Other study ID # CDR0000703098
Secondary ID ECOG-E4697T1
Status Completed
Phase N/A
First received July 2, 2011
Last updated May 16, 2017
Start date June 28, 2011
Est. completion date September 28, 2011

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date September 28, 2011
Est. primary completion date September 28, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• flow cytometry

• immunologic technique

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Overall and disease-free survival 1 year
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