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
  Purpose

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 Intervention
Melanoma (Skin)
Other: flow cytometry
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Correlation between anti-GM-CSF antibody levels and clinical outcome [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388569

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Lisa Butterfield, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01388569     History of Changes
Other Study ID Numbers: CDR0000703098, ECOG-E4697T1
Study First Received: July 2, 2011
Last Updated: July 7, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 18, 2014