Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01489423
First received: December 8, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with ipilimumab with or without sargramostim may help doctors learn more about the effects of ipilimumab and sargramostim on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.


Condition Intervention
Melanoma (Skin)
Genetic: RNA analysis
Genetic: in situ hybridization
Genetic: polymerase chain reaction
Other: enzyme-linked immunosorbent assay
Other: flow cytometry
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response) [ Designated as safety issue: No ]
  • Mechanisms involved in effective anti-tumor immune response [ Designated as safety issue: No ]
  • Biomarkers predictive of immune reaction with regard to treatment response [ Designated as safety issue: No ]
  • Changes in circulating immune effector cells (T-cell, B-cell, NK, and NK T cells), circulating plasmacytoid dendritic cell (DC), myeloid DC, and melanoma-associated antigen-specific T cell associated with treatment response [ Designated as safety issue: No ]
  • Effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function [ Designated as safety issue: No ]
  • Anti-cancer immunological activity and effects of the addition of systemic GM-CSF to ipilimumab therapy [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To compare the pathology of primary melanomas, melanoma metastases, and post-treatment melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab plus sargramostim (GM-CSF) and patients receiving ipilimumab alone.
  • To determine the effects of the addition of systemic GM-CSF to ipilimumab on effector immune function in patients with metastatic melanoma.
  • To determine the effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function in patients with metastatic melanoma.
  • To determine the effects of the addition of systemic GM-CSF to ipilimumab on anti-tumor humoral immunity in patients with metastatic melanoma.

OUTLINE: Serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical outcomes, immune function, and anti-tumor humoral immunity by IHC, RT-PCR, flow cytometry, ELISPOT assays, and ELISA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of measurable unresectable stage III or stage IV melanoma
  • Treated with ipilimumab with or without sargramostim on clinical trial ECOG-E1608
  • Primary tumor tissue and optional post-treatment biopsies of tumors from easily accessible tissues

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489423

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01489423     History of Changes
Other Study ID Numbers: CDR0000718014, ECOG-E1608T1
Study First Received: December 8, 2011
Last Updated: December 8, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIC melanoma
stage IV melanoma
recurrent 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 April 21, 2014