Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim
Recruitment status was: Not yet recruiting
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.
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
|Official Title:||Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608|
- Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)
- Mechanisms involved in effective anti-tumor immune response
- Biomarkers predictive of immune reaction with regard to treatment response
- 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
- Effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function
- Anti-cancer immunological activity and effects of the addition of systemic GM-CSF to ipilimumab therapy
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489423
|Principal Investigator:||F. Stephen Hodi, MD||Dana-Farber Cancer Institute|