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| ID | Type | Description | Link |
|---|---|---|---|
| ECOG-E1608T1 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNA analysis | Genetic | |||
| in situ hybridization | Genetic | |||
| polymerase chain reaction | Genetic | |||
| enzyme-linked immunosorbent assay | Other | |||
| flow cytometry | Other | |||
| immunohistochemistry staining method | Other | |||
| laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response) | 1 year |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Samples from patients who participated in E1608 and provided samples for research.
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| Name | Affiliation | Role |
|---|---|---|
| F. Stephen Hodi, MD | Dana-Farber Cancer Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017403 | In Situ Hybridization |
| D016133 | Polymerase Chain Reaction |
| D004797 | Enzyme-Linked Immunosorbent Assay |
| D005434 | Flow Cytometry |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D009693 | Nucleic Acid Hybridization |
| D005821 | Genetic Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
| D007124 | Immunoenzyme Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007163 | Immunosorbent Techniques |
| D015336 | Molecular Probe Techniques |
| D002469 | Cell Separation |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D006651 | Histocytochemistry |
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