Trials / Completed
CompletedNCT01489423
Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim
Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 270 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-04-26
- Primary completion
- 2013-05-26
- Completion
- 2013-05-26
- First posted
- 2011-12-09
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT01489423. Inclusion in this directory is not an endorsement.