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

Melanoma (Skin) Clinical Trial

Official title:

Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489423
• Other study ID #: CDR0000718014
• Secondary ID: ECOG-E1608T1
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: May 16, 2017
• Start date: April 26, 2013
• Est. completion date: May 26, 2013

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 26, 2013
• Est. primary completion date: May 26, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• RNA analysis

• in situ hybridization

• polymerase chain reaction

Other:
• enzyme-linked immunosorbent assay

• flow cytometry

• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)		1 year