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

NCT01489423 | Completed

• 2 other identifiers: CDR0000718014ECOG-E1608T1
• Study Type: observational
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Melanoma (Skin)

Keywords

stage IIIC melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)

  1 year

Interventions

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples from patients who participated in E1608 and provided samples for research.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Melanoma

Interventions

In Situ Hybridization; Polymerase Chain Reaction; Enzyme-Linked Immunosorbent Assay; Flow Cytometry; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Nucleic Acid Hybridization; Genetic Techniques; Nucleic Acid Amplification Techniques; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Molecular Probe Techniques; Cell Separation; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Histocytochemistry

Study Officials

• F. Stephen Hodi, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 9, 2011
• Study Start: April 26, 2013
• Primary Completion: May 26, 2013
• Study Completion: May 26, 2013
• Last Updated: May 17, 2017

Record last verified: 2017-05