NCT00617799

Biomarkers That Predict Response to High-Dose Aldesleukin in Metastatic Kidney Cancer or Metastatic Melanoma

Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at biomarkers that predict response to high-dose aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.

Detailed description

OBJECTIVES: * Determine the relationship of peripheral blood lymphocyte phenotype pattern in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose aldesleukin (IL-2). * Determine the relationship of peripheral blood mononuclear cells gene microarray patterns in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose IL-2. * Determine the frequency of mutations on genes encoding for IL-2 receptor A and B. OUTLINE: Patients receive high-dose aldesleukin (IL-2) as part of standard treatment on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline, prior to beginning course 2, and 4 weeks after the completion of course 2. Samples are analyzed using peripheral blood cytometry, gene microarray analysis, and IL-2 receptor single-nucleotide polymorphism techniques.

Conditions

• Kidney Cancer
• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
GENETIC	gene expression analysis
GENETIC	mutation analysis
OTHER	flow cytometry

Timeline

• Start date: 2007-10-02
• Primary completion: 2009-02-18
• Completion: 2010-04-16
• First posted: 2008-02-18
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States