Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Cancer
- Sponsor
- University of Nebraska
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of metastatic renal cell carcinoma or metastatic melanoma
- •Must be receiving treatment with high-dose aldesleukin as part of standard therapy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
Time Frame: 10 weeks
Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2) from blood draws at baseline, prior to course 2 and 4 weeks after course 2
Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2
Time Frame: 10 weeks
Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2 from blood draws at baseline, prior to course 2 and 4 weeks after course 2
Frequency of mutations on genes encoding IL-2 receptor A and B
Time Frame: 10 weeks
Frequency of mutations on genes encoding IL-2 receptor A and B from blood draws at baseline, prior to course 2 and 4 weeks after course 2