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

Study 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.

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

Conditions
-----------------
Kidney Cancer, Melanoma (Skin)

Intervention / Treatment
-----------------
* Biological: aldesleukin
* Genetic: gene expression analysis
* Genetic: mutation analysis
* Other: flow cytometry


Participation Criteria
=================
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: none

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Other: flow cytometry|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2) | 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 | 10 weeks | 
| Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2 | 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 | 10 weeks | 
| Frequency of mutations on genes encoding IL-2 receptor A and B | 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 | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV renal cell cancer, stage IV melanoma