Spots Global Cancer Trial Database for Biomarkers That Predict Response to High-Dose Aldesleukin in Metastatic Kidney Cancer or Metastatic Melanoma

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Trial Identification

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

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

Study ID: NCT00617799

Conditions

Kidney Cancer

Melanoma (Skin)

Interventions

aldesleukin

gene expression analysis

mutation analysis

flow cytometry

Study Description

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.