Biomarkers That Predict Response to High-Dose Aldesleukin in Patients With Metastatic Kidney Cancer or Metastatic Melanoma
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.
Genetic: gene expression analysis
Genetic: mutation analysis
Other: flow cytometry
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2|
- Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2) [ Designated as safety issue: No ]
- Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2 [ Designated as safety issue: No ]
- Frequency of mutations on genes encoding IL-2 receptor A and B [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617799
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Principal Investigator:||Ralph Hauke, MD||University of Nebraska|