Biomarkers That Predict Response to High-Dose Aldesleukin in Metastatic Kidney Cancer or Metastatic Melanoma
- Conditions
- Melanoma (Skin)Kidney Cancer
- Registration Number
- NCT00617799
- Lead Sponsor
- University of Nebraska
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Diagnosis of metastatic renal cell carcinoma or metastatic melanoma
- Must be receiving treatment with high-dose aldesleukin as part of standard therapy
none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2) 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Nebraska Medical Center, Eppley Cancer Center
🇺🇸Omaha, Nebraska, United States