Overview

This trial is active, not recruiting.

Conditions kidney cancer, melanoma (skin)
Treatments aldesleukin, gene expression analysis, mutation analysis, flow cytometry
Sponsor University of Nebraska
Collaborator National Cancer Institute (NCI)
Start date October 2007
End date December 2012
Trial size 15 participants
Trial identifier NCT00617799, CDR0000582909, UNMC-27807

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Measure
Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
time frame:
Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2
time frame:
Frequency of mutations on genes encoding IL-2 receptor A and B
time frame:

Eligibility Criteria

Male or female participants at least 19 years old.

DISEASE CHARACTERISTICS: - Diagnosis of metastatic renal cell carcinoma or metastatic melanoma - Must be receiving treatment with high-dose aldesleukin as part of standard therapy PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Additional Information

Official title Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2
Principal investigator Ralph Hauke, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).