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

University of Nebraska

Status

Completed

Conditions

Melanoma (Skin)

Kidney Cancer

Treatments

Genetic: mutation analysis

Other: flow cytometry

Genetic: gene expression analysis

Biological: aldesleukin

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00617799

P30CA036727 (U.S. NIH Grant/Contract)

0278-07-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

19 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria