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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Cancer; Melanoma (Skin)

Intervention: aldesleukin (Biological); gene expression analysis (Genetic); mutation analysis (Genetic); flow cytometry (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
Ralph Hauke, MD, Principal Investigator, Affiliation: University of Nebraska

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

Primary outcome:

Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)

Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2

Frequency of mutations on genes encoding IL-2 receptor A and B

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.

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-6805, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2007
Last updated: June 16, 2009

Page last updated: August 23, 2015

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