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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617799
• Other study ID #: 0278-07-FB
• Secondary ID: P30CA036727
• Status: Completed
• Start date: October 2, 2007
• Est. completion date: April 16, 2010

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 16, 2010
• Est. primary completion date: February 18, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

Inclusion Criteria:

• Diagnosis of metastatic renal cell carcinoma or metastatic melanoma

• Must be receiving treatment with high-dose aldesleukin as part of standard therapy

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

Genetic:
• gene expression analysis

• mutation analysis

Other:
• flow cytometry

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Eppley Cancer Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)	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	10 weeks
Primary	Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2	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	10 weeks
Primary	Frequency of mutations on genes encoding IL-2 receptor A and B	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	10 weeks