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


N/A
19 Years
N/A
Open (Enrolling)
Both
Kidney Cancer, Melanoma (Skin)

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Ralph Hauke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

CDR0000582909

NCT ID:

NCT00617799

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • stage IV renal cell cancer
  • stage IV melanoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma

Name

Location
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680