Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2
19 Years
N/A
Both
Kidney Cancer, Melanoma (Skin)
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 |
