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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00617799

Enrollment

Registered

2008-02-18

Start date

2007-10-02

Completion date

2010-04-16

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Melanoma (Skin)

Keywords

stage IV renal cell cancer, stage IV melanoma

Brief 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.

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.

Interventions

BIOLOGICALaldesleukin

GENETICgene expression analysis

GENETICmutation analysis

OTHERflow cytometry

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026