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Completed

NCT Number: NCT00617799

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

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.

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Key information

Conditions

Kidney Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Melanoma Melanoma (Skin) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

19 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, 68198-6805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aldesleukin

Biological

gene expression analysis

Genetic

mutation analysis

Genetic

flow cytometry

Other

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Feb 18, 2008
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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