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

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ClinicalTrials.gov Identifier: NCT00617799
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ralph Hauke, University of Nebraska

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.


Condition or disease Intervention/treatment
Kidney Cancer Melanoma (Skin) Biological: aldesleukin Genetic: gene expression analysis Genetic: mutation analysis Other: flow cytometry

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.


Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2
Study Start Date : October 2007
Actual Primary Completion Date : February 18, 2009
Actual Study Completion Date : April 16, 2010





Primary Outcome Measures :
  1. Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
  2. Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2
  3. Frequency of mutations on genes encoding IL-2 receptor A and B

Biospecimen Retention:   Samples With DNA
Blood samples will be collected prior to, at mid-course and at the end of the course of IL-2 therapy.


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Ages Eligible for Study:   19 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be receiving HD IL-2.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617799


Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ralph Hauke, MD University of Nebraska

Responsible Party: Ralph Hauke, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00617799     History of Changes
Other Study ID Numbers: 278-07
P30CA036727 ( U.S. NIH Grant/Contract )
UNMC-27807
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Keywords provided by Ralph Hauke, University of Nebraska:
stage IV renal cell cancer
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents