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

Purpose

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	Intervention
Kidney Cancer Melanoma (Skin)	Drug: aldesleukin Procedure: flow cytometry Procedure: gene expression analysis Procedure: mutation analysis

MedlinePlus related topics:

Cancer Kidney Cancer Melanoma

ChemIDplus related topics:

Aldesleukin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2) [ Designated as safety issue: No ]
Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2 [ Designated as safety issue: No ]
Frequency of mutations on genes encoding IL-2 receptor A and B [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	October 2007
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617799

Locations


United States, Nebraska
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Recruiting
	Omaha, Nebraska, United States, 68198-6805
	Contact: Mary Mailliard, RN, BSN, OCN 402-559-5582 mjmailli@unmc.edu

Sponsors and Collaborators

University of Nebraska

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Ralph Hauke, MD	University of Nebraska

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000582909, UNMC-27807
First Received:	February 15, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00617799
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV renal cell cancer

stage IV melanoma

Study placed in the following topic categories:

Urogenital Neoplasms

Renal cancer

Kidney cancer

Urologic Neoplasms

Melanoma

Carcinoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Aldesleukin

Urologic Diseases

Kidney Neoplasms

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Carcinoma, Renal Cell

Neuroepithelioma

Nevus

Kidney Diseases

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms

Anti-HIV Agents

Neoplasms by Site

Neoplasms by Histologic Type

Anti-Retroviral Agents

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Nevi and Melanomas

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University of Nebraska National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00617799