Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Multidrug Resistance Proteins in Patients Enrolled in Clinical Trials Outside of the National Cancer Institute Center for Cancer Research

Basic Trial Information

Special Category: NIH Clinical Center trial

Objectives

1. Determine expression of MDR-1 gene/P-glycoprotein and related drug resistance proteins in tumor tissue samples from patients enrolled in clinical trials outside of the National Cancer Institute Center for Cancer Research.

Entry Criteria

Disease Characteristics:

• Currently enrolled on an approved cancer therapeutics clinical trial*

   [Note: *Tumor tissue samples will be analyzed from patients who received chemotherapy and the P-glycoprotein inhibitor, cyclosporine, according to a clinical trial at Children's Hospital of Pittsburgh, titled "Phase II Trial of High-Dose Cyclosporine, Etoposide Phosphate, Carboplatin, and Vincristine in Pediatric Patients With Recurrent Ependymomas and Non-Brainstem Gliomas"; breast cancer samples obtained from Denmark will be analyzed according to a clinical trial at Herlev Hospital titled "Investigation of MRD and Prognostic Markers from Patients With Primary Surgical Cancer Mammae". ]

Prior/Concurrent Therapy:

• See Disease Characteristics

Patient Characteristics:

• Not specified

Expected Enrollment

An unlimited number of patient samples will be accrued for this study.

Outcomes

Expression of MDR-1 gene/P-glycoprotein and related drug resistance proteins

Outline

Tumor tissue or blood samples that have been previously collected from patients are analyzed for P-glycoprotein and other multidrug transporters (e.g., MRP-1 and ABCG2) by immunohistochemistry, microarray analysis, and reverse transcriptase-polymerase chain reaction.

The identity of individual patients remains confidential. No results of sample analyses are provided to patients or family members.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Susan Bates, MD, Principal investigator		Ph: 301-402-1357 Email: sebates@helix.nih.gov

U.S.A.
Arizona
	Tucson
	Arizona Clinical Research Center, Incorporated
		Manuel Modiano, MD	Ph:  520-290-2510
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Philip Ludbrook, MD	Ph:  314-747-7222 800-600-3606
Pennsylvania
	Pittsburgh
	Children's Hospital of Pittsburgh of UPMC
		Clinical Trials Office - Children's Hospital of Pittsburgh	Ph:  412-692-7056
South Carolina
	Greenville
	Cancer Centers of the Carolinas - Grove Commons
		Jay Walls, MD	Ph:  864-241-6251
			Email: jay.walls@usoncology.com
Denmark
	Copenhagen
	Copenhagen County Herlev University Hospital
		Inge Svane, PhD	Ph:  45-44-884-488
			Email: inge.m.svane@dadlnet.dk
	University of Copenhagen
		John Zibert	Ph:  45-35-32-61-75
			Email: zibert@musling.dk
Peru
	Lima
	Instituto Nacional de Enfermedades Neoplasicas
		Contact Person	Ph:  51-1-612-9700

Registry Information
Official Title		Multidrug Resistance Molecular Target Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute
Trial Start Date		2005-12-27
Registered in ClinicalTrials.gov		NCT00898001
Date Submitted to PDQ		2003-12-24
Information Last Verified		2007-07-23

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