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Multidrug Resistance Proteins in Patients Enrolled in Clinical Trials Outside of the National Cancer Institute Center for Cancer Research
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2007
First Received: May 9, 2009   No Changes Posted
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00898001
  Purpose

RATIONALE: Studying samples of tumor tissue or blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of multidrug resistance in patients.

PURPOSE: This laboratory study is looking at multidrug resistance proteins in patients enrolled in clinical trials outside of the National Cancer Institute Center for Cancer Research.


Condition Intervention
Brain and Central Nervous System Tumors
Breast Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Genetic: gene expression analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: flow cytometry
Other: immunohistochemistry staining method

Study Type: Observational
Official Title: Multidrug Resistance Molecular Target Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Expression of MDR-1 gene/P-glycoprotein and related drug resistance proteins [ Designated as safety issue: No ]

Estimated Enrollment: 9999
Study Start Date: December 2005
Detailed Description:

OBJECTIVES:

  • 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.

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.

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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".

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898001

Locations
United States, Arizona
Arizona Clinical Research Center, Incorporated Recruiting
Tucson, Arizona, United States, 85715
Contact: Manuel R. Modiano, MD     520-290-2510        
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh     412-692-5573        
United States, South Carolina
Cancer Centers of the Carolinas - Grove Commons Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jay D. Walls, MD     864-241-6251     jay.walls@usoncology.com    
Denmark
Copenhagen County Herlev University Hospital Recruiting
Copenhagen, Denmark, DK-2730
Contact: Inge M. Svane, PhD     45-44-884-488     inge.m.svane@dadlnet.dk    
University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: John Zibert     45-35-32-61-75     zibert@musling.dk    
Peru
Instituto Nacional de Enfermedades Neoplasicas Recruiting
Lima, Peru, 34
Contact: Contact Person     51-1-612-9700        
Sponsors and Collaborators
Investigators
Principal Investigator: Susan E. Bates, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000352421, NCI-04-C-N067
Study First Received: May 9, 2009
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00898001     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent childhood ependymoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood visual pathway glioma
recurrent childhood brain tumor
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
recurrent childhood cerebral astrocytoma
childhood infratentorial ependymoma
childhood oligodendroglioma
childhood supratentorial ependymoma
recurrent childhood cerebellar astrocytoma
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:
Brain Neoplasms
Skin Diseases
Astrocytoma
Brain Tumor, Childhood
Breast Neoplasms
Oligodendroglioma
Glioma
Central Nervous System Neoplasms
Breast Diseases
Recurrence
Ependymoma
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Nervous System Diseases
Breast Neoplasms
Central Nervous System Neoplasms
Breast Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009