Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898456
First received: May 9, 2009
Last updated: September 10, 2011
Last verified: September 2011
  Purpose

RATIONALE: Studying samples of bone marrow or blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about drug resistance and how patients respond to treatment.

PURPOSE: This laboratory study is looking at multidrug resistance genes in patients with acute myeloid leukemia.


Condition Intervention
Leukemia
Genetic: gene expression analysis
Genetic: molecular genetic technique
Genetic: polymorphism analysis
Genetic: protein expression analysis
Other: diagnostic laboratory biomarker analysis

Study Type: Observational
Official Title: Multidrug Resistance Protein Gene Polymorphisms in Acute Myeloid Leukemia. A CALGB Leukemia Tissue Bank Project

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Correlation of common single nucleotide polymorphisms (SNPs) and haplotypes of the 3 multidrug resistance genes (P-glycoprotein [Pgp], multidrug resistance-associated protein (MRP-1) and breast cancer resistance protein [BCRP]) with treatment outcome [ Designated as safety issue: No ]
  • Effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms on treatment outcome [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes with Pgp, MRP-1, and BCRP function and expression in pre-treatment blasts [ Designated as safety issue: No ]
  • Effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function [ Designated as safety issue: No ]
  • Association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2006
Detailed Description:

OBJECTIVES:

Primary

  • Correlate common single nucleotide polymorphisms (SNPs) and haplotypes of the 3 multidrug resistance genes (P-glycoprotein [Pgp], multidrug resistance-associated protein (MRP-1), and breast cancer resistance protein [BCRP]) with treatment outcome in patients with acute myeloid leukemia (AML).
  • Determine the effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in younger patients enrolled on CALGB-9621 or CALGB-19808.
  • Determine the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in older patients enrolled on CALGB 9720.

Secondary

  • Determine whether ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes are associated with Pgp, MRP-1, and BCRP function and expression in pre-treatment blasts from patients with AML.
  • Determine the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function, according to the methods used in CALGB-9760, in younger patients enrolled on CALGB-9621 or CALGB-19808.
  • Determine the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function, according to the methods used in CALGB-9760, in older patients enrolled on CALGB-9720.
  • Conduct an exploratory analysis of the association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity.

OUTLINE: This is a multicenter, retrospective study.

Leukemia blast cells obtained from bone marrow aspirate or peripheral blood at diagnosis are used to study polymorphisms and haplotypes of ATP-binding cassette (ABC) B1, ABCC1, ABCG2, and other candidate genes. Multidrug resistance (MDR) protein expression and function are also analyzed using leukemia blast cells from patients enrolled on CALGB-9760.

PROJECTED ACCRUAL: Tissue samples from over 600 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia
  • Treated on protocols CALGB-9621, CALGB-9720, or CALGB-19808
  • Registered on the mandatory companion Leukemia Tissue Bank Protocol CALGB-9665

    • Registration on another companion trial, CALGB-9760, (Multidrug Resistance Studies in Acute Leukemia) allowed

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898456

Locations
United States, Indiana
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Sreenivasa R. Nattam, MD    260-484-8830      
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Maria R. Baer, MD University of Maryland Greenebaum Cancer Center
Investigator: Deanna L. Kroetz, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00898456     History of Changes
Other Study ID Numbers: CDR0000514506, CALGB-20501
Study First Received: May 9, 2009
Last Updated: September 10, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute basophilic leukemia
adult acute eosinophilic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014