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Studying Tissue Samples to Learn More About Drug Resistance in Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900380
First received: May 9, 2009
Last updated: NA
Last verified: October 2007
History: No changes posted

May 9, 2009
May 9, 2009
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Percentage of specimens collected from patients that are found to be P-glycoprotein (P-gp)-positive by accumulation assay that were found to be negative using efflux assay [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Studying Tissue Samples to Learn More About Drug Resistance in Patients With Acute Myeloid Leukemia
Comparison of P-gp Efflux and Accumulation Assay Results With ECOG 3999 Leukemia Samples

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

PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid leukemia to learn more about drug resistance in these patients.

OBJECTIVES:

  • Ascertain whether assessments of P-glycoprotein (P-gp) status using the accumulation assay find greater than 10% positive specimens among 30 specimens (collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999) found to be negative using only the efflux assay.

OUTLINE: This is a multicenter study.

Cryopreserved bone marrow specimens are examined for P-glycoprotein (P-gp) by the accumulation assay and the efflux assay using DiOC_2 dye. Flow cytometry is used for measuring activity in both assays.

PROJECTED ACCRUAL: A total of 40 specimens will be accrued for this study.
Observational
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Leukemia
  • Other: flow cytometry
  • Other: immunological diagnostic method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
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DISEASE CHARACTERISTICS:

  • Cryopreserved bone marrow specimens collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999 meeting the following criteria:

    • Appreciable levels of either CD34+ OR CD117+ blasts
    • Appreciable staining with anti-P-gp antibodies
  • 30 specimens must exhibit low to moderate dye loading for the Rh123 efflux assay
  • 10 specimens must exhibit positive Rh123 efflux activities

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
18 Years and older
No
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NCT00900380
CDR0000478869, ECOG-E3999T1
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Elisabeth Paietta, PhD Our Lady of Mercy Medical Center Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP