Clinical trial NCT00900380: Studying Tissue Samples to Learn More About Drug Resistance in Patients With Acute Myeloid Leukemia
Official title: Comparison of P-gp Efflux and Accumulation Assay Results With ECOG 3999 Leukemia Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute monocytic leukemia (M5b)
adult acute megakaryoblastic leukemia (M7)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
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 erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E3999

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Our Lady of Mercy Medical Center
name: Elisabeth Paietta, PhD
role: STUDY_CHAIR
References: