Resistance to Methotrexate in Patients With Acute Lymphoblastic Leukemia in Relapse or Remission

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899899
First received: May 9, 2009
Last updated: November 20, 2010
Last verified: November 2010

May 9, 2009
November 20, 2010
June 1998
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  • Mechanisms of intrinsic and acquired methotrexate resistance [ Designated as safety issue: No ]
  • Correlation of acquired methotrexate resistance with dosage or timing of methotrexate administration [ Designated as safety issue: No ]
  • Correlation of acquired methotrexate resistance with other clinical factors [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00899899 on ClinicalTrials.gov Archive Site
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Resistance to Methotrexate in Patients With Acute Lymphoblastic Leukemia in Relapse or Remission
A Study of the Mechanisms of Intrinsic and Acquired Methotrexate Resistance in Acute Lymphocytic Leukemia

RATIONALE: Studying samples of blood 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 looking at resistance to methotrexate in patients with acute lymphoblastic leukemia in relapse or remission.

OBJECTIVES:

  • Determine the mechanisms of intrinsic and acquired methotrexate resistance using in vitro assays of matched initial diagnosis, relapsed, and nonrelapsed (control) leukemic blast samples from patients with acute lymphoblastic leukemia in relapse or remission.
  • Determine if the mechanisms of acquired methotrexate resistance are related to dosage or timing of methotrexate administration or other clinical factors in these patients.

OUTLINE: Random samples of frozen leukemic blasts from relapsing patients at initial diagnosis and relapse are selected. A corresponding sample from nonrelapsing patients (control) at initial diagnosis is also randomly selected.

Reduced folate carrier (RFC) and dehydrofolate reductase (DHFR) expression is measured using a quantitative reverse transcriptase-polymerase chain reaction assay of prepared RNA. DHFR gene amplification is measured by a dot blot analysis of prepared DNA. Results of these assays are used to determine if a particular mechanism of acquired methotrexate resistance is associated with a particular subset of acute lymphoblastic leukemia patients. Data are collected regarding the actual timing and dosage of methotrexate received by each patient and are correlated with the mechanisms of resistance.

PROJECTED ACCRUAL: A total of 135 paired samples will be accrued for this study.

Observational
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Leukemia
  • Genetic: microarray analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • 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.
 
Completed
135
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DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Acute lymphoblastic leukemia (ALL) in relapse, including all risk groups and leukemia subtypes, with frozen leukemic blast samples stored from the time of initial diagnosis and relapse
    • Non-relapsing ALL (as control)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00899899
CDR0000078589, COG-B977
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Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Richard Gorlick, MD Children's Hospital at Montefiore
National Cancer Institute (NCI)
November 2010

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