Resistance to Methotrexate in Patients With Acute Lymphoblastic Leukemia in Relapse or Remission
NCT ID: NCT00899899
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
135 participants
OBSERVATIONAL
1998-06-30
2006-04-30
Brief Summary
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PURPOSE: This laboratory study is looking at resistance to methotrexate in patients with acute lymphoblastic leukemia in relapse or remission.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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microarray analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Richard Gorlick, MD
Role: STUDY_CHAIR
Children's Hospital at Montefiore
Other Identifiers
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COG-B977
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000078589
Identifier Type: OTHER
Identifier Source: secondary_id
B977
Identifier Type: -
Identifier Source: org_study_id
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