Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate
NCT ID: NCT00898404
Last Updated: 2016-05-11
Study Results
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Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2003-11-30
2016-05-31
Brief Summary
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Detailed Description
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I. Determine the molecular basis for human reduced folate carrier (hRFC) transcripts in B-precursor and T-cell acute lymphoblastic leukemia (ALL) blasts obtained from children with newly diagnosed ALL subsequently treated with methotrexate.
II. Correlate hRFC expression in these specimens with methotrexate transport and sensitivities.
III. Determine the roles of high frequency gene/transcript variants for hRFC as determinants of response and resistance to methotrexate in these patients.
IV. Determine the roles of multidrug resistance-associated proteins as determinants of response and resistance to methotrexate and mercaptopurine in these patients.
OUTLINE: This is a multicenter study.
Tumor diagnostic specimens from patients who subsequently failed therapy within 4 years of diagnosis or who did not fail therapy within 4 years of diagnosis (control patients) are obtained from the Children's Oncology Group cellbank. Specimens are studied for molecular determinants of human reduced folate carrier (hRFC) gene expression and gene sequence alterations using reverse transcriptase-polymerase chain reaction (RT-PCR), thymidylate synthase inhibition assay, Rnase protection assay, or 5'RACE. Multidrug resistance proteins are also studied by RT-PCR.
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Arm I
Tumor diagnostic specimens from patients who subsequently failed therapy within 4 years of diagnosis or who did not fail therapy within 4 years of diagnosis (control patients) are obtained from the Children's Oncology Group cellbank. Specimens are studied for molecular determinants of human reduced folate carrier (hRFC) gene expression and gene sequence alterations using reverse transcriptase-polymerase chain reaction (RT-PCR), thymidylate synthase inhibition assay, Rnase protection assay, or 5'RACE. Multidrug resistance proteins are also studied by RT-PCR.
laboratory biomarker analysis
Correlative studies
Interventions
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laboratory biomarker analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed disease subsequently treated with methotrexate
* Banked diagnostic blast specimens are available from Childrens Oncology Group (COG) cellbank
17 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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Larry Matherly
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Oncology Group
Arcadia, California, United States
Countries
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Other Identifiers
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NCI-2009-00308
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000346452
Identifier Type: OTHER
Identifier Source: secondary_id
COG-AALL04B1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL04B1
Identifier Type: -
Identifier Source: org_study_id
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