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NCT Number: NCT00898404

Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate

This laboratory study is looking at response or resistance to chemotherapy in young patients with acute lymphoblastic leukemia treated with methotrexate. Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and drug resistance in patients.

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Key information

Conditions

B-cell Childhood Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia in Remission Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia T-cell Childhood Acute Lymphoblastic Leukemia

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Arcadia, California, 91006-3776, United States

About this study

OBJECTIVES:

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of B-precursor or T-cell acute lymphoblastic leukemia
  • Newly diagnosed disease subsequently treated with methotrexate
  • Banked diagnostic blast specimens are available from Childrens Oncology Group (COG) cellbank

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Molecular basis for human reduced folate carrier (hRFC) transcripts

    Time frame: Up to 4 years

  2. Correlation of hRFC expression and methotrexate transport and sensitivities

    Time frame: Up to 4 years

  3. High frequency gene/transcript variants for hRFC in relation to response and resistance to methotrexate

    Time frame: Up to 4 years

  4. Multidrug resistance-associated proteins in relation to response and resistance to methotrexate and mercaptopurine

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Correlates of Methotrexate in Childhood ALL

Important dates

Study start
2003
Primary completion
2016
Study completion
2016
First posted
May 12, 2009
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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