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

Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Molecular Correlates of Methotrexate in Childhood ALL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898404
• Other study ID #: AALL04B1
• Secondary ID: NCI-2009-00308CD
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 9, 2016
• Start date: November 2003
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• B-cell Childhood Acute Lymphoblastic Leukemia
• Childhood Acute Lymphoblastic Leukemia in Remission
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia
• T-cell Childhood Acute Lymphoblastic Leukemia

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Arcadia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular basis for human reduced folate carrier (hRFC) transcripts		Up to 4 years	No
Primary	Correlation of hRFC expression and methotrexate transport and sensitivities		Up to 4 years	No
Primary	High frequency gene/transcript variants for hRFC in relation to response and resistance to methotrexate		Up to 4 years	No
Primary	Multidrug resistance-associated proteins in relation to response and resistance to methotrexate and mercaptopurine		Up to 4 years	No