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NCT00993135 Clinical Trial

Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:
Renal Dysfunction With Low to Intermediate Dose Methotrexate in Acute Lymphoblastic Leukemia Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00993135
Other study ID # CDR0000652517
Secondary ID P30CA068485VU-VI
Status Completed
Phase N/A
First received October 9, 2009
Last updated April 6, 2017
Start date December 2008

Study information
Verified date April 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.

Description:

OBJECTIVES:

- Examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate.

OUTLINE: Medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of acute lymphoblastic leukemia

- Receiving low- to intermediate-dose methotrexate or received treatment (chemotherapy and/or radiation) at Vanderbilt Children's Hospital

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• methotrexate

Other:
• medical chart review

Procedure:
• assessment of therapy complications

Locations
Country Name City State
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center - Cool Springs Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt University Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate
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