Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    12081583 [PUBMED-IDS]

Prediction of Excretion and Toxicity of High Dose Methotrexate in Children and Adolescents With ALL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02133599
Recruitment Status : Active, not recruiting
First Posted : May 8, 2014
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Walz, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary:

Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States. (For the purposes of this protocol, ALL will be used to refer to patients with either acute lymphoblastic leukemia or acute lymphoblastic lymphoma as patients are treated in the same manner.) High-dose methotrexate (HDMTX; 5 g/m2) remains an important component of standard treatment for most ALL patients. However, high plasma and intracellular MTX concentrations (defined as a MTX level of >1 µmol/L at 42 hours and > 0.40 µmol/L at 48 hours) can quickly lead to acute kidney, bone marrow, liver, skin, central nervous system, and gastrointestinal toxicities requiring extended hospitalization and delays in subsequent chemotherapy treatments.

This study seeks to identify more sensitive markers of kidney injury that could serve as better predictors of delayed excretion and/or toxicity of HDMTX. This study is a pilot repeated-measures feasibility study.

Hypothesis 1: Directly measured GFR (mGFR, a type of test to measure the filtering rate of kidneys) by iohexol clearance obtained prior to HDMTX will demonstrate greater sensitivity and specificity for prediction of delayed MTX excretion and/or toxicity in children and adolescents with ALL than serum creatinine (sCr) alone or sCr used for eGFR calculation. If this study proves that mGFR is a better predictor of delayed MTX excretion and/or toxicity, then another study will be developed in the future to determine if modifying the HDMTX dose or adjusting supportive care based on mGFR will prevent delayed clearance and toxicity without impacting patient survival.

Hypothesis 2: Those participants prospectively demonstrating delayed MTX excretion or toxicity will exhibit elevation of kidney injury biomarkers less than 24 hours following initiation of HDMTX infusion compared to pre-chemotherapy measurements. These biomarkers will increase prior to a measurable sCr elevation.


Condition or disease Intervention/treatment Phase
ALL Drug: IOHEXOL Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prediction of Excretion and Toxicity of High Dose Methotrexate in Children and Adolescents With Acute Lymphoblastic Leukemia and Lymphoma
Actual Study Start Date : July 24, 2014
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Iohexol
All patients will receive two Iohexol clearance tests, 5 mL each time before cycle 1 and 4 of HDMTX
Drug: IOHEXOL
Patients receive 5 mL of Iohexol prior to cycle 1 and 4 of HDMTX
Other Name: Iohexol, Omnipaque 300




Primary Outcome Measures :
  1. Change in Iohexol clearance results [ Time Frame: An expected average of 6 weeks or more between the two Iohexol clearances ]
    A change from baseline Iohexol clearance results after about six weeks


Secondary Outcome Measures :
  1. Change in serum creatinine [ Time Frame: An expected average of about 6 weeks between measures ]
    A change from baseline serum creatinine results after about six weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma (ALL) in patients in first remission at the start of Interim Maintenance I. HDMTX is administered during the phase of chemotherapy referred to as "Interim Maintenance I". Interim maintenance I occurs after induction and consolidation, is approximately 64 days in duration, and involves administration of four doses of HDMTX, with a dose given approximately every two weeks.
  • Age 2-21 years with a weight of ≥ 13.2 lbs. and a hemoglobin ≥ 7.0
  • Karnofsky/Lansky performance score of ≥ 50 (See Appendix II).
  • Patients must receive high-dose Methotrexate (HDMTX; 5g/m2) as part of their standard or COG study chemotherapy. The current COG protocols which involve HDMTX include the following: AALL0232, AALL0434, and AALL1131.
  • Patients must have a negative urine pregnancy test prior to enrollment and cannot be lactating.
  • All subjects must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

  • Hypersensitivity to iohexol, iodine, other contrast material
  • Hypersensitivity to shellfish
  • Prior treatment with HDMTX

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133599


Locations
Layout table for location information
United States, Illinois
Ann & Robert H. Lurie Children's Hosptial of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Layout table for investigator information
Study Chair: Amy Walz, MD Ann & Robert H. Lurie Children's Hosptial of Chicago

Publications:

Layout table for additonal information
Responsible Party: Amy Walz, MD, Attending Physician-Hematology, Oncology, Neuro-Oncology, and Stem Cell Transplant, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02133599     History of Changes
Other Study ID Numbers: CMH 14CC06
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors