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Completed

NCT Number: NCT01176981

Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 6 years of age;
  • Localized or metastatic osteosarcoma;
  • Adequate renal function (GFR > 70 ml/1.73m2) prior to each cycle;
  • No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle;
  • Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English.

Exclusion criteria

  • Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal.
  • Pregnant females
  • Breastfeeding females

Treatment and study plan

High Dose Methotrexate

Drug

Methotrexate will be given by IV at a dose of 12 gram/m2/dose.

The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).

Primary outcomes

  1. The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.

    Time frame: 9 months

    Patients will be evaluated prior to and daily during each outpatient HDMTX course, and if one or more of a list of hospitalization criteria are met, the patient will be admitted to hospital to complete that course.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2010
Registry last updated
Oct 28, 2021

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.

Published trials that share one or more normalized conditions with this study.