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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176981
• Other study ID #: 1000018144
• Status: Completed
• Phase: Phase 3
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• High Dose Methotrexate
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).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.	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.	9 months

External Links

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