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

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

Detailed Description
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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.

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

Conditions
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Osteosarcoma

Intervention / Treatment
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* Drug: High Dose Methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HDMTX<br>This is a single arm study. All subjects enrolled in the study will be in this arm. | Drug: High Dose Methotrexate<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, Osteosarcoma, Methotrexate, Outpatient