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

Phase 3

Completed

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

Detailed 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 & 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

Arm && Interventions

Group	Intervention	Description
HDMTX	High Dose Methotrexate	This is a single arm study. All subjects enrolled in the study will be in this arm.

Primary Outcome Measures

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

Secondary Outcome Measures