Conditions: Osteosarcoma
Keywords: pediatrics Osteosarcoma Methotrexate Outpatient
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

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.

Arms:
arm 1: This is a single arm study. All subjects enrolled in the study will be in this arm.

Interventions: intervention 1: High Dose Methotrexate
Intervention descriptions: intervention 1: 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).

Protocol document: