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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma|
- The proportion of outpatient High Dose Methotrexate courses which result in an inpatient hospital admission. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
- The institutional costs for all the inpatient courses which occur on study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- The average cost of an outpatient course [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Patient and parent satisfaction [ Time Frame: After the first outpatient course (Day 4 or 5 (anticipated)) and at the end of participation in the study (up to 10 months) ] [ Designated as safety issue: No ]The tool will utilize a 5 point visual analog scale and include assessments of the following items: home medication administration, measuring urine pH, pump/supplies, MD support, education and instruction. Any score ≥ 3 will be considered as 'satisfied'.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
This is a single arm study. All subjects enrolled in the study will be in this arm.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176981
|Contact: Eleanor Hendershot, MN NP-Pedsfirstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Eleanor Hendershot, MN NP-Peds 416 813 7515 email@example.com|
|Principal Investigator: Eleanor Hendershot, MN NP-Peds|
|Principal Investigator: Abha Gupta, MD|
|Sub-Investigator: Tracey Taylor|
|Sub-Investigator: Paul Gibson|
|Sub-Investigator: Janet Gammon|
|Sub-Investigator: Darcy Nicksy|
|Sub-Investigator: Ron Grant|
|Sub-Investigator: Denise Mills|
|Principal Investigator:||Eleanor Hendershot, MN NP-Peds||The Hospital for Sick Children, Toronto Canada|
|Principal Investigator:||Abha Gupta, MD||The Hospital for Sick Children, Toronto Canada|