Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
|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:||December 2017|
|Estimated Primary Completion Date:||February 2017 (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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176981
|Contact: Abha A Gupta, MD||+1 (416) 813-7744 ext firstname.lastname@example.org|
|Contact: Nivetha Ramachandran, PhD||416-813-5076 ext email@example.com|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator: Abha Gupta, MD|
|Sub-Investigator: Tracey Taylor|
|Sub-Investigator: Janet Gammon|
|Sub-Investigator: Darcy Nicksy|
|Sub-Investigator: Ron Grant|
|Sub-Investigator: Denise Mills|
|Sub-Investigator: Eleanor Hendershot|
|Sub-Investigator: Jocelyne Volpe|
|Sub-Investigator: Ronald Grant|
|Principal Investigator:||Abha Gupta, MD||The Hospital for Sick Children, Toronto Canada|