Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
|ClinicalTrials.gov Identifier: NCT01176981|
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma||Drug: High Dose Methotrexate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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).
- The proportion of outpatient High Dose Methotrexate courses which result in an inpatient hospital admission. [ Time Frame: 2 years ]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 ]
- The average cost of an outpatient course [ Time Frame: 2 years ]
- 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) ]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'.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176981
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Abha Gupta, MD||The Hospital for Sick Children, Toronto Canada|