Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
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|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'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|