Status:
COMPLETED
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Osteosarcoma
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- ≥ 6 years of age;
- Localized or metastatic osteosarcoma;
- Adequate renal function (GFR \> 70 ml/1.73m2) prior to each cycle;
- No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle;
- Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English.
Exclusion
- Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal.
- Pregnant females
- Breastfeeding females
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01176981
Start Date
October 1 2010
End Date
October 1 2012
Last Update
October 28 2021
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8