Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• ≥ 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 Criteria:

• 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