Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
This study has been completed.
Information provided by (Responsible Party):
Abha Gupta, The Hospital for Sick Children
First received: August 3, 2010
Last updated: April 26, 2017
Last verified: April 2017
The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.
Drug: High Dose Methotrexate
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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'.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2016 (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).
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 safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.
|Ages Eligible for Study:
||6 Years to 18 Years (Child, Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- ≥ 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01176981
|The Hospital for Sick Children
|Toronto, Ontario, Canada, M5G 1X8 |
The Hospital for Sick Children
||Abha Gupta, MD
||The Hospital for Sick Children, Toronto Canada
||Abha Gupta, Staff Physician, The Hospital for Sick Children
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 3, 2010
||April 26, 2017
Keywords provided by Abha Gupta, The Hospital for Sick Children:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 27, 2017
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Abortifacient Agents, Nonsteroidal
Reproductive Control Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors