Osteosarcoma
Conditions
Keywords
pediatrics, Osteosarcoma, Methotrexate, Outpatient
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 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.
Interventions
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).
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission. | 9 months | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HDMTX This is a single arm study. All subjects enrolled in the study will be in this arm.
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). | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | HDMTX |
|---|---|
| Age, Continuous | 13.5 years |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.
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.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HD MTX | The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission. | 0 courses of MTX |