Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Study Details
Study Description
Brief Summary
The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: HDMTX 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).
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
Sponsors and Collaborators
- The Hospital for Sick Children
Investigators
- Principal Investigator: Abha Gupta, MD, The Hospital for Sick Children, Toronto Canada
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1000018144
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | HDMTX |
---|---|
Arm/Group Description | 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). |
Period Title: Overall Study | |
STARTED | 6 |
COMPLETED | 6 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | HDMTX |
---|---|
Arm/Group Description | 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). |
Overall Participants | 6 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
13.5
|
Sex: Female, Male (Count of Participants) | |
Female |
4
66.7%
|
Male |
2
33.3%
|
Outcome Measures
Title | The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission. |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | HD MTX |
---|---|
Arm/Group Description | all patients received outpatient HD MTX |
Measure Participants | 6 |
Measure courses of MTX | 72 |
Number [courses of MTX] |
0
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | HDMTX | |
Arm/Group Description | 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). | |
All Cause Mortality |
||
HDMTX | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
HDMTX | ||
Affected / at Risk (%) | # Events | |
Total | 0/6 (0%) | |
Other (Not Including Serious) Adverse Events |
||
HDMTX | ||
Affected / at Risk (%) | # Events | |
Total | 0/6 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Abha Gupta |
---|---|
Organization | Hospital for Sick Children |
Phone | 14168137744 |
abha.gupta@sickkids.ca |
- 1000018144