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

Primary Purpose

Osteosarcoma

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
High Dose Methotrexate
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring pediatrics, Osteosarcoma, Methotrexate, Outpatient

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HDMTX

Arm Description

This is a single arm study. All subjects enrolled in the study will be in this arm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2010
Last Updated
October 27, 2021
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01176981
Brief Title
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Official Title
Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
pediatrics, Osteosarcoma, Methotrexate, Outpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HDMTX
Arm Type
Experimental
Arm Description
This is a single arm study. All subjects enrolled in the study will be in this arm.
Intervention Type
Drug
Intervention Name(s)
High Dose Methotrexate
Intervention Description
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).
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abha Gupta, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://pubmed.ncbi.nlm.nih.gov/29965827/
Description
Related Info

Learn more about this trial

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

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