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

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT01176981
Collaborator
(none)
6
1
1
24
0.2

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
  • Drug: High Dose Methotrexate
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

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

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

  1. 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

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
Abha Gupta, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01176981
Other Study ID Numbers:
  • 1000018144
First Posted:
Aug 6, 2010
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Abha Gupta, Staff Physician, The Hospital for Sick Children
Additional relevant MeSH terms:

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

1. Primary Outcome
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

[Not Specified]

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
Email abha.gupta@sickkids.ca
Responsible Party:
Abha Gupta, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01176981
Other Study ID Numbers:
  • 1000018144
First Posted:
Aug 6, 2010
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021