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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Eleanor Hendershot, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01176981
First received: August 3, 2010
Last updated: August 23, 2013
Last verified: August 2013

August 3, 2010
August 23, 2013
October 2010
August 2014   (final data collection date for primary outcome measure)
The proportion of outpatient High Dose Methotrexate courses which result in an inpatient hospital admission. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01176981 on ClinicalTrials.gov Archive Site
  • The institutional costs for all the inpatient courses which occur on study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The average cost of an outpatient course [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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'.
Same as current
Not Provided
Not Provided
 
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteosarcoma
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).

Experimental: HDMTX
This is a single arm study. All subjects enrolled in the study will be in this arm.
Intervention: Drug: High Dose Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
September 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact: Eleanor Hendershot, MN NP-Peds 416-813-7515 eleanor.hendershot@sickkids.ca
Canada
 
NCT01176981
1000018144
Yes
Eleanor Hendershot, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Eleanor Hendershot, MN NP-Peds The Hospital for Sick Children, Toronto Canada
Principal Investigator: Abha Gupta, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP