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
  Purpose

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


Condition Intervention Phase
Osteosarcoma
Drug: High Dose Methotrexate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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'.


Estimated Enrollment: 12
Study Start Date: October 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176981

Contacts
Contact: Eleanor Hendershot, MN NP-Peds 416-813-7515 eleanor.hendershot@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Eleanor Hendershot, MN NP-Peds    416 813 7515    eleanor.hendershot@sickkids.ca   
Principal Investigator: Eleanor Hendershot, MN NP-Peds         
Principal Investigator: Abha Gupta, MD         
Sub-Investigator: Tracey Taylor         
Sub-Investigator: Paul Gibson         
Sub-Investigator: Janet Gammon         
Sub-Investigator: Darcy Nicksy         
Sub-Investigator: Ron Grant         
Sub-Investigator: Denise Mills         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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
  More Information

No publications provided

Responsible Party: Eleanor Hendershot, Nurse Practitioner, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01176981     History of Changes
Other Study ID Numbers: 1000018144
Study First Received: August 3, 2010
Last Updated: August 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Osteosarcoma
Methotrexate
Outpatient

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014