Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Recruitment status was Not yet recruiting
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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 |
- 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.
- 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 2012 |
| Estimated Primary Completion Date: | September 2012 (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 |
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| Contact: Eleanor Hendershot, MN NP-Peds | 416-813-7515 | eleanor.hendershot@sickkids.ca |
| Canada, Ontario | |
| The Hospital for Sick Children | Not yet 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 | |
| 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: | Ms. Eleanor Hendershot / Principal Investigator, 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: | September 14, 2010 |
| 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 May 22, 2013